niacinamide has been researched along with Shingles in 11 studies
nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.
Excerpt | Relevance | Reference |
---|---|---|
" Incidence rates per 100 patient-years of adverse events of special interest were calculated, and Cox proportional hazard analysis was conducted." | 3.11 | Impact of age on the efficacy and safety of peficitinib (ASP015K) for the treatment of rheumatoid arthritis. ( Fukuda, M; Kaneko, Y; Kato, D; Miyatake, D; Takeuchi, T; Tanaka, Y, 2022) |
" Treatment-emergent adverse events (TEAEs) were reported in 757/843 (89." | 2.94 | Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan. ( Chen, YH; Izutsu, H; Kaneko, Y; Kawakami, A; Nakashima, Y; Rokuda, M; Shiomi, T; Song, YW; Takeuchi, T; Tanaka, S; Tanaka, Y; Ushijima, S; Yamada, E, 2020) |
" Secondary endpoints (assessed throughout) included ACR20, ACR50 and ACR70 response, changes from baseline in disease activity scores (DAS)28 and ACR core parameters, adverse events (AEs) and changes in clinical or laboratory measurements." | 2.90 | Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). ( Akazawa, R; Chen, YH; Iwasaki, M; Izutsu, H; Kaneko, Y; Kawakami, A; Lee, SH; Rokuda, M; Shiomi, T; Song, YW; Takeuchi, T; Tanaka, S; Tanaka, Y; Ushijima, S; Wei, JC; Yamada, E, 2019) |
"The treatment of rheumatoid arthritis has changed dramatically over the last two decades since the development of biological disease-modifying anti-rheumatic drugs (bDMARDs)." | 2.66 | JAK inhibitors for the treatment of rheumatoid arthritis. ( Morinobu, A, 2020) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 2 (18.18) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 1 (9.09) | 29.6817 |
2010's | 3 (27.27) | 24.3611 |
2020's | 5 (45.45) | 2.80 |
Authors | Studies |
---|---|
Tanaka, Y | 5 |
Takeuchi, T | 5 |
Kato, D | 2 |
Kaneko, Y | 6 |
Fukuda, M | 2 |
Miyatake, D | 1 |
Izutsu, H | 4 |
Rokuda, M | 4 |
Tanaka, S | 3 |
Kawakami, A | 3 |
Song, YW | 2 |
Chen, YH | 2 |
Ushijima, S | 3 |
Nakashima, Y | 1 |
Shiomi, T | 3 |
Yamada, E | 3 |
Morinobu, A | 1 |
Iwasaki, M | 2 |
Katayama, K | 1 |
van der Heijde, D | 1 |
Wei, JC | 1 |
Lee, SH | 1 |
Akazawa, R | 1 |
Aunhachoke, K | 1 |
Bussaratid, V | 1 |
Chirachanakul, P | 1 |
Chua-Intra, B | 1 |
Dhitavat, J | 1 |
Jaisathaporn, K | 1 |
Kaewkungwal, J | 1 |
Kampirapap, K | 1 |
Khuhaprema, T | 1 |
Pairayayutakul, K | 1 |
Pitisuttithum, P | 1 |
Sindhvananda, J | 1 |
Thaipisuttikul, Y | 1 |
NICKEL, G | 1 |
WALTHER, H | 1 |
KOST, W | 1 |
Medhurst, SJ | 1 |
Collins, SD | 1 |
Billinton, A | 1 |
Bingham, S | 1 |
Dalziel, RG | 1 |
Brass, A | 1 |
Roberts, JC | 1 |
Medhurst, AD | 1 |
Chessell, IP | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K[NCT01638013] | Phase 3 | 843 participants (Actual) | Interventional | 2012-06-13 | Completed | ||
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX[NCT02305849] | Phase 3 | 519 participants (Actual) | Interventional | 2014-07-25 | Completed | ||
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs[NCT02308163] | Phase 3 | 509 participants (Actual) | Interventional | 2014-08-08 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Participants who discontinued due to lack of efficacy have been reported. (NCT01638013)
Timeframe: Baseline up to week 372
Intervention | percentage of participants (Number) |
---|---|
Participants Who Completed 015K-CL-RAJ1 | 19.4 |
Participants Who Completed 015K-CL-RAJ3 | 4.9 |
Participants Who Completed 015K-CL-RAJ4 | 3.4 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ4 | -2.83 | -2.90 | -2.99 | -3.07 | -3.13 | -3.11 | -3.22 | -3.20 | -3.21 | -3.31 | -3.26 | -3.33 | -3.30 | -3.32 | -3.18 | -3.38 | -3.11 | -4.29 | -3.11 | -2.13 |
Participants Who Completed 015K-CL-RAJ3 | -2.70 | -2.68 | -2.71 | -2.85 | -2.82 | -2.78 | -2.91 | -2.81 | -2.84 | -2.92 | -3.05 | -2.98 | -3.00 | -3.14 | -3.13 | -3.08 | -3.25 | -3.04 | -2.69 | -2.00 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -0.70 | -1.03 | -1.11 | -1.43 | -1.66 | -1.83 | -1.88 | -1.96 | -2.05 | -2.03 | -2.14 | -2.18 | -2.28 | -2.28 | -2.32 | -2.39 | -2.45 | -2.59 | -2.64 | -2.54 | -2.67 | -2.76 | -2.67 | -2.68 | -2.64 | -2.73 | -2.79 | -2.73 | -2.80 | -2.83 | -2.83 | -2.75 | -2.84 | -2.77 | -2.76 | -2.77 | -2.84 | -2.62 | -2.52 | -3.07 | -5.13 | -2.14 | -1.58 |
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -22.70 | -22.39 | -22.62 | -23.41 | -23.32 | -23.01 | -23.45 | -23.20 | -23.81 | -23.81 | -24.84 | -24.86 | -25.06 | -26.95 | -25.34 | -24.54 | -22.87 | -25.35 | -22.24 | -17.97 |
Participants Who Completed 015K-CL-RAJ4 | -23.22 | -23.21 | -23.93 | -24.42 | -24.66 | -24.66 | -25.29 | -25.16 | -25.54 | -26.22 | -25.74 | -25.77 | -25.23 | -25.64 | -25.13 | -26.81 | -25.93 | -35.05 | -24.74 | -18.78 |
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -7.07 | -9.38 | -10.19 | -13.30 | -15.11 | -16.35 | -16.87 | -17.37 | -18.06 | -17.36 | -18.29 | -18.90 | -19.60 | -19.80 | -19.79 | -20.19 | -20.40 | -20.92 | -21.17 | -20.68 | -21.46 | -21.97 | -21.77 | -22.06 | -21.90 | -22.24 | -22.95 | -22.62 | -22.73 | -23.11 | -22.98 | -22.86 | -23.58 | -23.13 | -23.02 | -23.26 | -23.89 | -22.23 | -21.08 | -25.05 | -50.85 | -18.05 | -13.84 |
Higher CRP indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | mg/dL (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -1.590 | -1.528 | -1.507 | -1.552 | -1.604 | -1.534 | -1.726 | -1.501 | -1.561 | -1.565 | -1.730 | -1.519 | -1.474 | -1.731 | -1.418 | -2.088 | -1.501 | -1.570 | -1.386 | -1.262 |
Participants Who Completed 015K-CL-RAJ4 | -1.932 | -1.932 | -1.991 | -2.031 | -2.088 | -2.063 | -2.019 | -1.991 | -1.983 | -2.066 | -1.964 | -2.058 | -2.120 | -2.432 | -2.211 | -2.230 | -2.060 | -0.950 | -1.845 | -1.270 |
Higher CRP indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | mg/dL (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -0.334 | -0.752 | -0.745 | -1.032 | -1.034 | -1.176 | -1.242 | -1.237 | -1.376 | -1.296 | -1.330 | -1.361 | -1.361 | -1.367 | -1.310 | -1.456 | -1.418 | -1.485 | -1.562 | -1.507 | -1.443 | -1.609 | -1.423 | -1.576 | -1.170 | -1.506 | -1.477 | -1.374 | -1.449 | -1.440 | -1.488 | -1.498 | -1.647 | -1.580 | -1.537 | -1.263 | -1.565 | -1.452 | -1.365 | -2.179 | -2.330 | -1.072 | -0.967 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOS | EOT | |
Participants Who Completed 015K-CL-RAJ3 | -2.67 | -2.64 | -2.66 | -2.79 | -2.77 | -2.71 | -2.88 | -2.77 | -2.82 | -2.88 | -3.02 | -2.98 | -2.96 | -3.15 | -3.06 | -3.14 | -3.14 | -3.52 | -2.67 | -2.01 |
Participants Who Completed 015K-CL-RAJ4 | -2.79 | -2.82 | -2.93 | -3.01 | -3.08 | -3.06 | -3.13 | -3.12 | -3.16 | -3.22 | -3.17 | -3.19 | -3.12 | -3.25 | -3.16 | -3.34 | -3.14 | -4.01 | -3.05 | -2.13 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOS | EOT | |
Participants Who Completed 015K-CL-RAJ1 | -0.71 | -1.04 | -1.09 | -1.41 | -1.61 | -1.76 | -1.85 | -1.92 | -2.03 | -1.97 | -2.08 | -2.12 | -2.24 | -2.22 | -2.25 | -2.35 | -2.41 | -2.49 | -2.57 | -2.51 | -2.58 | -2.67 | -2.59 | -2.61 | -2.57 | -2.70 | -2.76 | -2.70 | -2.75 | -2.77 | -2.75 | -2.75 | -2.86 | -2.81 | -2.81 | -2.79 | -2.89 | -2.65 | -2.53 | -3.28 | -4.63 | -2.14 | -1.59 |
Higher ESR indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | mm/h (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -22.66 | -22.43 | -22.91 | -22.51 | -23.63 | -23.34 | -24.70 | -22.58 | -21.71 | -22.46 | -24.36 | -22.13 | -21.48 | -23.14 | -24.95 | -23.52 | -38.63 | -11.00 | -20.04 | -14.48 |
Participants Who Completed 015K-CL-RAJ4 | -27.02 | -27.72 | -28.54 | -29.41 | -30.31 | -30.06 | -30.06 | -29.23 | -29.70 | -29.97 | -29.46 | -30.35 | -31.44 | -30.77 | -29.68 | -33.46 | -26.50 | -57.00 | -26.36 | -17.26 |
Higher ESR indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | mm/h (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -2.46 | -6.65 | -6.93 | -10.54 | -11.93 | -13.39 | -14.07 | -14.45 | -15.15 | -16.20 | -16.26 | -16.27 | -15.60 | -16.09 | -16.71 | -16.78 | -16.89 | -18.81 | -19.24 | -19.48 | -19.43 | -22.19 | -20.62 | -20.58 | -16.28 | -18.86 | -19.05 | -17.85 | -20.09 | -19.24 | -20.78 | -19.11 | -20.21 | -17.57 | -19.51 | -16.81 | -17.28 | -17.51 | -16.53 | -20.63 | -28.00 | -12.52 | -8.90 |
FACIT-Fatigue was used to assess the burden of self-reported fatigue caused by a chronic disease and its impact upon daily activities and function. It has 13-items with symptom-specific questions, each of the 13 items of the FACIT-Fatigue scale ranges from 0 (Not at all) - 4 (Very much), the range of possible scores is 0 - 52. Higher scores indicate higher fatigue. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 1.71 | 4.50 | 3.29 | 4.15 | 4.85 | 5.91 | 5.86 | 5.99 | 5.95 | 5.91 | 5.91 | 6.06 | 6.05 | 6.34 | 7.18 | 5.87 | 6.11 | 6.10 | -6.0 | 5.95 | 3.67 |
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -0.43 | -0.44 | -0.43 | -0.43 | -0.42 | -0.43 | -0.44 | -0.45 | -0.42 | -0.40 | -0.48 | -0.49 | -0.49 | -0.52 | -0.41 | -0.29 | -0.25 | -0.75 | -0.37 | -0.17 |
Participants Who Completed 015K-CL-RAJ4 | -0.49 | -0.48 | -0.52 | -0.52 | -0.55 | -0.55 | -0.56 | -0.56 | -0.59 | -0.60 | -0.60 | -0.60 | -0.58 | -0.58 | -0.51 | -0.52 | -0.44 | -0.75 | -0.51 | -0.28 |
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -0.03 | -0.07 | -0.08 | -0.13 | -0.17 | -0.21 | -0.22 | -0.25 | -0.27 | -0.27 | -0.25 | -0.25 | -0.26 | -0.27 | -0.28 | -0.29 | -0.29 | -0.29 | -0.30 | -0.30 | -0.31 | -0.33 | -0.33 | -0.31 | -0.32 | -0.32 | -0.32 | -0.35 | -0.34 | -0.31 | -0.35 | -0.32 | -0.36 | -0.34 | -0.35 | -0.37 | -0.35 | -0.31 | -0.29 | -0.41 | -0.88 | -0.22 | -0.08 |
"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly." (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -41.57 | -40.22 | -40.65 | -41.60 | -41.92 | -41.84 | -42.48 | -41.31 | -43.26 | -43.55 | -45.11 | -45.51 | -45.70 | -48.04 | -45.54 | -44.62 | -33.75 | -30.00 | -39.86 | -30.01 |
Participants Who Completed 015K-CL-RAJ4 | -43.09 | -42.77 | -43.81 | -44.81 | -45.71 | -45.20 | -47.05 | -46.42 | -47.35 | -48.04 | -46.99 | -47.50 | -45.85 | -46.65 | -45.07 | -46.01 | -44.50 | -53.50 | -45.04 | -36.11 |
"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly." (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -10.77 | -13.48 | -16.78 | -20.59 | -24.33 | -26.64 | -27.12 | -27.56 | -29.22 | -27.80 | -29.94 | -31.58 | -31.60 | -33.04 | -32.82 | -33.68 | -33.39 | -34.12 | -35.70 | -35.14 | -37.24 | -39.11 | -37.72 | -39.55 | -37.34 | -39.13 | -40.46 | -40.80 | -40.08 | -41.67 | -41.55 | -41.13 | -42.46 | -42.21 | -41.40 | -42.18 | -42.73 | -39.55 | -38.71 | -40.25 | -47.00 | -30.72 | -20.31 |
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -24.30 | -23.93 | -24.13 | -25.00 | -24.93 | -24.54 | -25.17 | -24.70 | -25.37 | -25.38 | -26.57 | -26.38 | -26.53 | -28.68 | -26.75 | -26.63 | -24.37 | -26.92 | -23.68 | -19.25 |
Participants Who Completed 015K-CL-RAJ4 | -25.12 | -25.15 | -25.93 | -26.45 | -26.75 | -26.73 | -27.31 | -27.15 | -27.52 | -28.28 | -27.71 | -27.83 | -27.38 | -28.07 | -27.34 | -29.04 | -27.99 | -36.00 | -26.58 | -20.05 |
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -7.41 | -10.13 | -10.93 | -14.33 | -16.14 | -17.53 | -18.11 | -18.61 | -19.43 | -18.66 | -19.62 | -20.26 | -20.96 | -21.17 | -21.10 | -21.65 | -21.82 | -22.40 | -22.73 | -22.18 | -22.90 | -23.58 | -23.19 | -23.64 | -23.07 | -23.75 | -24.42 | -24.00 | -24.18 | -24.55 | -24.47 | -24.36 | -25.23 | -24.71 | -24.56 | -24.52 | -25.45 | -23.68 | -22.45 | -27.23 | -53.18 | -19.12 | -14.81 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | units on a scale (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | 2.94 | 2.02 | 1.74 | 2.87 | 2.10 | 2.40 | 1.56 | 2.41 | 2.23 | 1.54 |
Participants Who Completed 015K-CL-RAJ4 | 2.69 | 2.61 | 2.89 | 2.80 | 2.22 | 1.62 | 1.65 | 2.04 | 2.31 | 2.16 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 192 | Week 216 | Week 240 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | |
Participants Who Completed 015K-CL-RAJ1 | 3.00 | 3.88 | 3.85 | 4.72 | 4.61 | 4.97 | 6.01 | 5.38 | 5.13 | 5.18 | 5.70 | 5.79 | 5.52 | 5.27 | 5.28 | 5.58 | 5.42 | 3.89 | 4.64 | -2.52 | 4.38 | 2.17 | 4.09 | 3.56 | 2.95 | 3.45 | 4.03 | 6.20 | 3.72 | 11.12 | 4.62 | 7.83 | 3.78 | 2.80 | 5.15 | -3.24 | 3.63 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | units on a scale (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | 5.21 | 5.06 | 5.06 | 5.65 | 4.30 | 4.55 | 5.18 | 0.50 | -0.97 | 3.92 |
Participants Who Completed 015K-CL-RAJ4 | 5.45 | 5.56 | 5.80 | 6.37 | 5.80 | 5.92 | 5.43 | 4.11 | 2.17 | 4.74 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 192 | Week 216 | Week 240 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | |
Participants Who Completed 015K-CL-RAJ1 | -0.52 | 0.29 | 1.30 | 1.70 | 2.84 | 2.33 | 1.59 | 2.68 | 3.75 | 1.66 | 2.42 | 1.93 | 2.85 | 3.05 | 2.56 | 0.81 | 2.67 | -1.62 | 2.97 | -5.25 | 2.64 | 5.75 | 2.88 | 2.75 | 3.50 | 3.46 | 2.65 | 1.82 | 3.99 | 12.34 | 3.87 | 15.79 | 3.54 | -1.11 | 1.64 | -8.61 | 2.06 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | units on a scale (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | 11.62 | 12.55 | 12.31 | 12.35 | 12.15 | 12.59 | 12.46 | 9.64 | 10.42 | 10.29 |
Participants Who Completed 015K-CL-RAJ4 | 11.60 | 13.23 | 13.52 | 13.48 | 14.20 | 14.59 | 14.38 | 13.94 | 12.60 | 12.62 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 192 | Week 216 | Week 240 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | |
Participants Who Completed 015K-CL-RAJ1 | -0.55 | 0.30 | 1.53 | 2.52 | 4.10 | 3.72 | 3.56 | 3.97 | 4.14 | 3.63 | 4.27 | 4.49 | 4.51 | 5.89 | 4.94 | 5.59 | 5.02 | 0.27 | 5.01 | -7.23 | 6.94 | -31.60 | 6.46 | 6.43 | 6.73 | 6.13 | 5.97 | -22.64 | 6.21 | 4.73 | 6.13 | 21.10 | 4.33 | -5.21 | 6.92 | 0.16 | 3.44 |
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -37.24 | -36.80 | -37.13 | -37.33 | -36.12 | -36.18 | -36.86 | -35.33 | -35.75 | -35.54 | -38.88 | -38.66 | -38.99 | -39.62 | -38.36 | -38.41 | -49.90 | -83.50 | -33.53 | -27.86 |
Participants Who Completed 015K-CL-RAJ4 | -35.60 | -34.81 | -36.25 | -37.57 | -37.40 | -37.46 | -38.42 | -38.26 | -38.50 | -39.69 | -39.56 | -37.79 | -37.44 | -38.45 | -38.89 | -38.41 | -42.09 | -57.00 | -36.57 | -22.79 |
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -6.82 | -11.31 | -13.42 | -17.89 | -20.60 | -23.45 | -24.35 | -24.78 | -27.29 | -27.78 | -27.45 | -29.23 | -29.01 | -29.80 | -30.39 | -31.18 | -29.73 | -32.65 | -31.75 | -31.87 | -32.61 | -33.67 | -34.15 | -33.59 | -33.56 | -34.94 | -35.65 | -33.69 | -34.81 | -35.14 | -34.84 | -34.57 | -36.39 | -35.51 | -36.97 | -37.52 | -35.50 | -33.11 | -28.87 | -40.29 | -71.50 | -26.04 | -18.67 |
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -36.09 | -35.75 | -36.38 | -36.68 | -35.88 | -35.77 | -36.54 | -35.14 | -34.55 | -35.52 | -38.32 | -38.30 | -39.02 | -40.11 | -38.27 | -42.90 | -50.81 | -82.50 | -33.82 | -29.87 |
Participants Who Completed 015K-CL-RAJ4 | -34.79 | -34.27 | -36.17 | -37.30 | -37.16 | -36.93 | -37.36 | -37.58 | -37.83 | -38.72 | -38.34 | -36.66 | -36.34 | -37.08 | -36.96 | -37.85 | -40.86 | -58.00 | -35.84 | -21.54 |
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | units on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -7.37 | -11.21 | -13.10 | -17.70 | -20.54 | -23.12 | -24.00 | -24.41 | -26.74 | -27.41 | -26.73 | -28.62 | -29.08 | -30.08 | -30.88 | -30.47 | -29.41 | -31.59 | -31.16 | -31.92 | -32.42 | -33.53 | -33.61 | -34.24 | -33.40 | -34.50 | -35.88 | -33.21 | -34.44 | -34.98 | -34.88 | -34.81 | -36.12 | -34.63 | -35.73 | -35.42 | -33.43 | -32.56 | -25.96 | -35.59 | -58.60 | -26.57 | -19.77 |
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | swollen joint count (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -9.6 | -9.5 | -9.9 | -10.3 | -10.4 | -10.3 | -10.3 | -10.2 | -10.6 | -10.7 | -11.1 | -11.2 | -11.2 | -12.4 | -11.4 | -10.6 | -9.0 | -6.0 | -9.7 | -8.2 |
Participants Who Completed 015K-CL-RAJ4 | -10.5 | -10.4 | -10.8 | -11.1 | -11.0 | -11.1 | -11.3 | -11.2 | -11.3 | -11.5 | -11.4 | -11.5 | -11.3 | -11.4 | -11.7 | -11.9 | -11.3 | -17.0 | -11.1 | -9.3 |
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | swollen joint count (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -3.8 | -4.6 | -4.8 | -6.1 | -6.7 | -7.1 | -7.4 | -7.6 | -7.6 | -7.5 | -7.9 | -8.1 | -8.6 | -8.7 | -8.4 | -8.6 | -8.7 | -8.8 | -9.0 | -8.7 | -9.0 | -9.1 | -8.9 | -9.2 | -9.2 | -9.1 | -9.5 | -9.2 | -9.4 | -9.7 | -9.6 | -9.7 | -9.9 | -9.5 | -9.7 | -9.4 | -9.5 | -9.4 | -9.4 | -11.0 | -18.0 | -7.8 | -6.3 |
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | tender joint count (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | -11.7 | -11.8 | -11.9 | -12.4 | -11.9 | -11.9 | -11.9 | -11.9 | -12.3 | -12.3 | -12.7 | -12.8 | -12.9 | -14.1 | -11.8 | -12.2 | -11.8 | -8.0 | -11.5 | -9.1 |
Participants Who Completed 015K-CL-RAJ4 | -11.5 | -11.8 | -12.1 | -12.3 | -12.3 | -12.4 | -12.8 | -12.9 | -13.1 | -13.8 | -13.5 | -13.8 | -13.3 | -13.3 | -13.2 | -14.2 | -13.2 | -17.0 | -12.6 | -9.4 |
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | tender joint count (Mean) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | -4.3 | -5.3 | -5.7 | -7.7 | -8.7 | -9.4 | -9.5 | -9.8 | -10.0 | -9.5 | -10.0 | -10.4 | -10.9 | -10.7 | -10.8 | -10.4 | -10.7 | -10.8 | -10.7 | -10.6 | -10.8 | -11.1 | -11.2 | -11.3 | -11.3 | -11.4 | -11.8 | -11.7 | -11.7 | -11.7 | -11.8 | -11.7 | -12.0 | -11.5 | -11.5 | -11.9 | -12.0 | -11.5 | -11.2 | -13.8 | -23.0 | -10.2 | -8.6 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Intervention | percent work time missed (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | -5.36 | -4.81 | -4.52 | -4.73 | -4.74 | -5.15 | -3.21 | -8.65 | 0.00 | -2.76 |
Participants Who Completed 015K-CL-RAJ4 | -2.20 | -3.29 | -3.30 | -3.17 | -3.13 | -4.49 | -1.26 | -5.19 | -2.29 | -1.96 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Intervention | percent activity impairment (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | -28.16 | -27.38 | -27.81 | -28.09 | -27.92 | -29.26 | -26.39 | -20.81 | -20.00 | -25.55 |
Participants Who Completed 015K-CL-RAJ4 | -25.39 | -29.31 | -28.85 | -31.59 | -30.69 | -33.07 | -31.11 | -26.53 | -23.18 | -27.87 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Intervention | percent work impairment (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | -21.05 | -21.94 | -20.70 | -21.06 | -20.11 | -24.40 | -18.08 | -17.06 | -15.00 | -21.49 |
Participants Who Completed 015K-CL-RAJ4 | -22.18 | -24.79 | -25.17 | -27.12 | -28.54 | -30.00 | -27.16 | -23.24 | -28.00 | -24.13 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Intervention | percent overall work impairment (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | -22.24 | -22.45 | -20.80 | -21.59 | -20.58 | -24.71 | -18.29 | -19.03 | -15.00 | -20.75 |
Participants Who Completed 015K-CL-RAJ4 | -22.20 | -25.78 | -25.32 | -27.41 | -28.93 | -31.40 | -26.76 | -24.76 | -28.06 | -24.63 |
AE was defined as any untoward medical occurrence in a participant administered a study drug that did not necessarily have a causal relationship to this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug. (NCT01638013)
Timeframe: Baseline up to end of study (EOS) (up to week 376)
Intervention | Participants (Count of Participants) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Events (AE) | Drug related AE (DAE) | Deaths | Serious AE (SAE) | Drug Related serious AE (DSAE) | Grade 3 or higher in severity AE | AE leading to permanent discontinuation of study | DAE leading to permanent discontinuation of drug | SAE leading to permanent discontinuation of drug | DSAE leading to permanent discontinuation of drug | AE leading to dose reduction of study drug | DAE leading to dose reduction of study drug | AE leading to temporary discontinuation of drug | DAE leading to temporary discontinuation of drug | |
Participants Who Completed 015K-CL-RAJ1 | 193 | 175 | 0 | 59 | 22 | 75 | 50 | 30 | 23 | 11 | 4 | 4 | 81 | 67 |
Participants Who Completed 015K-CL-RAJ3 | 208 | 160 | 1 | 56 | 37 | 73 | 34 | 18 | 20 | 12 | 8 | 8 | 86 | 76 |
Participants Who Completed 015K-CL-RAJ4 | 395 | 321 | 1 | 84 | 54 | 118 | 56 | 44 | 32 | 27 | 6 | 6 | 191 | 158 |
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 18.3 | 16.9 | 20.2 | 29.1 | 25.9 | 24.1 | 29.5 | 30.0 | 26.6 | 28.7 | 29.1 | 29.3 | 30.9 | 27.1 | 35.1 | 23.8 | 25.0 | 100.0 | 25.7 | 7.7 |
Participants Who Completed 015K-CL-RAJ4 | 22.4 | 23.0 | 26.9 | 28.3 | 32.7 | 28.9 | 30.7 | 34.0 | 33.2 | 30.0 | 26.3 | 31.4 | 28.9 | 31.1 | 31.6 | 34.8 | 31.8 | 100.0 | 31.3 | 12.4 |
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 1.5 | 4.0 | 5.0 | 4.5 | 4.0 | 7.1 | 7.4 | 7.5 | 9.2 | 10.6 | 11.0 | 8.3 | 11.0 | 11.0 | 10.8 | 11.3 | 14.3 | 17.5 | 18.0 | 16.9 | 20.6 | 18.3 | 17.6 | 21.6 | 21.1 | 21.6 | 23.4 | 25.0 | 24.5 | 24.2 | 25.6 | 24.4 | 19.8 | 25.0 | 24.7 | 24.1 | 23.4 | 24.5 | 15.0 | 25.0 | 0.0 | 15.9 | 10.9 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission, DAS28-CRP <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ4 | 58.2 | 60.3 | 62.2 | 65.4 | 69.2 | 66.6 | 71.1 | 70.7 | 71.3 | 72.7 | 76.1 | 74.3 | 74.8 | 72.6 | 72.4 | 82.6 | 68.2 | 100.0 | 69.4 | 44.9 |
Participants Who Completed 015K-CL-RAJ3 | 55.4 | 53.9 | 56.3 | 58.3 | 56.3 | 57.1 | 63.9 | 60.6 | 63.6 | 62.8 | 66.9 | 65.5 | 66.0 | 71.4 | 62.2 | 66.7 | 87.5 | 100.0 | 57.2 | 35.4 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission, DAS28-CRP <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 8.0 | 13.0 | 16.1 | 15.1 | 20.2 | 23.0 | 27.4 | 26.2 | 29.9 | 29.1 | 30.8 | 36.9 | 39.9 | 39.3 | 43.9 | 46.7 | 51.4 | 54.7 | 51.1 | 57.7 | 55.6 | 60.0 | 59.7 | 61.2 | 58.8 | 64.0 | 65.4 | 63.5 | 61.2 | 65.3 | 66.7 | 62.2 | 70.9 | 63.1 | 67.9 | 65.8 | 71.9 | 60.4 | 65.0 | 81.3 | 0.0 | 45.3 | 22.8 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 73.7 | 73.1 | 72.1 | 75.2 | 75.6 | 75.9 | 79.8 | 79.4 | 80.3 | 78.0 | 85.1 | 84.5 | 82.5 | 80.0 | 78.4 | 81.0 | 87.5 | 100.0 | 71.6 | 47.7 |
Participants Who Completed 015K-CL-RAJ4 | 72.7 | 74.0 | 78.4 | 79.3 | 82.0 | 83.1 | 84.5 | 83.7 | 86.0 | 87.6 | 86.9 | 87.4 | 86.7 | 85.8 | 86.8 | 89.1 | 90.9 | 100.0 | 84.0 | 60.7 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP <2.6 = remission. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 18.5 | 24.5 | 25.1 | 33.2 | 38.9 | 42.3 | 46.8 | 49.7 | 51.6 | 50.8 | 56.4 | 59.5 | 60.1 | 61.3 | 64.3 | 64.7 | 68.6 | 75.2 | 77.4 | 74.6 | 77.0 | 81.7 | 78.2 | 76.7 | 75.4 | 76.6 | 83.2 | 75.0 | 82.7 | 80.0 | 77.8 | 82.2 | 86.0 | 83.3 | 82.7 | 83.5 | 84.4 | 77.4 | 80.0 | 100.0 | 100.0 | 61.7 | 40.6 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission, DAS28-ESR <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 30.9 | 36.1 | 35.3 | 37.4 | 39.1 | 36.1 | 47.3 | 41.0 | 39.5 | 47.6 | 46.6 | 47.8 | 48.5 | 48.6 | 54.1 | 38.1 | 37.5 | 0.0 | 42.9 | 20.0 |
Participants Who Completed 015K-CL-RAJ4 | 38.0 | 39.7 | 43.3 | 45.8 | 48.0 | 45.4 | 51.6 | 50.0 | 48.7 | 52.1 | 49.8 | 54.3 | 55.6 | 53.3 | 47.4 | 55.6 | 45.5 | 100.0 | 49.8 | 20.2 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission, DAS28-ESR <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 4.5 | 4.5 | 7.0 | 7.6 | 12.1 | 13.3 | 12.7 | 13.9 | 18.0 | 16.9 | 18.6 | 17.3 | 20.9 | 20.9 | 22.9 | 28.7 | 26.6 | 34.6 | 32.3 | 31.5 | 34.9 | 35.0 | 32.8 | 36.2 | 33.6 | 39.1 | 35.5 | 35.9 | 43.9 | 37.9 | 40.0 | 32.6 | 38.4 | 41.7 | 35.8 | 38.0 | 39.1 | 32.1 | 27.5 | 31.3 | 0.0 | 27.4 | 14.9 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 56.5 | 53.0 | 54.1 | 58.3 | 58.4 | 57.6 | 59.9 | 57.9 | 56.4 | 64.0 | 66.2 | 67.0 | 63.9 | 67.1 | 64.9 | 57.1 | 62.5 | 100.0 | 54.5 | 35.4 |
Participants Who Completed 015K-CL-RAJ4 | 55.7 | 59.6 | 62.3 | 64.7 | 65.9 | 67.3 | 69.9 | 69.8 | 71.2 | 70.8 | 71.4 | 72.6 | 71.1 | 67.6 | 69.7 | 75.6 | 68.2 | 100.0 | 67.5 | 40.4 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR <2.6 = remission. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 8.5 | 13.5 | 14.6 | 14.2 | 22.7 | 22.4 | 23.8 | 28.3 | 29.5 | 31.5 | 32.0 | 30.4 | 38.7 | 40.5 | 40.1 | 43.3 | 43.9 | 53.7 | 51.9 | 48.5 | 55.6 | 58.3 | 55.5 | 56.0 | 57.5 | 55.5 | 60.7 | 54.4 | 59.2 | 60.0 | 60.0 | 56.2 | 62.8 | 57.1 | 60.5 | 57.0 | 60.9 | 52.8 | 52.5 | 50.0 | 100.0 | 42.8 | 23.8 |
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 59.2 | 61.5 | 59.9 | 55.8 | 58.2 | 59.7 | 59.6 | 63.3 | 57.2 | 56.7 | 62.8 | 57.8 | 61.9 | 70.0 | 62.2 | 47.6 | 50.0 | 100.0 | 55.4 | 44.6 |
Participants Who Completed 015K-CL-RAJ4 | 67.0 | 65.7 | 68.3 | 71.4 | 70.6 | 71.9 | 69.9 | 69.5 | 73.9 | 73.8 | 73.2 | 74.9 | 75.0 | 76.4 | 69.7 | 71.7 | 59.1 | 100.0 | 68.9 | 56.2 |
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 35.0 | 37.0 | 40.7 | 41.7 | 48.0 | 51.0 | 49.5 | 50.3 | 54.3 | 50.0 | 48.3 | 48.8 | 50.9 | 50.3 | 54.1 | 54.0 | 53.6 | 51.8 | 54.9 | 52.3 | 53.2 | 55.8 | 53.8 | 53.4 | 57.0 | 55.0 | 51.4 | 55.8 | 52.0 | 50.5 | 54.4 | 50.0 | 54.7 | 47.6 | 54.3 | 51.9 | 51.6 | 50.9 | 47.5 | 62.5 | 100.0 | 46.8 | 44.6 |
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 61.2 | 62.1 | 64.9 | 62.8 | 58.9 | 62.8 | 67.2 | 65.6 | 63.0 | 62.2 | 69.6 | 70.7 | 71.1 | 68.6 | 73.0 | 71.4 | 87.5 | 100.0 | 62.3 | 40.0 |
Participants Who Completed 015K-CL-RAJ4 | 62.1 | 63.0 | 65.5 | 64.3 | 65.4 | 67.1 | 68.8 | 69.2 | 69.1 | 67.4 | 68.1 | 68.0 | 69.9 | 67.0 | 68.4 | 73.9 | 59.1 | 0.0 | 63.6 | 48.3 |
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 37.0 | 38.5 | 38.7 | 39.7 | 42.9 | 46.9 | 47.4 | 48.7 | 50.5 | 50.0 | 51.2 | 52.4 | 55.2 | 54.0 | 55.4 | 60.0 | 62.9 | 62.0 | 62.4 | 63.1 | 66.7 | 66.7 | 65.5 | 67.2 | 68.4 | 67.6 | 67.3 | 72.1 | 70.4 | 68.4 | 68.9 | 67.8 | 72.1 | 70.2 | 69.1 | 67.1 | 70.3 | 62.3 | 60.0 | 56.3 | 100.0 | 52.7 | 35.6 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | percentage of participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | 39.9 | 37.2 | 33.2 | 39.3 | 33.5 | 37.2 | 30.9 | 32.4 | 37.5 | 35.8 |
Participants Who Completed 015K-CL-RAJ4 | 37.4 | 37.6 | 39.2 | 35.8 | 38.4 | 33.8 | 28.7 | 34.2 | 31.8 | 34.6 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 192 | Week 216 | Week 240 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | |
Participants Who Completed 015K-CL-RAJ1 | 43.0 | 42.7 | 47.2 | 43.4 | 45.4 | 45.3 | 51.9 | 47.8 | 48.3 | 47.7 | 49.4 | 49.1 | 51.5 | 48.6 | 53.7 | 57.1 | 49.6 | 50.0 | 45.4 | 0 | 47.5 | 0 | 41.4 | 39.6 | 37.5 | 42.1 | 43.3 | 100 | 41.7 | 100 | 43.0 | 33.3 | 37.7 | 22.2 | 43.8 | 0 | 39.8 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | percentage of participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | 70 | 70.5 | 73.0 | 68.3 | 71.7 | 68.2 | 66.0 | 70.3 | 62.5 | 61.0 |
Participants Who Completed 015K-CL-RAJ4 | 71.1 | 74.1 | 74.7 | 73.9 | 75.9 | 79.3 | 82.4 | 77.6 | 77.3 | 306 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 192 | Week 216 | Week 240 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | |
Participants Who Completed 015K-CL-RAJ1 | 34.0 | 33.7 | 40.2 | 39.4 | 43.4 | 40.0 | 44.4 | 42.9 | 44.4 | 45.3 | 47.0 | 47.2 | 45.4 | 47.8 | 47.7 | 50.6 | 43.8 | 50.0 | 44.6 | 0 | 53.3 | 0 | 50.0 | 52.3 | 51.9 | 53.7 | 52.2 | 0 | 48.8 | 0 | 48.1 | 66.7 | 43.4 | 11.1 | 56.3 | 0 | 41.8 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | percentage of participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 24 | Week 48 | Week 72 | Week 96 | Week 120 | Week 144 | Week 168 | Week 192 | EOT | |
Participants Who Completed 015K-CL-RAJ3 | 44.8 | 47.8 | 46.4 | 47.5 | 42.8 | 45.3 | 51.5 | 35.1 | 25.0 | 43.1 |
Participants Who Completed 015K-CL-RAJ4 | 48.5 | 48.0 | 47.1 | 46.7 | 48.2 | 49.3 | 48.5 | 40.8 | 31.8 | 44.7 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 192 | Week 216 | Week 240 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | |
Participants Who Completed 015K-CL-RAJ1 | 26.0 | 27.6 | 35.7 | 39.9 | 39.8 | 38.4 | 36.4 | 39.1 | 40.0 | 33.1 | 38.7 | 38.7 | 40.5 | 39.9 | 38.9 | 29.9 | 38.7 | 0 | 39.2 | 0 | 38.3 | 100 | 39.7 | 38.7 | 40.0 | 41.1 | 37.8 | 0 | 42.9 | 100.0 | 45.6 | 83.3 | 39.6 | 22.2 | 31.3 | 0.0 | 39.8 |
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 23.7 | 24.2 | 29.3 | 30.6 | 33.5 | 28.3 | 36.6 | 33.9 | 37.6 | 37.2 | 39.9 | 44.0 | 42.3 | 41.4 | 51.4 | 33.3 | 25.0 | 0.0 | 34.5 | 12.3 |
Participants Who Completed 015K-CL-RAJ4 | 30.6 | 30.6 | 36.0 | 39.1 | 42.2 | 40.7 | 42.4 | 42.6 | 42.7 | 40.4 | 39.0 | 42.3 | 44.9 | 40.6 | 43.4 | 43.5 | 45.5 | 100.0 | 42.5 | 25.8 |
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 3.0 | 4.0 | 4.5 | 6.0 | 5.6 | 7.7 | 8.9 | 11.8 | 14.1 | 16.8 | 15.1 | 13.7 | 15.3 | 19.6 | 14.0 | 18.7 | 20.0 | 23.4 | 26.3 | 23.1 | 25.4 | 25.0 | 19.3 | 28.4 | 28.1 | 30.6 | 29.9 | 33.7 | 33.7 | 34.7 | 30.0 | 31.1 | 31.4 | 38.1 | 30.9 | 31.6 | 34.4 | 26.4 | 20.0 | 31.3 | 0.0 | 24.9 | 14.9 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ4 | 94.6 | 94.9 | 96.2 | 96.9 | 97.3 | 96.1 | 96.3 | 96.4 | 97.7 | 98.1 | 96.7 | 97.7 | 96.3 | 98.1 | 98.7 | 97.8 | 95.5 | 100.0 | 95.4 | 83.1 |
Participants Who Completed 015K-CL-RAJ3 | 94.2 | 92.7 | 95.2 | 95.1 | 94.9 | 93.7 | 95.1 | 95.0 | 94.2 | 93.9 | 98.0 | 94.0 | 90.7 | 97.1 | 94.6 | 95.2 | 87.5 | 100.0 | 89.2 | 80.0 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 48.5 | 60.5 | 65.8 | 75.4 | 79.8 | 81.6 | 84.2 | 84.5 | 88.0 | 88.3 | 91.3 | 92.9 | 93.3 | 92.0 | 94.9 | 92.7 | 92.1 | 94.2 | 95.5 | 93.1 | 92.1 | 95.0 | 94.1 | 94.0 | 93.9 | 95.5 | 96.3 | 94.2 | 93.9 | 94.7 | 93.3 | 91.1 | 95.3 | 94.0 | 93.8 | 94.9 | 98.4 | 98.1 | 92.5 | 100.0 | 100.0 | 78.6 | 72.3 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 89.7 | 91.3 | 92.3 | 92.2 | 94.4 | 92.1 | 91.2 | 92.7 | 94.2 | 91.5 | 93.9 | 89.6 | 87.6 | 95.7 | 86.5 | 90.5 | 87.5 | 100.0 | 87.1 | 80.0 |
Participants Who Completed 015K-CL-RAJ4 | 93.4 | 92.2 | 95.4 | 95.5 | 95.1 | 94.9 | 96.0 | 95.9 | 97.1 | 97.4 | 96.2 | 97.7 | 97.0 | 96.2 | 96.1 | 93.3 | 95.5 | 100.0 | 93.7 | 82.0 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 41.5 | 54.5 | 59.3 | 70.1 | 75.8 | 78.1 | 85.2 | 84.0 | 87.4 | 84.8 | 91.3 | 89.3 | 93.3 | 92.6 | 93.0 | 90.7 | 89.9 | 92.6 | 92.5 | 91.5 | 92.1 | 93.3 | 94.1 | 92.2 | 93.8 | 94.5 | 95.3 | 93.2 | 92.9 | 92.6 | 92.2 | 92.1 | 94.2 | 92.9 | 95.1 | 94.9 | 96.9 | 94.3 | 92.5 | 100.0 | 100.0 | 76.6 | 67.3 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 71.0 | 70.3 | 70.2 | 72.3 | 73.1 | 71.7 | 76.5 | 75.0 | 77.5 | 75.6 | 83.8 | 80.2 | 80.4 | 75.7 | 75.7 | 76.2 | 87.5 | 100.0 | 69.4 | 43.1 |
Participants Who Completed 015K-CL-RAJ4 | 71.0 | 72.3 | 77.2 | 78.2 | 80.1 | 82.3 | 84.0 | 82.0 | 84.0 | 85.8 | 85.4 | 85.7 | 85.2 | 84.9 | 86.8 | 84.8 | 86.4 | 100.0 | 83.3 | 58.4 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 11.5 | 18.0 | 19.6 | 27.1 | 34.8 | 36.2 | 43.7 | 44.4 | 47.8 | 46.4 | 49.4 | 53.0 | 53.4 | 56.4 | 58.0 | 59.3 | 63.6 | 72.3 | 72.9 | 70.8 | 73.8 | 78.3 | 74.8 | 73.3 | 71.9 | 74.8 | 77.6 | 73.1 | 79.6 | 78.9 | 76.7 | 80.0 | 81.4 | 78.6 | 80.2 | 81.0 | 79.7 | 71.7 | 75.0 | 100.0 | 100.0 | 58.7 | 38.6 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in the outcome measure. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 54.7 | 50.7 | 52.7 | 54.9 | 56.3 | 55.5 | 58.2 | 54.5 | 54.7 | 61.6 | 64.2 | 64.3 | 60.8 | 65.7 | 64.9 | 57.1 | 62.5 | 100.0 | 52.2 | 35.4 |
Participants Who Completed 015K-CL-RAJ4 | 54.5 | 58.1 | 61.6 | 63.7 | 65.1 | 66.5 | 68.5 | 68.6 | 69.6 | 68.9 | 69.5 | 71.4 | 68.9 | 67.6 | 68.4 | 73.3 | 63.6 | 100.0 | 65.8 | 40.4 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in the outcome measure. (NCT01638013)
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 7.0 | 11.5 | 13.1 | 13.7 | 21.7 | 21.9 | 23.3 | 27.3 | 29.0 | 30.9 | 30.8 | 28.6 | 36.8 | 38.0 | 39.5 | 42.7 | 43.9 | 51.5 | 50.4 | 46.2 | 54.0 | 56.7 | 53.8 | 55.2 | 56.6 | 54.5 | 59.8 | 52.4 | 58.2 | 56.8 | 57.8 | 56.2 | 60.5 | 54.8 | 58.0 | 54.4 | 59.4 | 50.9 | 52.5 | 50.0 | 100.0 | 41.3 | 20.8 |
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 24.6 | 27.4 | 28.4 | 31.6 | 32.5 | 30.4 | 37.7 | 35.6 | 37.6 | 39.6 | 40.5 | 41.4 | 41.2 | 42.9 | 51.4 | 42.9 | 25.0 | 0.0 | 36.0 | 13.8 |
Participants Who Completed 015K-CL-RAJ4 | 32.6 | 31.4 | 37.1 | 40.9 | 42.8 | 41.6 | 43.3 | 42.3 | 42.0 | 42.7 | 38.0 | 44.0 | 45.2 | 42.5 | 44.7 | 45.7 | 50.0 | 100.0 | 43.4 | 24.7 |
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT01638013)
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 4.0 | 5.0 | 6.0 | 5.5 | 6.1 | 8.7 | 10.0 | 13.4 | 15.2 | 16.2 | 16.9 | 12.5 | 16.6 | 18.4 | 14.0 | 21.3 | 21.4 | 24.1 | 25.6 | 24.6 | 28.6 | 27.5 | 24.4 | 28.4 | 27.2 | 33.3 | 30.8 | 33.7 | 37.8 | 37.9 | 31.1 | 35.6 | 32.6 | 38.1 | 33.3 | 32.9 | 34.4 | 28.3 | 22.5 | 31.3 | 0.0 | 23.9 | 13.9 |
ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 80.3 | 80.7 | 84.5 | 82.4 | 82.7 | 81.7 | 84.2 | 80.0 | 83.2 | 79.3 | 83.1 | 80.2 | 84.5 | 90.0 | 73.0 | 81.0 | 62.5 | 100.0 | 74.6 | 67.7 |
Participants Who Completed 015K-CL-RAJ4 | 85.7 | 85.3 | 88.8 | 91.1 | 88.8 | 88.5 | 90.3 | 89.6 | 90.2 | 90.6 | 90.6 | 90.9 | 91.9 | 91.5 | 90.8 | 93.5 | 95.5 | 100.0 | 87.4 | 68.5 |
ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 28.5 | 37.0 | 42.2 | 45.7 | 52.0 | 61.2 | 63.2 | 63.6 | 65.2 | 63.1 | 66.3 | 67.9 | 70.6 | 74.2 | 73.2 | 76.7 | 74.3 | 77.4 | 75.2 | 76.9 | 77.8 | 81.7 | 77.3 | 77.6 | 80.7 | 80.2 | 82.2 | 78.8 | 80.6 | 76.8 | 77.8 | 74.4 | 79.1 | 73.8 | 75.3 | 78.5 | 79.7 | 75.5 | 65.0 | 81.3 | 100.0 | 64.2 | 53.5 |
ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 62.8 | 60.1 | 63.8 | 65.9 | 67.3 | 64.4 | 66.1 | 63.9 | 64.2 | 64.6 | 67.6 | 72.4 | 68.0 | 75.7 | 70.3 | 71.4 | 62.5 | 100.0 | 59.8 | 41.5 |
Participants Who Completed 015K-CL-RAJ4 | 67.5 | 67.4 | 73.1 | 74.5 | 75.7 | 77.5 | 79.1 | 75.1 | 77.5 | 77.9 | 76.1 | 78.3 | 77.2 | 74.5 | 78.9 | 76.1 | 77.3 | 100.0 | 73.8 | 47.2 |
ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 8.5 | 9.5 | 14.1 | 23.1 | 28.3 | 30.1 | 34.7 | 36.9 | 40.8 | 38.0 | 41.3 | 42.9 | 46.6 | 48.5 | 49.0 | 55.3 | 52.1 | 54.7 | 56.4 | 56.2 | 59.5 | 63.3 | 62.2 | 64.7 | 61.4 | 63.1 | 68.2 | 61.5 | 64.3 | 61.1 | 62.2 | 63.3 | 65.1 | 61.9 | 63.0 | 59.5 | 62.5 | 60.4 | 50.0 | 68.8 | 100.0 | 45.8 | 31.7 |
ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of Participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 58.3 | 58.3 | 60.9 | 64.4 | 62.2 | 62.8 | 65.0 | 61.7 | 61.8 | 63.4 | 64.9 | 71.6 | 66.0 | 70.0 | 67.6 | 61.9 | 62.5 | 100.0 | 58.9 | 38.5 |
Participants Who Completed 015K-CL-RAJ4 | 65.3 | 66.4 | 71.1 | 72.2 | 74.1 | 74.7 | 76.8 | 73.7 | 74.6 | 75.3 | 75.6 | 75.4 | 77.2 | 72.6 | 76.3 | 73.9 | 72.7 | 100.0 | 72.3 | 46.1 |
ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of Participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 8.0 | 9.0 | 13.1 | 21.6 | 24.2 | 29.1 | 31.1 | 33.2 | 38.6 | 34.6 | 38.4 | 41.1 | 44.8 | 45.4 | 45.9 | 51.3 | 49.3 | 54.7 | 54.9 | 55.4 | 58.7 | 60.8 | 61.3 | 63.8 | 57.9 | 60.4 | 63.6 | 58.7 | 63.3 | 56.8 | 57.8 | 55.6 | 59.3 | 58.3 | 60.5 | 55.7 | 54.7 | 56.6 | 45.0 | 62.5 | 100.0 | 45.8 | 28.7 |
ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 42.2 | 40.4 | 40.6 | 42.4 | 41.3 | 45.5 | 42.6 | 44.4 | 43.9 | 47.6 | 48.6 | 48.3 | 48.5 | 48.6 | 48.6 | 47.6 | 50.0 | 100.0 | 39.7 | 24.6 |
Participants Who Completed 015K-CL-RAJ4 | 45.9 | 46.1 | 51.5 | 50.9 | 54.8 | 53.7 | 56.7 | 55.3 | 56.0 | 57.3 | 52.6 | 55.4 | 52.9 | 48.1 | 52.6 | 58.7 | 59.1 | 100.0 | 53.4 | 33.7 |
ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 3.5 | 4.5 | 6.0 | 9.0 | 12.1 | 12.2 | 13.2 | 17.1 | 18.5 | 17.9 | 22.7 | 22.6 | 23.9 | 25.2 | 24.2 | 26.7 | 29.3 | 29.9 | 35.3 | 35.4 | 36.5 | 36.7 | 39.5 | 39.7 | 42.1 | 44.1 | 46.7 | 41.3 | 43.9 | 44.2 | 46.7 | 43.3 | 44.2 | 41.7 | 40.7 | 46.8 | 50.0 | 41.5 | 27.5 | 50.0 | 0.0 | 29.9 | 19.8 |
ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 36.8 | 36.2 | 36.2 | 38.0 | 38.3 | 41.4 | 38.8 | 40.0 | 39.9 | 42.7 | 43.9 | 39.7 | 42.3 | 47.1 | 45.9 | 47.6 | 50.0 | 100.0 | 38.4 | 20.0 |
Participants Who Completed 015K-CL-RAJ4 | 41.3 | 42.9 | 47.0 | 44.6 | 50.1 | 50.8 | 51.9 | 51.5 | 52.8 | 52.1 | 49.3 | 53.1 | 49.3 | 46.2 | 50.0 | 56.5 | 59.1 | 100.0 | 50.7 | 32.6 |
ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 2.5 | 4.0 | 5.5 | 7.0 | 10.1 | 9.7 | 11.1 | 12.8 | 16.3 | 17.3 | 22.1 | 20.2 | 19.6 | 22.1 | 21.0 | 25.3 | 27.1 | 28.5 | 34.6 | 32.3 | 34.1 | 34.2 | 37.8 | 37.1 | 36.8 | 42.3 | 44.9 | 42.3 | 43.9 | 41.1 | 42.2 | 40.0 | 38.4 | 39.3 | 35.8 | 43.0 | 43.8 | 35.8 | 27.5 | 37.5 | 0.0 | 28.4 | 17.8 |
"ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.~EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT." (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 12 | Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ3 | 82.5 | 81.2 | 85.5 | 83.9 | 83.7 | 81.7 | 86.3 | 80.6 | 85.0 | 79.3 | 84.5 | 81.0 | 85.6 | 90.0 | 75.7 | 81.0 | 62.5 | 100.0 | 74.6 | 69.2 |
Participants Who Completed 015K-CL-RAJ4 | 86.2 | 85.0 | 89.1 | 91.9 | 90.2 | 89.0 | 90.0 | 89.9 | 90.6 | 91.0 | 91.1 | 91.4 | 91.9 | 93.4 | 93.4 | 93.5 | 95.5 | 100.0 | 87.9 | 68.5 |
"ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.~EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT." (NCT01638013)
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 0 | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 | Week 324 | Week 336 | Week 348 | Week 360 | Week 372 | EOT | EOS | |
Participants Who Completed 015K-CL-RAJ1 | 29.5 | 37.0 | 42.2 | 47.2 | 55.1 | 59.7 | 63.7 | 63.6 | 65.2 | 62.6 | 68.0 | 70.2 | 73.0 | 76.1 | 73.2 | 77.3 | 76.4 | 78.1 | 77.4 | 78.5 | 79.4 | 83.3 | 79.0 | 77.6 | 79.8 | 82.9 | 83.2 | 80.8 | 80.6 | 78.9 | 78.9 | 75.6 | 81.4 | 76.2 | 76.5 | 81.0 | 82.8 | 75.5 | 70.0 | 87.5 | 100.0 | 64.7 | 52.5 |
Higher CRP indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | mg/dL (Mean) |
---|---|
Placebo | -0.001 |
Peficitinib 100 mg | -1.499 |
Peficitinib 150 mg | -1.421 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | -0.51 |
Peficitinib 100 mg | -1.66 |
Peficitinib 150 mg | -2.12 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | -0.51 |
Peficitinib 100 mg | -1.70 |
Peficitinib 150 mg | -2.09 |
Higher ESR indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | mm/h (Mean) |
---|---|
Placebo | -2.42 |
Peficitinib 100 mg | -18.90 |
Peficitinib 150 mg | -22.17 |
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | 0.01 |
Peficitinib 100 mg | -0.22 |
Peficitinib 150 mg | -0.37 |
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 28/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | 3.37 |
Peficitinib 100 mg | 1.62 |
Peficitinib 150 mg | 1.03 |
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 52/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | 6.27 |
Peficitinib 100 mg | 2.12 |
Peficitinib 150 mg | 1.54 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | percent overall work impairment (Mean) |
---|---|
Placebo | -2.75 |
Peficitinib 100 mg | -11.58 |
Peficitinib 150 mg | -16.91 |
The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | -11.88 |
Peficitinib 100 mg | -28.83 |
Peficitinib 150 mg | -35.96 |
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | -4.90 |
Peficitinib 100 mg | -15.66 |
Peficitinib 150 mg | -19.57 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | 1.07 |
Peficitinib 100 mg | 3.28 |
Peficitinib 150 mg | 2.50 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | -0.09 |
Peficitinib 100 mg | 2.30 |
Peficitinib 150 mg | 3.90 |
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | -7.11 |
Peficitinib 100 mg | -21.09 |
Peficitinib 150 mg | -26.57 |
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | -6.64 |
Peficitinib 100 mg | -21.09 |
Peficitinib 150 mg | -26.87 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | units on a scale (Mean) |
---|---|
Placebo | 0.57 |
Peficitinib 100 mg | 6.60 |
Peficitinib 150 mg | 9.02 |
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | swollen joint count (Mean) |
---|---|
Placebo | -2.2 |
Peficitinib 100 mg | -5.9 |
Peficitinib 150 mg | -7.6 |
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | tender joint count (Mean) |
---|---|
Placebo | -2.1 |
Peficitinib 100 mg | -6.9 |
Peficitinib 150 mg | -9.1 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | percent work time missed (Mean) |
---|---|
Placebo | -0.82 |
Peficitinib 100 mg | 0.36 |
Peficitinib 150 mg | -1.46 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | percent activity impairment (Mean) |
---|---|
Placebo | -2.50 |
Peficitinib 100 mg | -13.98 |
Peficitinib 150 mg | -19.35 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | percent work impairment (Mean) |
---|---|
Placebo | -2.42 |
Peficitinib 100 mg | -11.71 |
Peficitinib 150 mg | -15.96 |
Participants who discontinued due to lack of efficacy have been reported. (NCT02305849)
Timeframe: Up to week 52
Intervention | Participants (Count of Participants) |
---|---|
Peficitinib 100 mg | 10 |
Peficitinib 150 mg | 6 |
Placebo / Peficitinib 100 mg | 3 |
Placebo / Peficitinib 150 mg | 9 |
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 0.6 |
Peficitinib 100 mg | 5.8 |
Peficitinib 150 mg | 9.9 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 7.7 |
Peficitinib 100 mg | 31.4 |
Peficitinib 150 mg | 35.1 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 12.4 |
Peficitinib 100 mg | 47.1 |
Peficitinib 150 mg | 57.9 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 2.4 |
Peficitinib 100 mg | 12.8 |
Peficitinib 150 mg | 19.3 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 4.7 |
Peficitinib 100 mg | 25.0 |
Peficitinib 150 mg | 36.3 |
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 0.6 |
Peficitinib 100 mg | 7.0 |
Peficitinib 150 mg | 14.0 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 32.0 |
Peficitinib 100 mg | 74.4 |
Peficitinib 150 mg | 78.9 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in the outcome measure. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 4.1 |
Peficitinib 100 mg | 23.8 |
Peficitinib 150 mg | 34.5 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 10.1 |
Peficitinib 100 mg | 43.0 |
Peficitinib 150 mg | 55.6 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT02305849)
Timeframe: Week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 35.5 |
Peficitinib 100 mg | 77.9 |
Peficitinib 150 mg | 84.8 |
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 7.6 |
Peficitinib 100 mg | 29.9 |
Peficitinib 150 mg | 46.0 |
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/ET
Intervention | percentage of participants (Number) |
---|---|
Placebo | 2.4 |
Peficitinib 100 mg | 12.1 |
Peficitinib 150 mg | 23.6 |
ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline and week 12/Early termination (ET)
Intervention | percentage of participants (Number) |
---|---|
Placebo | 21.8 |
Peficitinib 100 mg | 58.6 |
Peficitinib 150 mg | 64.4 |
Higher CRP indicates greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | mg/dL (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -1.055 | -1.207 | -1.532 | -1.666 | -1.660 | -1.774 | -1.803 | -1.844 | -1.832 | -1.833 | -1.815 | -1.771 | -1.841 | -1.545 |
Peficitinib 150 mg | -1.411 | -1.569 | -1.458 | -1.513 | -1.660 | -1.721 | -1.721 | -1.640 | -1.696 | -1.716 | -1.725 | -1.751 | -1.912 | -1.629 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -1.11 | -1.48 | -1.72 | -2.01 | -2.21 | -2.40 | -2.42 | -2.50 | -2.55 | -2.66 | -2.65 | -2.62 | -2.67 | -2.43 |
Peficitinib 150 mg | -1.39 | -1.87 | -2.15 | -2.40 | -2.53 | -2.71 | -2.70 | -2.77 | -2.83 | -2.86 | -2.88 | -2.92 | -2.96 | -2.76 |
Placebo / Peficitinib 100 mg at Week 12 | -0.28 | -0.21 | 0.24 | -1.11 | -1.69 | -2.01 | -2.24 | -2.49 | -2.49 | -2.66 | -2.68 | -2.86 | -2.80 | -2.61 |
Placebo / Peficitinib 100 mg at Week 28 | -0.82 | -0.94 | -1.34 | -1.37 | -1.38 | -1.41 | -1.53 | -2.18 | -2.22 | -2.62 | -2.63 | -2.66 | -2.70 | -2.72 |
Placebo / Peficitinib 150 mg at Week 12 | -0.30 | -0.10 | 0.27 | -1.37 | -1.76 | -2.26 | -2.51 | -2.72 | -2.70 | -2.72 | -2.72 | -2.90 | -2.74 | -2.52 |
Placebo / Peficitinib 150 mg at Week 28 | -0.74 | -0.90 | -1.20 | -1.31 | -1.48 | -1.64 | -1.71 | -2.47 | -2.57 | -2.73 | -2.87 | -2.96 | -2.89 | -2.87 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -1.07 | -1.47 | -1.68 | -1.98 | -2.23 | -2.43 | -2.47 | -2.56 | -2.59 | -2.70 | -2.71 | -2.64 | -2.70 | -2.47 |
Peficitinib 150 mg | -1.37 | -1.88 | -2.18 | -2.46 | -2.60 | -2.78 | -2.79 | -2.87 | -2.91 | -2.96 | -3.00 | -3.01 | -3.07 | -2.86 |
Placebo / Peficitinib 100 mg at Week 12 | -0.26 | -0.24 | 0.24 | -1.01 | -1.61 | -1.94 | -2.11 | -2.39 | -2.45 | -2.60 | -2.63 | -2.80 | -2.77 | -2.60 |
Placebo / Peficitinib 100 mg at Week 28 | -0.87 | -1.00 | -1.40 | -1.47 | -1.45 | -1.47 | -1.63 | -2.27 | -2.38 | -2.71 | -2.74 | -2.72 | -2.79 | -2.80 |
Placebo / Peficitinib 150 mg at Week 12 | -0.26 | -0.12 | 0.25 | -1.38 | -1.78 | -2.24 | -2.48 | -2.68 | -2.71 | -2.78 | -2.76 | -2.88 | -2.78 | -2.56 |
Placebo / Peficitinib 150 mg at Week 28 | -0.67 | -0.85 | -1.10 | -1.21 | -1.37 | -1.56 | -1.62 | -2.37 | -2.54 | -2.68 | -2.78 | -2.93 | -2.85 | -2.82 |
The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity. (NCT02305849)
Timeframe: Baseline and weeks 28/ET and 52/ET
Intervention | units on a scale (Mean) | |
---|---|---|
Week 28/ET | Week 52/ET | |
Peficitinib 100 mg | 0.63 | 0.82 |
Peficitinib 150 mg | 0.18 | 0.32 |
Placebo | 1.35 | 2.52 |
Higher ESR indicates greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | mm/h (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -11.09 | -14.96 | -19.14 | -21.42 | -23.22 | -25.35 | -26.03 | -26.92 | -25.95 | -25.86 | -27.13 | -25.63 | -26.86 | -24.00 |
Peficitinib 150 mg | -16.59 | -21.10 | -22.92 | -24.29 | -26.20 | -27.36 | -27.88 | -27.21 | -27.25 | -27.74 | -27.99 | -27.83 | -29.12 | -26.11 |
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -0.08 | -0.18 | -0.23 | -0.30 | -0.33 | -0.36 | -0.36 | -0.37 | -0.39 | -0.42 | -0.45 | -0.44 | -0.43 | -0.36 |
Peficitinib 150 mg | -0.21 | -0.32 | -0.38 | -0.41 | -0.47 | -0.48 | -0.51 | -0.53 | -0.53 | -0.56 | -0.54 | -0.56 | -0.56 | -0.51 |
JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity. (NCT02305849)
Timeframe: Baseline and weeks 28/ET and 52/ET
Intervention | units on a scale (Mean) | |
---|---|---|
Week 28/ET | Week 52/ET | |
Peficitinib 100 mg | 0.99 | 1.30 |
Peficitinib 150 mg | 0.82 | 1.19 |
Placebo | 1.90 | 3.55 |
The investigator assessed the participants disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -18.36 | -25.79 | -29.07 | -33.60 | -36.18 | -37.13 | -38.72 | -40.04 | -39.35 | -41.04 | -41.47 | -41.55 | -41.49 | -38.41 |
Peficitinib 150 mg | -22.94 | -31.54 | -36.55 | -38.86 | -41.44 | -43.67 | -42.43 | -43.96 | -44.37 | -44.32 | -46.00 | -45.84 | -45.46 | -43.33 |
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -11.02 | -14.60 | -15.94 | -18.75 | -20.24 | -21.62 | -21.89 | -22.61 | -22.89 | -23.55 | -23.55 | -23.23 | -23.67 | -21.48 |
Peficitinib 150 mg | -13.79 | -18.36 | -20.08 | -22.21 | -23.03 | -24.68 | -24.57 | -25.38 | -25.55 | -26.14 | -26.44 | -26.50 | -26.63 | -24.72 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | EOT | |
Peficitinib 100 mg | 1.45 | 2.72 | 3.44 | 3.06 | 2.62 | 2.21 |
Peficitinib 150 mg | 1.33 | 2.44 | 2.67 | 3.12 | 1.85 | 1.67 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | EOT | |
Peficitinib 100 mg | 3.84 | 4.92 | 6.68 | 9.89 | 11.27 | 9.92 |
Peficitinib 150 mg | 5.77 | 7.91 | 9.32 | 12.44 | 12.45 | 11.51 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Intervention | units on a scale (Mean) | |||||
---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | EOT | |
Peficitinib 100 mg | 1.41 | 2.50 | 2.32 | 4.06 | 4.30 | 3.49 |
Peficitinib 150 mg | 1.70 | 3.30 | 3.92 | 4.81 | 7.17 | 5.88 |
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -13.80 | -19.11 | -21.59 | -25.20 | -26.94 | -29.00 | -30.04 | -31.92 | -32.38 | -32.80 | -33.49 | -33.69 | -33.18 | -29.34 |
Peficitinib 150 mg | -17.59 | -24.97 | -27.40 | -30.14 | -31.20 | -32.79 | -34.25 | -33.46 | -34.01 | -34.24 | -35.31 | -35.33 | -36.16 | -34.05 |
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -12.94 | -19.10 | -21.27 | -24.03 | -25.57 | -27.34 | -28.54 | -31.32 | -31.95 | -32.17 | -32.73 | -33.60 | -33.34 | -28.94 |
Peficitinib 150 mg | -16.18 | -24.98 | -27.81 | -28.42 | -30.63 | -32.72 | -34.18 | -33.74 | -32.66 | -34.07 | -34.88 | -35.07 | -35.00 | -32.68 |
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | swollen joint count (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -4.3 | -5.6 | -6.0 | -7.5 | -8.1 | -8.8 | -8.8 | -9.0 | -9.0 | -9.4 | -9.4 | -9.2 | -9.6 | -8.8 |
Peficitinib 150 mg | -5.3 | -7.1 | -7.8 | -8.9 | -9.2 | -9.9 | -9.8 | -10.3 | -10.5 | -10.7 | -10.8 | -11.0 | -11.0 | -10.3 |
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | tender joint count (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | -5.1 | -6.8 | -7.1 | -8.1 | -9.1 | -9.9 | -9.6 | -9.7 | -10.4 | -10.8 | -10.6 | -10.5 | -10.8 | -9.8 |
Peficitinib 150 mg | -6.3 | -8.3 | -9.3 | -10.5 | -10.8 | -11.3 | -11.4 | -12.1 | -11.8 | -11.9 | -12.1 | -12.1 | -11.9 | -11.2 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Intervention | percent activity impairment (Mean) | |||||
---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | EOT | |
Peficitinib 100 mg | -9.23 | -13.07 | -13.71 | -22.17 | -24.10 | -21.58 |
Peficitinib 150 mg | -10.65 | -17.44 | -19.88 | -26.99 | -26.71 | -23.47 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculates as Q5/10. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Intervention | percent work impairment (Mean) | |||||
---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | EOT | |
Peficitinib 100 mg | -10.00 | -12.50 | -11.97 | -20.00 | -22.97 | -17.35 |
Peficitinib 150 mg | -6.56 | -13.98 | -16.29 | -21.40 | -22.41 | -20.43 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Intervention | percent overall work impairment (Mean) | |||||
---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | EOT | |
Peficitinib 100 mg | -10.61 | -13.13 | -12.15 | -20.76 | -22.48 | -17.43 |
Peficitinib 150 mg | -7.51 | -14.67 | -17.15 | -22.49 | -23.40 | -21.59 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT
Intervention | percent work time missed (Mean) | |||||
---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | EOT | |
Peficitinib 100 mg | -0.90 | -1.48 | -0.70 | -0.58 | -1.93 | -1.76 |
Peficitinib 150 mg | 0.02 | -1.73 | -1.97 | -3.49 | -1.66 | -1.66 |
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE (NCT02305849)
Timeframe: Week 12 to week 28
Intervention | Participants (Count of Participants) | |||||||
---|---|---|---|---|---|---|---|---|
TEAEs | Drug-related TEAEs | TEAEs leading to death | Serious TEAEs | Drug-related serious TEAEs | ≥ Grade 3 TEAEs | TEAEs leading to permanent discontinuation | Drug-Related TEAE leading to permanent dicont. | |
Peficitinib 100 mg | 95 | 63 | 0 | 5 | 3 | 7 | 4 | 3 |
Peficitinib 150 mg | 104 | 72 | 0 | 3 | 1 | 6 | 1 | 1 |
Placebo | 50 | 27 | 0 | 2 | 2 | 5 | 4 | 3 |
Placebo / Peficitinib 100 mg at Week 12 | 21 | 16 | 0 | 0 | 0 | 1 | 0 | 0 |
Placebo / Peficitinib 150 mg at Week 12 | 25 | 11 | 0 | 0 | 0 | 1 | 0 | 0 |
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02305849)
Timeframe: Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study
Intervention | Participants (Count of Participants) | ||||||
---|---|---|---|---|---|---|---|
TEAEs | Drug-related TEAEs | TEAEs leading to death | Serious TEAEs | Drug-related serious TEAEs | ≥ Grade 3 TEAEs | TEAEs leading to permanent discontinuation | |
Peficitinib 100 mg | 114 | 72 | 0 | 10 | 4 | 15 | 4 |
Peficitinib 150 mg | 112 | 74 | 0 | 8 | 5 | 15 | 6 |
Placebo / Peficitinib 100 mg at Week 12 | 22 | 14 | 0 | 2 | 2 | 2 | 3 |
Placebo / Peficitinib 100 mg at Week 28 | 25 | 17 | 1 | 1 | 0 | 2 | 2 |
Placebo / Peficitinib 150 mg at Week 12 | 27 | 18 | 0 | 1 | 1 | 2 | 2 |
Placebo / Peficitinib 150 mg at Week 28 | 26 | 17 | 0 | 1 | 1 | 2 | 0 |
TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02305849)
Timeframe: Week 0 to week 12
Intervention | Participants (Count of Participants) | |||||||
---|---|---|---|---|---|---|---|---|
TEAEs | Drug-related TEAEs | TEAEs leading to death | Serious TEAEs | Drug-related serious TEAEs | ≥ Grade 3 TEAEs | TEAEs leading to permanent discontinuation | Drug-Related AE leading to permanent discont. | |
Peficitinib 100 mg | 89 | 57 | 0 | 5 | 3 | 9 | 5 | 3 |
Peficitinib 150 mg | 104 | 80 | 0 | 3 | 3 | 16 | 5 | 5 |
Placebo | 84 | 47 | 0 | 4 | 2 | 8 | 7 | 6 |
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 1.2 | 1.2 | 6.0 | 9.0 | 11.0 | 11.8 | 14.6 | 17.2 | 17.0 | 19.1 | 16.1 | 17.6 | 21.4 | 19.2 |
Peficitinib 150 mg | 1.2 | 3.6 | 10.2 | 12.1 | 14.1 | 18.1 | 20.1 | 25.8 | 27.7 | 20.9 | 20.3 | 21.2 | 26.5 | 23.4 |
mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT02305849)
Timeframe: Baseline and week 28/ET and 52/ET
Intervention | percentage of participants (Number) | |
---|---|---|
Week 28/ET | Week 52/ET | |
Peficitinib 100 mg | 67.1 | 64.0 |
Peficitinib 150 mg | 72.6 | 68.9 |
Placebo | 45.8 | 42.5 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 11.2 | 19.0 | 31.0 | 39.2 | 45.7 | 51.6 | 51.9 | 54.1 | 53.6 | 59.9 | 57.0 | 56.1 | 60.0 | 56.4 |
Peficitinib 150 mg | 14.7 | 21.7 | 36.1 | 43.0 | 52.1 | 56.9 | 52.8 | 52.9 | 53.5 | 58.8 | 55.6 | 60.3 | 62.6 | 57.9 |
Placebo / Peficitinib 100 mg at Week 12 | 0.0 | 0.0 | 0.0 | 8.1 | 21.6 | 27.8 | 30.6 | 44.4 | 50.0 | 42.9 | 50.0 | 54.5 | 54.5 | 54.1 |
Placebo / Peficitinib 100 mg at Week 28 | 15.4 | 10.3 | 20.5 | 20.5 | 17.9 | 20.5 | 25.6 | 30.8 | 35.1 | 61.1 | 55.6 | 62.9 | 55.9 | 56.4 |
Placebo / Peficitinib 150 mg at Week 12 | 0.0 | 0.0 | 0.0 | 13.5 | 16.2 | 33.3 | 38.9 | 50.0 | 48.6 | 50.0 | 42.4 | 54.5 | 39.4 | 34.2 |
Placebo / Peficitinib 150 mg at Week 28 | 5.9 | 11.8 | 11.8 | 8.8 | 29.4 | 32.4 | 26.5 | 44.1 | 54.5 | 54.5 | 57.6 | 66.7 | 63.6 | 64.7 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 22.4 | 36.3 | 47.0 | 55.4 | 62.2 | 67.1 | 67.7 | 65.6 | 69.3 | 76.3 | 70.5 | 73.6 | 71.7 | 66.9 |
Peficitinib 150 mg | 24.1 | 44.0 | 59.6 | 63.6 | 69.9 | 71.9 | 76.7 | 70.3 | 73.5 | 80.4 | 82.4 | 78.8 | 77.6 | 71.3 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 4.1 | 8.9 | 13.1 | 18.1 | 22.6 | 28.0 | 30.4 | 33.8 | 32.7 | 37.1 | 34.0 | 33.3 | 38.6 | 34.9 |
Peficitinib 150 mg | 5.9 | 12.7 | 19.9 | 24.2 | 33.1 | 31.3 | 32.1 | 41.3 | 40.0 | 36.2 | 37.3 | 40.4 | 42.9 | 38.6 |
Placebo / Peficitinib 100 mg at Week 12 | 0.0 | 0.0 | 0.0 | 0.0 | 5.4 | 5.6 | 11.1 | 22.2 | 13.9 | 20.0 | 17.6 | 21.2 | 27.3 | 24.3 |
Placebo / Peficitinib 100 mg at Week 28 | 2.6 | 2.6 | 5.1 | 10.3 | 7.7 | 12.8 | 12.8 | 15.4 | 13.5 | 22.2 | 25.0 | 34.3 | 26.5 | 25.6 |
Placebo / Peficitinib 150 mg at Week 12 | 0.0 | 0.0 | 0.0 | 10.8 | 10.8 | 27.8 | 22.2 | 30.6 | 37.1 | 35.3 | 24.2 | 39.4 | 36.4 | 31.6 |
Placebo / Peficitinib 150 mg at Week 28 | 0.0 | 2.9 | 5.9 | 2.9 | 5.9 | 5.9 | 8.8 | 26.5 | 24.2 | 30.3 | 30.3 | 36.4 | 39.4 | 41.2 |
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 10.6 | 17.9 | 25.6 | 34.9 | 44.5 | 52.2 | 49.4 | 52.2 | 53.6 | 58.3 | 53.7 | 55.8 | 55.2 | 50.6 |
Peficitinib 150 mg | 12.9 | 29.5 | 37.3 | 44.2 | 48.5 | 57.5 | 56.0 | 56.1 | 56.8 | 60.5 | 60.8 | 62.9 | 60.5 | 57.3 |
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 1.2 | 3.0 | 7.1 | 14.5 | 18.3 | 20.5 | 22.2 | 25.5 | 24.2 | 31.6 | 27.5 | 25.7 | 30.3 | 28.5 |
Peficitinib 150 mg | 2.4 | 8.4 | 14.5 | 18.2 | 20.9 | 22.5 | 23.3 | 28.4 | 32.9 | 28.8 | 30.1 | 32.5 | 39.5 | 35.1 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 55.9 | 72.0 | 75.0 | 80.7 | 82.3 | 87.6 | 88.0 | 90.4 | 94.1 | 92.7 | 96.6 | 94.6 | 93.8 | 86.0 |
Peficitinib 150 mg | 68.2 | 76.5 | 80.1 | 87.9 | 92.0 | 91.9 | 91.2 | 92.9 | 94.8 | 94.1 | 94.1 | 95.4 | 94.6 | 90.6 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 19.4 | 30.4 | 42.9 | 51.8 | 59.1 | 65.2 | 63.3 | 63.1 | 67.3 | 73.7 | 65.8 | 71.6 | 69.0 | 64.5 |
Peficitinib 150 mg | 21.8 | 41.0 | 57.2 | 60.0 | 68.1 | 70.0 | 74.2 | 69.0 | 72.9 | 79.1 | 81.0 | 78.1 | 76.9 | 70.8 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good response have been reported in this outcome measure. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 7.6 | 16.1 | 24.4 | 34.3 | 43.3 | 51.6 | 48.1 | 51.0 | 53.6 | 57.6 | 52.4 | 53.7 | 53.8 | 49.4 |
Peficitinib 150 mg | 12.4 | 28.3 | 35.5 | 43.6 | 46.0 | 55.6 | 54.1 | 54.8 | 54.8 | 58.6 | 59.5 | 60.9 | 59.2 | 56.1 |
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. Percentage of participants with good or moderate response have been reported in this outcome measure. (NCT02305849)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 67.1 | 73.8 | 78.6 | 84.3 | 86.6 | 89.4 | 91.1 | 93.0 | 94.8 | 92.8 | 95.3 | 95.3 | 95.2 | 88.4 |
Peficitinib 150 mg | 77.1 | 80.1 | 85.5 | 89.1 | 91.4 | 95.6 | 93.7 | 94.2 | 95.5 | 96.1 | 94.1 | 97.4 | 94.6 | 92.4 |
ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination or week 52. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 38.2 | 51.2 | 59.5 | 70.5 | 74.4 | 74.5 | 79.1 | 79.6 | 78.4 | 80.9 | 79.9 | 83.8 | 84.8 | 76.4 |
Peficitinib 150 mg | 48.2 | 62.0 | 66.3 | 77.0 | 79.8 | 85.0 | 83.0 | 85.2 | 86.5 | 86.9 | 86.9 | 89.4 | 87.1 | 81.0 |
Placebo / Peficitinib 100 mg at Week 12 | 8.1 | 10.8 | 0.0 | 43.2 | 59.5 | 63.9 | 72.2 | 77.8 | 80.6 | 80.0 | 76.5 | 81.8 | 75.8 | 73.0 |
Placebo / Peficitinib 100 mg at Week 28 | 38.5 | 33.3 | 51.3 | 64.1 | 61.5 | 59.0 | 64.1 | 84.6 | 78.4 | 88.9 | 88.9 | 85.7 | 91.2 | 92.3 |
Placebo / Peficitinib 150 mg at Week 12 | 2.7 | 0.0 | 0.0 | 51.4 | 67.6 | 80.6 | 83.3 | 86.1 | 85.7 | 88.2 | 90.9 | 90.9 | 90.9 | 78.9 |
Placebo / Peficitinib 150 mg at Week 28 | 14.7 | 29.4 | 38.2 | 58.8 | 61.8 | 52.9 | 64.7 | 76.5 | 75.8 | 78.8 | 87.9 | 90.9 | 90.9 | 91.2 |
ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 10.0 | 19.6 | 29.8 | 46.4 | 51.2 | 56.5 | 53.8 | 59.2 | 55.6 | 61.8 | 57.7 | 60.8 | 66.9 | 60.3 |
Peficitinib 150 mg | 15.9 | 33.1 | 48.2 | 53.9 | 54.6 | 60.6 | 63.5 | 65.8 | 67.7 | 68.0 | 71.2 | 64.9 | 68.0 | 62.6 |
Placebo / Peficitinib 100 mg at Week 12 | 2.7 | 2.7 | 0.0 | 13.5 | 35.1 | 47.2 | 50.0 | 52.8 | 58.3 | 48.6 | 52.9 | 60.6 | 63.6 | 62.2 |
Placebo / Peficitinib 100 mg at Week 28 | 10.3 | 12.8 | 23.1 | 38.5 | 35.9 | 33.3 | 28.2 | 56.4 | 64.9 | 66.7 | 72.2 | 71.4 | 67.6 | 69.2 |
Placebo / Peficitinib 150 mg at Week 12 | 0.0 | 0.0 | 0.0 | 21.6 | 37.8 | 52.8 | 69.4 | 61.1 | 71.4 | 67.6 | 72.7 | 69.7 | 63.6 | 55.3 |
Placebo / Peficitinib 150 mg at Week 28 | 0.0 | 2.9 | 5.9 | 8.8 | 29.4 | 29.4 | 23.5 | 52.9 | 60.6 | 66.7 | 63.6 | 66.7 | 69.7 | 70.6 |
ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. (NCT02305849)
Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT
Intervention | percentage of participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Peficitinib 100 mg | 1.2 | 7.7 | 12.5 | 24.1 | 26.2 | 31.7 | 29.1 | 36.3 | 34.0 | 34.9 | 38.3 | 33.8 | 39.3 | 35.1 |
Peficitinib 150 mg | 4.1 | 13.9 | 24.7 | 32.1 | 35.0 | 36.0 | 42.8 | 43.9 | 47.1 | 41.8 | 48.4 | 49.0 | 52.4 | 48.3 |
Placebo / Peficitinib 100 mg at Week 12 | 0.0 | 0.0 | 0.0 | 5.4 | 8.1 | 22.2 | 33.3 | 33.3 | 33.3 | 31.4 | 41.2 | 45.5 | 42.4 | 40.5 |
Placebo / Peficitinib 100 mg at Week 28 | 2.6 | 2.6 | 7.7 | 12.8 | 12.8 | 17.9 | 17.9 | 20.5 | 13.5 | 36.1 | 38.9 | 45.7 | 44.1 | 43.6 |
Placebo / Peficitinib 150 mg at Week 12 | 0.0 | 0.0 | 0.0 | 2.7 | 2.7 | 16.7 | 38.9 | 44.4 | 42.9 | 38.2 | 36.4 | 42.4 | 48.5 | 42.1 |
Placebo / Peficitinib 150 mg at Week 28 | 0.0 | 0.0 | 2.9 | 2.9 | 2.9 | 2.9 | 8.8 | 20.6 | 33.3 | 33.3 | 39.4 | 39.4 | 48.5 | 50.0 |
"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -7.25 |
Peficitinib 100 mg | -14.91 |
Peficitinib 150 mg | -19.20 |
Etanercept | -20.74 |
Higher CRP indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | mg/dL (Mean) |
---|---|
Placebo | 0.022 |
Peficitinib 100 mg | -1.056 |
Peficitinib 150 mg | -1.734 |
Etanercept | -1.207 |
"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -0.62 |
Peficitinib 100 mg | -1.60 |
Peficitinib 150 mg | -2.24 |
Etanercept | -2.51 |
"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -0.64 |
Peficitinib 100 mg | -1.62 |
Peficitinib 150 mg | -2.17 |
Etanercept | -2.42 |
Higher ESR indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | mm/hour (Mean) |
---|---|
Placebo | -1.96 |
Peficitinib 100 mg | -12.96 |
Peficitinib 150 mg | -23.92 |
Etanercept | -20.92 |
The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | 0.03 |
Peficitinib 100 mg | -0.28 |
Peficitinib 150 mg | -0.37 |
Etanercept | -0.39 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Percent iImpairment (Mean) |
---|---|
Placebo | 3.62 |
Peficitinib 100 mg | -12.20 |
Peficitinib 150 mg | -18.68 |
Etanercept | -24.68 |
The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -13.94 |
Peficitinib 100 mg | -27.69 |
Peficitinib 150 mg | -34.65 |
Etanercept | -37.40 |
"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -7.22 |
Peficitinib 100 mg | -16.08 |
Peficitinib 150 mg | -20.93 |
Etanercept | -21.94 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | 0.00 |
Peficitinib 100 mg | 2.70 |
Peficitinib 150 mg | 3.69 |
Etanercept | 3.23 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | 0.17 |
Peficitinib 100 mg | 1.24 |
Peficitinib 150 mg | 7.04 |
Etanercept | 7.16 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | 1.95 |
Peficitinib 100 m | 8.36 |
Peficitinib 150 mg | 8.81 |
Etanercept | 8.53 |
The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -6.64 |
Peficitinib 100 mg | -23.78 |
Peficitinib 150 mg | -30.65 |
Etanercept | -30.82 |
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Units on a Scale (Mean) |
---|---|
Placebo | -7.87 |
Peficitinib 100 mg | -23.74 |
Peficitinib 150 mg | -31.59 |
Etanercept | -32.43 |
"The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Tender Joints (Mean) |
---|---|
Placebo | -3.2 |
Peficitinib 100 mg | -6.0 |
Peficitinib 150 mg | -8.4 |
Etanercept | -8.3 |
"The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Tender Joints (Mean) |
---|---|
Placebo | -4.3 |
Peficitinib 100 mg | -8.2 |
Peficitinib 150 mg | -9.9 |
Etanercept | -10.7 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Percent Work Time (Mean) |
---|---|
Placebo | 6.78 |
Peficitinib 100 mg | -2.14 |
Peficitinib 150 mg | -6.80 |
Etanercept | -5.60 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Percent Impairment (Mean) |
---|---|
Placebo | -4.65 |
Peficitinib 100 mg | -19.61 |
Peficitinib 150 mg | -24.65 |
Etanercept | -26.40 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Percent Impairment (Mean) |
---|---|
Placebo | 4.13 |
Peficitinib 100 mg | -13.04 |
Peficitinib 150 mg | -16.12 |
Etanercept | -24.43 |
The number of participants who withdrew due to lack of efficacy up to week 12 was calculated. (NCT02308163)
Timeframe: Up to week 12
Intervention | Participants (Count of Participants) |
---|---|
Placebo | 7 |
Peficitinib 100 mg | 1 |
Peficitinib 150 mg | 1 |
Etanercept | 1 |
"ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).~Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups." (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 2.0 |
Peficitinib 100 mg | 5.9 |
Peficitinib 150 mg | 5.9 |
Etanercept | 13.5 |
"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups." (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 0.0 |
Peficitinib 100 mg | 8.7 |
Peficitinib 150 mg | 9.9 |
Etanercept | 19.0 |
"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 5.0 |
Peficitinib 100 mg | 24.5 |
Peficitinib 150 mg | 34.7 |
Etanercept | 45.5 |
"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity." (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 11.0 |
Peficitinib 100 mg | 40.2 |
Peficitinib 150 mg | 53.5 |
Etanercept | 68.0 |
"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission." (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 1.0 |
Peficitinib 100 mg | 11.7 |
Peficitinib 150 mg | 17.8 |
Etanercept | 31.7 |
"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity." (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 7.0 |
Peficitinib 100 mg | 19.4 |
Peficitinib 150 mg | 37.6 |
Etanercept | 49.7 |
"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.~Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups." (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 0.0 |
Peficitinib 100 mg | 8.8 |
Peficitinib 150 mg | 8.9 |
Etanercept | 18.5 |
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 9.1 |
Peficitinib 100 mg | 38.6 |
Peficitinib 150 mg | 51.5 |
Etanercept | 65.5 |
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 5.1 |
Peficitinib 100 mg | 18.6 |
Peficitinib 150 mg | 36.6 |
Etanercept | 49.0 |
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 41.4 |
Peficitinib 100 mg | 75.2 |
Peficitinib 150 mg | 92.1 |
Etanercept | 92.5 |
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 37.8 |
Peficitinib 100 mg | 69.6 |
Peficitinib 150 mg | 88.1 |
Etanercept | 90.9 |
"The ACR20 response required that all criteria from (1) to (3) below be met.~Tender joint count (TJC) : ≥ 20% reduction compared with baseline.~Swollen joint count (SJC) : ≥ 20% reduction compared with baseline.~≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline~(3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP)." (NCT02308163)
Timeframe: Baseline and Week 12/early termination (ET)
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 30.7 |
Peficitinib 100 mg | 57.7 |
Peficitinib 150 mg | 74.5 |
Etanercept | 83.5 |
"The ACR50 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 50% reduction compared with baseline.~SJC : ≥ 50% reduction compared with baseline.~≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 8.9 |
Peficitinib 100 mg | 30.8 |
Peficitinib 150 mg | 42.2 |
Etanercept | 52.5 |
"The ACR70 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 70% reduction compared with baseline.~SJC : ≥ 70% reduction compared with baseline.~≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP." (NCT02308163)
Timeframe: Baseline and Week 12/ET
Intervention | Percentage of Participants (Number) |
---|---|
Placebo | 1.0 |
Peficitinib 100 mg | 13.5 |
Peficitinib 150 mg | 27.5 |
Etanercept | 30.5 |
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Units on a Scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -1.89 | -2.27 | -2.49 | -2.61 | -2.73 | -2.79 | -2.90 | -2.94 | -2.91 | -2.99 | -2.97 | -3.03 | -3.04 | -2.80 |
Peficitinib 100 mg | -1.11 | -1.48 | -1.66 | -1.96 | -2.01 | -2.06 | -2.12 | -2.26 | -2.31 | -2.31 | -2.34 | -2.26 | -2.28 | -2.01 |
Peficitinib 150 mg | -1.29 | -1.92 | -2.27 | -2.40 | -2.57 | -2.68 | -2.80 | -2.77 | -2.87 | -2.88 | -2.86 | -2.98 | -2.99 | -2.75 |
Placebo / Peficitinib 100 mg | -0.49 | -0.70 | -0.70 | -1.60 | -1.58 | -1.60 | -1.90 | -1.98 | -2.21 | -2.17 | -2.39 | -2.58 | -2.51 | -2.11 |
Placebo / Peficitinib 150 mg | -0.56 | -0.65 | -0.82 | -1.92 | -2.15 | -2.28 | -2.35 | -2.22 | -2.26 | -2.47 | -2.47 | -2.73 | -2.73 | -2.50 |
"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Units on a Scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -15.73 | -19.31 | -21.21 | -22.08 | -22.92 | -23.30 | -24.09 | -24.25 | -24.30 | -24.87 | -24.54 | -24.96 | -25.17 | -23.52 |
Peficitinib 100 mg | -11.01 | -13.74 | -15.55 | -18.17 | -18.51 | -18.92 | -18.97 | -20.52 | -20.03 | -20.41 | -20.34 | -20.11 | -20.05 | -17.82 |
Peficitinib 150 mg | -11.42 | -17.06 | -19.81 | -20.06 | -21.55 | -22.28 | -23.38 | -23.30 | -23.58 | -23.76 | -23.84 | -24.50 | -24.93 | -23.12 |
Placebo / Peficitinib 100 mg | -5.61 | -7.29 | -7.52 | -14.40 | -15.08 | -15.71 | -16.74 | -16.46 | -19.48 | -19.00 | -21.34 | -21.58 | -21.44 | -17.96 |
Placebo / Peficitinib 150 mg | -7.28 | -8.35 | -10.04 | -17.72 | -19.31 | -20.93 | -21.48 | -20.17 | -20.83 | -21.86 | -22.00 | -23.20 | -23.67 | -21.39 |
Higher CRP indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | mg/dL (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -1.360 | -1.337 | -1.205 | -1.383 | -1.525 | -1.473 | -1.611 | -1.593 | -1.467 | -1.594 | -1.627 | -1.611 | -1.595 | -1.326 |
Peficitinib 100 mg | -0.817 | -0.967 | -1.045 | -1.083 | -0.964 | -1.225 | -1.323 | -1.200 | -1.310 | -1.199 | -1.202 | -0.964 | -1.138 | -0.949 |
Peficitinib 150 mg | -1.359 | -1.664 | -1.810 | -1.849 | -1.819 | -1.824 | -1.904 | -1.979 | -2.043 | -2.019 | -1.978 | -1.833 | -2.068 | -1.832 |
Placebo / Peficitinib 100 mg | 0.013 | 0.198 | 0.026 | -0.802 | -0.581 | -0.434 | -1.013 | -1.239 | -1.084 | -1.325 | -1.292 | -1.610 | -1.566 | -0.797 |
Placebo / Peficitinib 150 mg | 0.073 | -0.076 | -0.142 | -1.180 | -1.294 | -1.318 | -1.266 | -0.975 | -1.192 | -1.232 | -1.225 | -1.407 | -1.534 | -0.987 |
"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Units on a Scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -1.90 | -2.33 | -2.58 | -2.68 | -2.76 | -2.86 | -2.97 | -3.01 | -3.00 | -3.10 | -3.05 | -3.16 | -3.10 | -2.86 |
Peficitinib 100 mg | -1.13 | -1.50 | -1.65 | -1.95 | -2.06 | -2.11 | -2.14 | -2.28 | -2.38 | -2.38 | -2.40 | -2.32 | -2.35 | -2.06 |
Peficitinib 150 mg | -1.26 | -1.96 | -2.35 | -2.50 | -2.65 | -2.79 | -2.87 | -2.88 | -3.00 | -3.02 | -3.02 | -3.09 | -3.06 | -2.81 |
Placebo / Peficitinib 100 mg | -0.46 | -0.68 | -0.66 | -1.53 | -1.57 | -1.60 | -1.94 | -1.98 | -2.18 | -2.12 | -2.39 | -2.67 | -2.45 | -2.06 |
Placebo / Peficitinib 150 mg | -0.63 | -0.57 | -0.80 | -1.84 | -2.15 | -2.25 | -2.31 | -2.26 | -2.28 | -2.49 | -2.55 | -2.79 | -2.67 | -2.44 |
Higher ESR indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | mm/hour (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -19.20 | -20.88 | -21.74 | -22.05 | -21.91 | -22.20 | -23.52 | -24.75 | -24.66 | -25.87 | -25.73 | -25.98 | -24.23 | -20.75 |
Peficitinib 100 mg | -9.98 | -15.27 | -13.49 | -15.34 | -16.77 | -17.61 | -16.47 | -16.35 | -18.67 | -17.74 | -17.77 | -15.43 | -16.77 | -14.94 |
Peficitinib 150 mg | -14.99 | -21.59 | -25.26 | -28.32 | -27.34 | -27.02 | -27.21 | -27.02 | -29.50 | -29.79 | -29.07 | -28.70 | -28.59 | -26.15 |
Placebo / Peficitinib 100 mg | -0.63 | -0.95 | -2.62 | -11.76 | -12.69 | -13.18 | -16.29 | -19.54 | -19.65 | -19.45 | -21.43 | -23.40 | -21.03 | -15.37 |
Placebo / Peficitinib 150 mg | -3.87 | -2.07 | -4.43 | -16.89 | -20.62 | -20.04 | -18.02 | -19.93 | -21.99 | -21.71 | -22.31 | -25.66 | -23.24 | -18.61 |
The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -0.24 | -0.35 | -0.39 | -0.44 | -0.46 | -0.47 | -0.47 | -0.47 | -0.47 | -0.48 | -0.49 | -0.51 | -0.51 | -0.47 |
Peficitinib 100 mg | -0.10 | -0.25 | -0.30 | -0.36 | -0.34 | -0.35 | -0.35 | -0.41 | -0.40 | -0.42 | -0.39 | -0.34 | -0.36 | -0.30 |
Peficitinib 150 mg | -0.19 | -0.31 | -0.38 | -0.41 | -0.46 | -0.46 | -0.49 | -0.50 | -0.50 | -0.51 | -0.51 | -0.52 | -0.54 | -0.50 |
Placebo / Peficitinib 100 mg | -0.04 | -0.07 | -0.09 | -0.21 | -0.22 | -0.33 | -0.33 | -0.36 | -0.36 | -0.35 | -0.42 | -0.40 | -0.46 | -0.37 |
Placebo / Peficitinib 150 mg | 0.01 | 0.02 | 0.03 | -0.12 | -0.21 | -0.26 | -0.23 | -0.29 | -0.25 | -0.28 | -0.27 | -0.31 | -0.29 | -0.24 |
The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -27.48 | -33.80 | -37.99 | -39.20 | -41.10 | -41.18 | -41.51 | -41.95 | -41.27 | -42.93 | -42.65 | -43.71 | -44.11 | -41.07 |
Peficitinib 100 mg | -18.71 | -25.92 | -28.91 | -34.84 | -34.83 | -36.67 | -37.17 | -39.14 | -38.29 | -39.95 | -38.53 | -38.29 | -37.85 | -34.09 |
Peficitinib 150 mg | -19.49 | -30.55 | -35.53 | -34.68 | -38.65 | -38.50 | -39.29 | -40.49 | -40.76 | -41.88 | -42.16 | -43.41 | -44.02 | -40.56 |
Placebo / Peficitinib 100 mg | -8.77 | -11.70 | -14.85 | -26.10 | -28.43 | -30.62 | -31.69 | -30.22 | -35.44 | -36.31 | -38.01 | -39.09 | -39.43 | -33.01 |
Placebo / Peficitinib 150 mg | -12.37 | -16.04 | -18.99 | -31.35 | -33.80 | -37.43 | -37.90 | -37.27 | -38.90 | -38.83 | -37.74 | -41.99 | -43.24 | -39.28 |
"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Units on a Scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -17.09 | -20.64 | -22.54 | -23.46 | -24.44 | -24.78 | -25.70 | -25.84 | -25.77 | -26.46 | -26.17 | -26.57 | -26.77 | -24.85 |
Peficitinib 100 mg | -11.83 | -14.71 | -16.59 | -19.25 | -19.47 | -20.14 | -20.29 | -21.72 | -21.34 | -21.55 | -21.54 | -21.11 | -21.19 | -18.92 |
Peficitinib 150 mg | -12.78 | -18.66 | -21.62 | -21.90 | -23.37 | -24.40 | -25.29 | -25.28 | -25.62 | -25.78 | -25.82 | -26.33 | -26.99 | -24.95 |
Placebo / Peficitinib 100 mg | -5.57 | -7.07 | -7.48 | -15.20 | -15.67 | -16.13 | -17.75 | -17.71 | -20.57 | -20.34 | -22.65 | -23.21 | -23.04 | -18.76 |
Placebo / Peficitinib 150 mg | -7.21 | -8.43 | -10.18 | -18.90 | -20.61 | -22.25 | -22.74 | -21.14 | -22.02 | -23.09 | -23.23 | -24.61 | -25.20 | -22.38 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52
Intervention | units on a scale (Mean) | ||||
---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | |
Etanercept | 2.85 | 3.56 | 3.63 | 3.80 | 3.79 |
Peficitinib 100 mg | 1.53 | 2.91 | 2.38 | 2.95 | 4.23 |
Peficitinib 150 mg | 1.72 | 3.55 | 4.01 | 3.52 | 4.39 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52
Intervention | Units on a Scale (Mean) | ||||
---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | |
Etanercept | 6.10 | 7.35 | 8.40 | 10.28 | 11.18 |
Peficitinib 100 mg | 3.82 | 6.43 | 9.93 | 10.85 | 13.07 |
Peficitinib 150 mg | 3.20 | 6.78 | 9.63 | 10.95 | 9.88 |
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52
Intervention | Units on a Scale (Mean) | ||||
---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | |
Etanercept | 4.06 | 6.51 | 7.49 | 7.31 | 8.36 |
Peficitinib 100 mg | 0.40 | 3.80 | 1.68 | 4.18 | 3.88 |
Peficitinib 150 mg | 4.27 | 5.96 | 7.82 | 8.78 | 9.15 |
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | units on a scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -24.38 | -29.31 | -33.14 | -34.88 | -36.10 | -37.12 | -37.75 | -38.02 | -37.54 | -38.42 | -39.01 | -39.47 | -40.36 | -37.09 |
Peficitinib 100 mg | -14.66 | -21.29 | -25.09 | -29.98 | -29.82 | -30.09 | -31.19 | -34.49 | -32.11 | -34.66 | -34.87 | -35.53 | -35.61 | -28.52 |
Peficitinib 150 mg | -18.30 | -29.55 | -32.75 | -34.37 | -36.21 | -37.51 | -37.91 | -38.71 | -39.08 | -40.85 | -39.51 | -41.60 | -41.54 | -38.84 |
Placebo / Peficitinib 100 mg | -1.83 | -5.71 | -6.93 | -21.29 | -17.76 | -25.96 | -25.66 | -27.97 | -31.56 | -30.76 | -36.01 | -34.09 | -32.06 | -26.80 |
Placebo / Peficitinib 150 mg | -6.59 | -8.78 | -8.85 | -21.98 | -24.53 | -25.42 | -26.01 | -26.17 | -26.64 | -28.80 | -28.19 | -31.05 | -32.91 | -28.71 |
"The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Swollen Joints (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -6.3 | -7.6 | -8.3 | -8.7 | -9.2 | -9.1 | -9.7 | -9.8 | -9.8 | -10.0 | -9.9 | -9.9 | -10.2 | -9.7 |
Lacebo / Peficitinib 150 mg | -2.2 | -3.4 | -3.9 | -6.3 | -7.8 | -8.2 | -8.7 | -8.2 | -8.5 | -9.1 | -9.3 | -9.1 | -9.4 | -8.6 |
Peficitinib 100 mg | -4.5 | -5.6 | -6.4 | -7.7 | -7.6 | -7.9 | -8.2 | -8.2 | -8.4 | -8.4 | -8.8 | -8.6 | -8.7 | -7.7 |
Peficitinib 150 mg | -4.7 | -7.1 | -8.7 | -8.7 | -9.1 | -9.7 | -10.4 | -10.4 | -10.4 | -10.4 | -10.5 | -10.8 | -11.0 | -10.0 |
Placebo / Peficitinib 100 mg | -2.5 | -2.8 | -3.3 | -6.4 | -6.6 | -6.5 | -6.7 | -5.9 | -7.6 | -7.6 | -8.0 | -8.0 | -8.2 | -6.7 |
The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain. (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Units on a Scale (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -22.24 | -27.43 | -31.37 | -32.48 | -34.76 | -35.45 | -36.23 | -37.20 | -36.31 | -36.45 | -36.24 | -37.03 | -38.47 | -35.47 |
Peficitinib 100 mg | -14.80 | -22.45 | -25.02 | -28.58 | -29.68 | -29.78 | -31.66 | -34.15 | -32.44 | -35.06 | -34.59 | -34.87 | -33.24 | -28.49 |
Peficitinib 150 mg | -18.36 | -29.58 | -31.83 | -34.41 | -35.83 | -37.78 | -36.48 | -37.65 | -38.48 | -40.67 | -38.76 | -40.27 | -42.01 | -38.03 |
Placebo / Peficitinib 100 mg | -2.00 | -4.11 | -5.40 | -20.93 | -16.21 | -22.64 | -22.63 | -25.53 | -28.38 | -26.65 | -32.32 | -31.57 | -29.57 | -24.18 |
Placebo / Peficitinib 150 mg | -8.23 | -9.17 | -9.15 | -21.20 | -24.63 | -26.51 | -24.93 | -27.09 | -26.79 | -29.48 | -28.55 | -30.73 | -32.11 | -28.51 |
"The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Tender Joints (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | -8.3 | -10.3 | -11.0 | -11.5 | -12.0 | -12.2 | -12.6 | -12.4 | -12.6 | -12.9 | -12.8 | -12.8 | -12.8 | -11.9 |
Peficitinib 100 mg | -5.9 | -7.8 | -8.6 | -9.2 | -9.8 | -9.4 | -9.7 | -10.4 | -10.2 | -10.5 | -10.6 | -10.1 | -10.1 | -9.1 |
Peficitinib 150 mg | -5.4 | -8.6 | -10.3 | -10.3 | -11.3 | -11.3 | -12.0 | -12.2 | -11.7 | -11.8 | -12.0 | -12.4 | -12.8 | -11.5 |
Placebo / Peficitinib 100 mg | -3.9 | -4.4 | -5.0 | -7.7 | -8.1 | -7.6 | -8.4 | -9.2 | -10.1 | -9.9 | -10.7 | -11.3 | -11.4 | -9.6 |
Placebo / Peficitinib 150 mg | -4.3 | -3.9 | -5.5 | -9.6 | -10.3 | -11.7 | -11.5 | -11.1 | -11.5 | -12.2 | -12.5 | -13.2 | -12.9 | -11.9 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52
Intervention | percent impairment (Mean) | ||||
---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | |
Etanercept | -17.90 | -25.33 | -27.33 | -30.34 | -31.79 |
Peficitinib 100 mg | -10.92 | -20.10 | -21.47 | -25.18 | -28.17 |
Peficitinib 150 mg | -11.30 | -23.64 | -26.74 | -30.00 | -34.07 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52
Intervention | percent impairment (Mean) | ||||
---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | |
Etanercept | -18.33 | -20.52 | -24.11 | -29.53 | -31.36 |
Peficitinib 100 mg | -6.42 | -14.31 | -13.33 | -17.35 | -20.79 |
Peficitinib 150 mg | -6.46 | -15.42 | -19.77 | -25.85 | -23.89 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52
Intervention | Percent Impairment (Mean) | ||||
---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | |
Etanercept | -18.20 | -20.94 | -25.35 | -30.12 | -32.18 |
Peficitinib 100 mg | -5.72 | -14.16 | -13.16 | -17.48 | -21.53 |
Peficitinib 150 mg | -8.67 | -17.44 | -22.84 | -28.68 | -24.75 |
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). (NCT02308163)
Timeframe: Baseline and Week 4, 8, 12, 28, and 52
Intervention | Percent Work Time (Mean) | ||||
---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 28 | Week 52 | |
Etanercept | -3.71 | -4.33 | -4.73 | -5.03 | -4.52 |
Peficitinib 100 mg | -0.56 | -2.38 | -1.38 | -3.14 | -6.76 |
Peficitinib 150 mg | -6.35 | -6.10 | -6.69 | -6.46 | -6.35 |
Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02308163)
Timeframe: Week 0 to Week 12
Intervention | Participants (Count of Participants) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
TEAEs | Drug-related TEAEs | TEAEs leading to death | Serious TEAEs | Drug-related serious TEAEs | ≥ Grade 3 TEAEs | TEAEs leading to discontinuation | Drug-related TEAEs leading to discontinuation | Serious TEAEs leading to discontinuation | Drug-related serious TEAEs leading to discont. | |
Etanercept | 119 | 75 | 0 | 4 | 4 | 6 | 5 | 5 | 2 | 2 |
Peficitinib 100 mg | 49 | 33 | 0 | 3 | 2 | 6 | 6 | 4 | 2 | 1 |
Peficitinib 150 mg | 55 | 38 | 0 | 2 | 1 | 3 | 3 | 2 | 2 | 1 |
Placebo | 54 | 29 | 0 | 4 | 3 | 8 | 4 | 1 | 2 | 1 |
Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. (NCT02308163)
Timeframe: Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study
Intervention | Participants (Count of Participants) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
TEAEs | Drug-related TEAEs | TEAEs leading to death | Serious TEAEs | Drug-related serious TEAEs | ≥ Grade 3 TEAEs | TEAEs leading to discontinuation | Drug-related TEAEs leading to discontinuation | Serious TEAEs leading to discontinuation | Drug-related serious TEAEs leading to discont. | |
Etanercept | 156 | 93 | 0 | 14 | 5 | 23 | 8 | 6 | 3 | 2 |
Peficitinib 100 mg | 78 | 50 | 0 | 5 | 2 | 9 | 7 | 3 | 4 | 2 |
Peficitinib 150 mg | 79 | 47 | 0 | 6 | 2 | 16 | 3 | 2 | 0 | 0 |
Placebo / Peficitinib 100 mg | 41 | 27 | 0 | 4 | 2 | 2 | 2 | 2 | 1 | 1 |
Placebo / Peficitinib 150 mg | 37 | 26 | 0 | 5 | 2 | 12 | 4 | 4 | 2 | 2 |
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm). (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 7.0 | 11.8 | 14.1 | 18.6 | 20.9 | 28.0 | 24.3 | 25.0 | 22.3 | 24.3 | 25.1 | 27.4 | 30.2 | 25.0 |
Peficitinib 100 mg | 1.0 | 2.1 | 6.3 | 11.8 | 12.0 | 13.8 | 12.0 | 13.6 | 16.5 | 16.0 | 16.0 | 17.6 | 18.3 | 14.7 |
Peficitinib 150 mg | 0.0 | 1.0 | 6.5 | 8.6 | 13.0 | 10.1 | 18.0 | 20.9 | 18.6 | 19.8 | 24.7 | 25.0 | 18.5 | 15.8 |
Placebo / Peficitinib 100 mg | 0.0 | 2.3 | 0.0 | 4.8 | 4.8 | 5.0 | 9.8 | 10.8 | 8.1 | 7.9 | 20.0 | 25.7 | 22.9 | 20.9 |
Placebo / Peficitinib 150 mg | 0.0 | 0.0 | 4.3 | 2.1 | 6.5 | 8.9 | 10.9 | 11.1 | 7.0 | 14.3 | 7.7 | 15.4 | 10.5 | 8.5 |
"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 9.0 | 14.4 | 19.9 | 23.9 | 28.0 | 31.9 | 31.6 | 32.4 | 30.3 | 31.8 | 33.3 | 36.3 | 38.3 | 32.5 |
Peficitinib 100 mg | 1.0 | 4.2 | 9.4 | 14.0 | 18.5 | 16.1 | 20.5 | 17.3 | 19.0 | 22.4 | 21.3 | 23.0 | 21.1 | 18.4 |
Peficitinib 150 mg | 2.0 | 6.1 | 10.9 | 16.1 | 17.4 | 15.6 | 27.0 | 27.9 | 26.7 | 29.1 | 36.5 | 34.5 | 27.2 | 23.8 |
Placebo / Peficitinib 100 mg | 0.0 | 0.0 | 0.0 | 2.4 | 2.4 | 7.5 | 14.6 | 16.2 | 18.9 | 13.2 | 25.7 | 28.6 | 22.9 | 20.9 |
Placebo / Peficitinib 150 mg | 0.0 | 0.0 | 0.0 | 6.4 | 10.9 | 15.6 | 17.4 | 13.3 | 7.0 | 21.4 | 15.4 | 23.1 | 18.4 | 17.0 |
"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 26.0 | 37.4 | 47.6 | 53.2 | 59.3 | 59.9 | 61.6 | 68.2 | 61.7 | 68.8 | 69.6 | 70.8 | 67.9 | 61.5 |
Peficitinib 100 mg | 10.2 | 19.8 | 25.0 | 35.5 | 37.0 | 37.9 | 36.1 | 38.3 | 49.4 | 45.3 | 46.7 | 43.2 | 43.7 | 39.2 |
Peficitinib 150 mg | 5.0 | 23.5 | 37.0 | 39.8 | 51.1 | 51.7 | 55.1 | 55.8 | 54.7 | 53.5 | 57.6 | 61.9 | 66.7 | 59.4 |
Placebo / Peficitinib 100 mg | 0.0 | 9.3 | 7.1 | 21.4 | 16.7 | 25.0 | 34.1 | 37.8 | 43.2 | 36.8 | 48.6 | 51.4 | 45.7 | 41.9 |
Placebo / Peficitinib 150 mg | 2.1 | 2.1 | 4.3 | 23.4 | 32.6 | 33.3 | 41.3 | 37.8 | 39.5 | 45.2 | 41.0 | 56.4 | 55.3 | 51.1 |
"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 47.0 | 59.5 | 70.2 | 73.4 | 75.8 | 77.5 | 81.9 | 83.0 | 83.4 | 85.0 | 83.0 | 86.3 | 89.5 | 81.5 |
Peficitinib 100 mg | 18.4 | 32.3 | 41.7 | 52.7 | 55.4 | 50.6 | 55.4 | 58.0 | 63.3 | 62.7 | 61.3 | 64.9 | 63.4 | 54.9 |
Peficitinib 150 mg | 21.0 | 40.8 | 55.4 | 64.5 | 67.4 | 74.2 | 76.4 | 70.9 | 75.6 | 76.7 | 75.3 | 81.0 | 84.0 | 77.2 |
Placebo / Peficitinib 100 mg | 4.7 | 11.6 | 14.3 | 33.3 | 45.2 | 35.0 | 41.5 | 51.4 | 56.8 | 57.9 | 57.1 | 60.0 | 54.3 | 48.8 |
Placebo / Peficitinib 150 mg | 4.3 | 12.8 | 10.6 | 44.7 | 47.8 | 62.2 | 63.0 | 55.6 | 67.4 | 71.4 | 74.4 | 79.5 | 81.6 | 76.6 |
"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 14.5 | 27.7 | 33.2 | 35.1 | 38.1 | 41.4 | 39.8 | 43.4 | 40.0 | 43.9 | 43.3 | 47.6 | 43.2 | 39.5 |
Peficitinib 100 mg | 2.0 | 8.4 | 11.5 | 18.3 | 22.0 | 23.0 | 27.7 | 22.2 | 25.3 | 28.9 | 32.0 | 24.3 | 25.4 | 23.3 |
Peficitinib 150 mg | 4.0 | 13.3 | 19.6 | 26.1 | 28.6 | 34.1 | 34.8 | 30.2 | 41.2 | 44.2 | 48.2 | 39.3 | 34.6 | 28.7 |
Placebo / Peficitinib 100 mg | 0.0 | 0.0 | 2.4 | 11.9 | 14.6 | 15.4 | 26.8 | 19.4 | 25.0 | 32.4 | 35.3 | 37.1 | 29.4 | 26.2 |
Placebo / Peficitinib 150 mg | 2.1 | 0.0 | 0.0 | 14.9 | 19.6 | 17.8 | 21.7 | 24.4 | 18.6 | 28.6 | 28.2 | 38.5 | 28.9 | 27.7 |
"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 33.0 | 42.6 | 51.1 | 53.7 | 56.9 | 58.6 | 60.8 | 65.7 | 62.3 | 67.1 | 64.3 | 72.6 | 62.3 | 58.0 |
Peficitinib 100 mg | 9.2 | 20.0 | 19.8 | 32.3 | 36.3 | 37.9 | 36.1 | 42.0 | 48.1 | 51.3 | 48.0 | 45.9 | 45.1 | 38.8 |
Peficitinib 150 mg | 10.0 | 24.5 | 39.1 | 42.4 | 51.6 | 50.0 | 59.6 | 54.7 | 61.2 | 59.3 | 60.0 | 61.9 | 69.1 | 61.4 |
Placebo / Peficitinib 100 mg | 0.0 | 9.3 | 7.1 | 21.4 | 19.5 | 23.1 | 36.6 | 38.9 | 41.7 | 43.2 | 50.0 | 54.3 | 41.2 | 38.1 |
Placebo / Peficitinib 150 mg | 4.3 | 2.2 | 8.5 | 25.5 | 34.8 | 37.8 | 41.3 | 40.0 | 37.2 | 47.6 | 46.2 | 53.8 | 52.6 | 46.8 |
"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3." (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 10.0 | 16.9 | 19.4 | 23.9 | 29.7 | 34.1 | 33.9 | 35.2 | 30.9 | 33.5 | 34.5 | 39.3 | 39.5 | 33.5 |
Peficitinib 100 mg | 1.0 | 4.2 | 9.4 | 12.9 | 17.4 | 18.4 | 19.3 | 16.0 | 21.5 | 24.0 | 22.7 | 18.9 | 21.1 | 17.6 |
Peficitinib 150 mg | 1.0 | 6.1 | 9.8 | 15.1 | 18.5 | 18.0 | 29.2 | 27.9 | 27.9 | 36.0 | 38.8 | 38.1 | 29.6 | 25.7 |
Placebo / Peficitinib 100 mg | 0.0 | 0.0 | 0.0 | 2.4 | 4.8 | 10.0 | 17.1 | 13.5 | 18.9 | 10.5 | 20.0 | 28.6 | 20.0 | 18.6 |
Placebo / Peficitinib 150 mg | 0.0 | 0.0 | 0.0 | 8.5 | 15.2 | 17.8 | 17.4 | 13.3 | 4.7 | 19.0 | 15.4 | 25.6 | 21.1 | 17.0 |
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 44.5 | 56.4 | 67.5 | 72.9 | 75.8 | 76.4 | 80.8 | 83.0 | 83.4 | 84.4 | 82.5 | 85.1 | 88.3 | 80.0 |
Peficitinib 100 mg | 17.3 | 28.1 | 39.6 | 48.4 | 51.1 | 47.1 | 50.6 | 54.3 | 59.5 | 58.7 | 58.7 | 60.8 | 59.2 | 52.5 |
Peficitinib 150 mg | 16.0 | 39.8 | 53.3 | 60.2 | 65.2 | 71.9 | 74.2 | 68.6 | 74.4 | 75.6 | 74.1 | 79.8 | 81.5 | 75.2 |
Placebo / Peficitinib 100 mg | 4.8 | 11.9 | 12.2 | 34.1 | 46.3 | 33.3 | 40.0 | 50.0 | 55.6 | 54.1 | 55.9 | 55.9 | 52.9 | 47.6 |
Placebo / Peficitinib 150 mg | 2.1 | 6.4 | 8.5 | 40.4 | 43.5 | 57.8 | 58.7 | 46.7 | 62.8 | 66.7 | 71.8 | 79.5 | 78.9 | 72.3 |
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 31.7 | 41.2 | 50.0 | 52.7 | 56.4 | 56.4 | 59.7 | 63.4 | 62.3 | 67.1 | 63.7 | 72.6 | 61.7 | 57.3 |
Peficitinib 100 mg | 8.2 | 16.8 | 18.8 | 31.2 | 34.1 | 35.6 | 32.5 | 39.5 | 44.3 | 47.4 | 45.3 | 41.9 | 43.7 | 38.2 |
Peficitinib 150 mg | 10.0 | 24.5 | 38.0 | 40.2 | 51.6 | 50.0 | 59.6 | 54.7 | 60.0 | 59.3 | 60.0 | 61.9 | 69.1 | 61.4 |
Placebo / Peficitinib 100 mg | 0.0 | 9.5 | 4.9 | 22.0 | 20.0 | 21.1 | 35.0 | 37.1 | 40.0 | 41.7 | 48.5 | 52.9 | 39.4 | 36.6 |
Placebo / Peficitinib 150 mg | 2.2 | 0.0 | 6.5 | 21.7 | 31.1 | 34.1 | 37.8 | 36.4 | 33.3 | 43.9 | 43.6 | 52.6 | 48.6 | 43.5 |
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 87.5 | 92.3 | 94.2 | 96.8 | 95.6 | 97.3 | 99.4 | 98.3 | 97.7 | 100.0 | 99.4 | 98.2 | 98.8 | 95.5 |
Peficitinib 100 mg | 63.3 | 76.0 | 77.1 | 81.7 | 79.3 | 85.1 | 89.2 | 91.4 | 87.3 | 89.3 | 93.3 | 90.5 | 91.5 | 78.2 |
Peficitinib 150 mg | 72.0 | 86.7 | 94.6 | 92.5 | 96.7 | 96.6 | 95.5 | 96.5 | 96.5 | 96.5 | 94.1 | 97.6 | 98.8 | 93.1 |
Placebo / Peficitinib 100 mg | 31.0 | 47.6 | 41.5 | 73.2 | 78.0 | 71.8 | 80.0 | 83.3 | 86.1 | 86.5 | 88.2 | 94.1 | 94.1 | 83.3 |
Placebo / Peficitinib 150 mg | 40.4 | 40.4 | 48.9 | 85.1 | 91.3 | 91.1 | 87.0 | 82.2 | 86.0 | 85.7 | 87.2 | 89.7 | 92.1 | 85.1 |
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. (NCT02308163)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 81.9 | 92.8 | 92.6 | 94.7 | 93.9 | 96.1 | 97.7 | 97.1 | 96.6 | 98.3 | 98.2 | 98.2 | 98.1 | 93.5 |
Peficitinib 100 mg | 56.1 | 66.3 | 70.8 | 76.3 | 79.1 | 82.8 | 84.3 | 90.1 | 83.5 | 89.5 | 90.7 | 86.5 | 84.5 | 74.5 |
Peficitinib 150 mg | 65.0 | 84.7 | 90.2 | 88.0 | 96.7 | 95.5 | 92.1 | 94.2 | 95.3 | 95.3 | 92.9 | 95.2 | 97.5 | 94.1 |
Placebo / Peficitinib 100 mg | 31.0 | 45.2 | 39.0 | 73.2 | 72.5 | 73.7 | 77.5 | 77.1 | 85.7 | 83.3 | 84.8 | 88.2 | 84.8 | 75.6 |
Placebo / Peficitinib 150 mg | 23.9 | 33.3 | 43.5 | 76.1 | 86.7 | 90.9 | 88.9 | 86.4 | 83.3 | 85.4 | 87.2 | 89.5 | 89.2 | 82.6 |
"The ACR20 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 20% reduction compared with baseline.~SJC : ≥ 20% reduction compared with baseline.~≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of Treatment (EOT) | |
Etanercept | 61.0 | 80.5 | 84.8 | 86.7 | 88.5 | 90.1 | 92.7 | 88.1 | 92.0 | 92.5 | 91.2 | 90.5 | 90.7 | 86.5 |
Peficitinib 100 mg | 43.9 | 51.0 | 59.4 | 64.5 | 64.1 | 63.2 | 72.3 | 76.5 | 72.2 | 73.7 | 74.7 | 74.3 | 73.2 | 65.4 |
Peficitinib 150 mg | 45.0 | 68.7 | 77.2 | 79.6 | 81.5 | 85.6 | 87.6 | 88.4 | 90.7 | 90.7 | 88.2 | 90.5 | 90.1 | 84.3 |
Placebo / Peficitinib 100 mg | 21.4 | 38.1 | 31.7 | 58.5 | 51.2 | 61.5 | 60.0 | 63.9 | 66.7 | 67.6 | 79.4 | 73.5 | 79.4 | 67.4 |
Placebo / Peficitinib 150 mg | 19.1 | 25.5 | 34.0 | 61.7 | 71.7 | 71.1 | 67.4 | 73.3 | 76.7 | 83.3 | 84.6 | 82.1 | 81.6 | 74.5 |
"The ACR50 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 50% reduction compared with baseline.~SJC : ≥ 50% reduction compared with baseline.~≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 29.5 | 47.2 | 55.0 | 60.6 | 66.5 | 64.8 | 69.5 | 70.5 | 70.3 | 73.4 | 70.2 | 75.6 | 77.2 | 69.0 |
Peficitinib 100 mg | 8.2 | 25.0 | 32.3 | 43.0 | 41.3 | 43.7 | 44.6 | 50.6 | 53.2 | 47.4 | 50.7 | 48.6 | 49.3 | 43.3 |
Peficitinib 150 mg | 14.0 | 35.4 | 45.7 | 45.2 | 54.3 | 62.2 | 60.7 | 65.1 | 68.6 | 69.8 | 69.4 | 73.8 | 75.3 | 66.7 |
Placebo / Peficitinib 100 mg | 4.8 | 4.8 | 7.3 | 31.7 | 22.0 | 38.5 | 40.0 | 52.8 | 47.2 | 45.9 | 50.0 | 58.8 | 47.1 | 41.9 |
Placebo / Peficitinib 150 mg | 2.1 | 6.4 | 12.8 | 25.5 | 43.5 | 44.4 | 50.0 | 44.4 | 44.2 | 52.4 | 53.8 | 69.2 | 65.8 | 55.3 |
"The ACR70 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 70% reduction compared with baseline.~SJC : ≥ 70% reduction compared with baseline.~≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP." (NCT02308163)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Intervention | Percentage of Participants (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | EOT | |
Etanercept | 14.5 | 20.5 | 31.9 | 37.8 | 41.8 | 44.5 | 48.0 | 47.7 | 44.6 | 49.7 | 52.0 | 54.2 | 56.2 | 48.0 |
Peficitinib 100 mg | 1.0 | 11.5 | 14.6 | 23.7 | 26.1 | 28.7 | 25.3 | 28.4 | 31.6 | 28.9 | 30.7 | 33.8 | 35.2 | 31.7 |
Peficitinib 150 mg | 2.0 | 14.1 | 29.3 | 28.0 | 30.4 | 40.0 | 38.2 | 39.5 | 43.0 | 47.7 | 49.4 | 51.2 | 48.1 | 42.2 |
Placebo / Peficitinib 100 mg | 0.0 | 0.0 | 0.0 | 7.3 | 7.3 | 15.4 | 20.0 | 25.0 | 27.8 | 27.0 | 41.2 | 32.4 | 38.2 | 34.9 |
Placebo / Peficitinib 150 mg | 0.0 | 2.1 | 2.1 | 8.5 | 19.6 | 22.2 | 17.4 | 24.4 | 18.6 | 35.7 | 28.2 | 38.5 | 42.1 | 34.0 |
3 reviews available for niacinamide and Shingles
Article | Year |
---|---|
A pooled analysis of serious infections and herpes zoster-related disease in Asian patients with rheumatoid arthritis treated with peficitinib (ASP015K) over a median of 3 years.
Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Herpes Zoster; Humans; Niacinamide; Prednis | 2022 |
JAK inhibitors for the treatment of rheumatoid arthritis.
Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Azetidines; Benzofurans; Cardiovascular Dis | 2020 |
Efficacy and safety of peficitinib in rheumatoid arthritis.
Topics: Adamantane; Antirheumatic Agents; Arthritis, Rheumatoid; Clinical Trials, Phase II as Topic; Herpes | 2020 |
4 trials available for niacinamide and Shingles
4 other studies available for niacinamide and Shingles
Article | Year |
---|---|
Measuring herpes zoster, zoster-associated pain, post-herpetic neuralgia-associated loss of quality of life, and healthcare utilization and costs in Thailand.
Topics: Adult; Aged; Ambulatory Care; Cohort Studies; Female; Health Expenditures; Herpes Zoster; Humans; Im | 2011 |
[1ST TRIALS WITH MEDIVITAN IN HERPES ZOSTER].
Topics: Corrinoids; Folic Acid; Herpes Zoster; Humans; Niacin; Niacinamide; Pyridoxine; Vitamin B 12; Vitami | 1963 |
[EXPERIENCES WITH THE PREPARATION "MEDIVITAN" IN HERPES ZOSTER IN GENERAL PRACTICE].
Topics: Corrinoids; Folic Acid; General Practice; Hematinics; Herpes Zoster; Humans; Niacin; Niacinamide; Vi | 1964 |
Novel histamine H3 receptor antagonists GSK189254 and GSK334429 are efficacious in surgically-induced and virally-induced rat models of neuropathic pain.
Topics: Animals; Azepines; Benzazepines; Disease Models, Animal; Herpes Zoster; Histamine H3 Antagonists; Hu | 2008 |