Page last updated: 2024-10-26

diclofenac and Coxarthrosis

diclofenac has been researched along with Coxarthrosis in 39 studies

Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.

Research Excerpts

ExcerptRelevanceReference
"To evaluate the efficacy and safety of intra-articular injection of diclofenac etalhyaluronate (DF-HA) in patients with osteoarthritis (OA) of the hip, ankle, shoulder, or elbow."9.51Diclofenac-hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial. ( Ikegami, H; Kano, K; Kubo, T; Kumai, T; Nishii, M; Seo, T, 2022)
"A six week, double-blind, randomized, parallel group, multicentre study was conducted in 85 patients with osteoarthritis of the knee and hip to compare the efficacy, tolerability, and safety of Flurbiprofen-SR 200 mg with Diclofenac Sodium-SR 100 mg."9.07Double-blind randomized controlled trial of flurbiprofen-SR (ANSAID-SR) and diclofenac sodium-SR (Voltaren-SR) in the treatment of osteoarthritis. ( Bellamy, N; Bensen, WG; Ford, PM; Huang, SH; Lang, JY, 1992)
"To evaluate the efficacy and safety of intra-articular injection of diclofenac etalhyaluronate (DF-HA) in patients with osteoarthritis (OA) of the hip, ankle, shoulder, or elbow."5.51Diclofenac-hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial. ( Ikegami, H; Kano, K; Kubo, T; Kumai, T; Nishii, M; Seo, T, 2022)
"Nephrotic syndrome, with or without concomitant tubulointerstitial nephritis, is a rare renal adverse effect of NSAIDs."5.37Safe administration of celecoxib to a patient with repeated episodes of nephrotic syndrome induced by NSAIDs. ( Knotek, M; Ljubanovic, D; Mihovilovic, K, 2011)
"A six week, double-blind, randomized, parallel group, multicentre study was conducted in 85 patients with osteoarthritis of the knee and hip to compare the efficacy, tolerability, and safety of Flurbiprofen-SR 200 mg with Diclofenac Sodium-SR 100 mg."5.07Double-blind randomized controlled trial of flurbiprofen-SR (ANSAID-SR) and diclofenac sodium-SR (Voltaren-SR) in the treatment of osteoarthritis. ( Bellamy, N; Bensen, WG; Ford, PM; Huang, SH; Lang, JY, 1992)
"This study investigated the efficacy and safety of a diclofenac/orphenadrin infusion in 21 female and 1 male patients with clinically and radiologically diagnosed inflammatory osteoarthritis of the big joints, especially the knee and hip joints."3.70[Diclofenac/orphenadrine infusion therapy in patients with active arthrosis]. ( Aglas, F; Rainer, F; Uitz, E; Wurm, A, 1998)
"The tissue concentration of diclofenac sodium, the active substance of Voltaren SR 75 mg tablets, was studied in 10 patients with coxarthrosis."3.70Tissue concentration of the active substance of Voltaren SR 75 in articular cartilage, synovial membrane and bone. ( Bariska, J; Bender, T; Schäfer, M, 2000)
" Adverse events (AEs) were similar between patients treated with tanezumab 2."3.01Long-Term Safety and Efficacy of Subcutaneous Tanezumab Versus Nonsteroidal Antiinflammatory Drugs for Hip or Knee Osteoarthritis: A Randomized Trial. ( Brown, MT; Carrino, JA; Fountaine, RJ; Guermazi, A; Hickman, A; Hochberg, MC; Nakajo, S; Pixton, G; Schnitzer, TJ; Verburg, KM; Viktrup, L; Walsh, DA; West, CR; White, A, 2021)
"Diclofenac is used for the treatment of osteoarthritis (OA); however, like other nonsteroidal anti-inflammatory drugs (NSAIDs) it can be associated with serious dose-related adverse events (AEs)."2.80Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study. ( Altman, RD; Cryer, B; Gibofsky, A; Hochberg, MC; Hopkins, WE; Imasogie, O; Kivitz, A; Markenson, JA; Nezzer, J; Strand, V; Young, CL, 2015)
" The incidence of adverse events of abnormal peripheral sensation was lower than in previous tanezumab trials."2.79Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial. ( Balanescu, AR; Brown, MT; Davignon, I; Feist, E; Smith, MD; West, CR; Wolfram, G, 2014)
"NSAIDs, such as diclofenac, are the most commonly used medications to treat osteoarthritis (OA), but they are associated with dose-related adverse events (AEs)."2.79Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study. ( Gibofsky, A; Hochberg, MC; Jaros, MJ; Young, CL, 2014)
"Electroacupuncture can treat effectively hip osteoarthritis, relieve joint pain and improve joint function."2.75[Comparative observation on hip osteoarthritis treated with electroacupuncture and medication]. ( Fan, TY; Sheng, XP, 2010)
"Celecoxib was declared noninferior to diclofenac if the upper limit of the 2-sided 95% CI of the treatment difference (celecoxib vs diclofenac) in the mean change from baseline in VAS did not exceed 10 mm."2.73Analgesic effectiveness of celecoxib and diclofenac in patients with osteoarthritis of the hip requiring joint replacement surgery: a 12-week, multicenter, randomized, double-blind, parallel-group, double-dummy, noninferiority study. ( Emery, P; Koncz, T; Lowry, S; Pan, S, 2008)
" Efficacy assessments included overall joint pain intensity and Western Ontario and McMaster Universities Osteoarthritis Index subscales; tolerability was evaluated by adverse event and physician reporting."2.71Efficacy and safety of four doses of lumiracoxib versus diclofenac in patients with knee or hip primary osteoarthritis: a phase II, four-week, multicenter, randomized, double-blind, placebo-controlled trial. ( Beier, J; Geusens, P; Gitton, X; Hasler, P; Moore, A; Patel, SK; Poór, G; Schnitzer, TJ; Senftleber, I; Sloan, VS, 2004)
"Acetaminophen was associated with fewer adverse events."2.70A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee. ( Abramson, SB; Caldwell, JR; Callahan, LF; Cummins, P; Fort, J; Harrell, RA; Jordan, JM; Koch, GG; Kremer, JM; Lautzenheiser, RL; Lefkowith, J; Luta, G; Markenson, JA; Morant, S; Pincus, T; Schnitzer, TJ; Schwartz, T; Sokka, T; Wang, X; Weaver, A; Wilson, A; Wolfe, F, 2001)
"80 outpatients with active primary osteoarthrosis with a radiological grade of II or III in the hip or knee joint (mean duration 4 years) were distributed randomly and equally to each treatment group."2.69[Oxaprozin versus diclofenac retard in treated of activated arthrosis]. ( Eckardt, A; Karbowski, A; Schwitalle, M, 1998)
" However, compliance is limited by the different dosing regimens of misoprostol and NSAID and GI symptoms associated with misoprostol at its recommended q."2.69Diclofenac/misoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip: a randomized, placebo controlled trial. Arthrotec Osteoarthritis Study Group. ( Ball, JA; Bocanegra, TS; Fort, JG; Geis, GS; Sikes, DH; Tindall, EA; Wallemark, CB; Weaver, AL, 1998)
"diclofenac (n = 131) were assessed in a multicentre, randomised, double-blind study of a mixed population of patients with osteoarthritis of the knee and/or hip."2.69Oxaceprol is a well-tolerated therapy for osteoarthritis with efficacy equivalent to diclofenac. ( Dirschedl, H; Fürst, M; Gimbel, W; Herrmann, G; Hildebrandt, HD; Jungmichel, D; Klasser, M; Parnham, MJ; Rohde, H; Steeger, D; Venbrocks, R; Wirbitzky, J, 2000)
"Rofecoxib was well tolerated and provided efficacy that was clinically comparable, according to predefined statistical criteria, to that of 150 mg of diclofenac per day in this 1-year study."2.69Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip. Rofecoxib Phase III Protocol 035 ( Bolognese, J; Caldwell, JR; Cannon, GW; Daniels, B; Ehrich, E; Holt, P; McLean, B; Mukhopadhyay, S; Seidenberg, B, 2000)
"Celecoxib is a selective non-steroidal anti-inflammatory drug (NSAID)."2.55Celecoxib for osteoarthritis. ( Marin, A; Markotic, F; Puljak, L; Tugwell, P; Utrobicic, A; Vrdoljak, D, 2017)
"Nephrotic syndrome, with or without concomitant tubulointerstitial nephritis, is a rare renal adverse effect of NSAIDs."1.37Safe administration of celecoxib to a patient with repeated episodes of nephrotic syndrome induced by NSAIDs. ( Knotek, M; Ljubanovic, D; Mihovilovic, K, 2011)

Research

Studies (39)

TimeframeStudies, this research(%)All Research%
pre-19901 (2.56)18.7374
1990's10 (25.64)18.2507
2000's15 (38.46)29.6817
2010's11 (28.21)24.3611
2020's2 (5.13)2.80

Authors

AuthorsStudies
Kubo, T1
Kumai, T1
Ikegami, H1
Kano, K1
Nishii, M1
Seo, T1
Hochberg, MC3
Carrino, JA1
Schnitzer, TJ4
Guermazi, A1
Walsh, DA1
White, A1
Nakajo, S1
Fountaine, RJ1
Hickman, A1
Pixton, G1
Viktrup, L1
Brown, MT2
West, CR2
Verburg, KM1
Sivordova, LE1
Zavodovsky, BV1
Polyakova, JV1
Akhverdyan, YR1
Puljak, L1
Marin, A1
Vrdoljak, D1
Markotic, F1
Utrobicic, A1
Tugwell, P1
Balanescu, AR1
Feist, E1
Wolfram, G1
Davignon, I1
Smith, MD1
Gibofsky, A3
Jaros, MJ1
Young, CL2
Altman, RD1
Strand, V2
Markenson, JA2
Hopkins, WE1
Cryer, B1
Kivitz, A2
Nezzer, J1
Imasogie, O1
Bergman, M1
Singh, JA1
Young, C1
Maĭko, OIu1
Bagirova, GG1
Mihovilovic, K1
Ljubanovic, D1
Knotek, M1
Sheng, XP1
Fan, TY1
Dattani, ID1
Seriolo, B1
Schneider, H1
Moore, A2
Tseng, L1
Sallstig, P1
Rebuli, R1
Maxwell, T1
Drozdov, VN1
Kim, VA1
Tkachenko, EV1
Varvanina, GG1
Zacher, J1
Feldman, D1
Gerli, R1
Scott, D1
Hou, SM1
Uebelhart, D1
Rodger, IW1
Ozturk, ZE1
Saito, N1
Horiuchi, H1
Kobayashi, S1
Nawata, M1
Takaoka, K1
Beier, J1
Geusens, P1
Hasler, P1
Patel, SK1
Senftleber, I1
Gitton, X1
Sloan, VS1
Poór, G1
Pincus, T2
Wang, X2
Chung, C1
Sokka, T2
Koch, GG2
Reijman, M1
Bierma-Zeinstra, SM1
Pols, HA1
Koes, BW1
Stricker, BH1
Hazes, JM1
Ding, C1
Emery, P1
Koncz, T1
Pan, S1
Lowry, S1
Chayen, J1
Bitensky, L1
Mehdizadeh, S1
Dunham, J1
Older, J1
Karbowski, A1
Schwitalle, M1
Eckardt, A1
Uitz, E1
Aglas, F1
Wurm, A1
Rainer, F1
Bocanegra, TS1
Weaver, AL1
Tindall, EA1
Sikes, DH1
Ball, JA1
Wallemark, CB1
Geis, GS1
Fort, JG1
Bauer, HW1
Klasser, M2
von Hanstein, KL1
Rolinger, H1
Schladitz, G1
Henke, HD1
Gimbel, W2
Steinbach, K1
Becvár, R1
Urbanová, Z1
Vlasáková, V1
Vítová, J1
Rybár, I1
Maldyk, H1
Filipowicz-Sosnowska, A1
Bernacka, K1
Mackiewicz, S1
Gömör, B1
Rojkovich, B1
Siro, B1
Bereczki, J1
Toth, K1
Sukenik, S1
Green, L1
Ehrenfeld, M1
Pavelka, K1
Zgradie, I1
Bender, T1
Schäfer, M1
Bariska, J1
Herrmann, G1
Steeger, D1
Wirbitzky, J1
Fürst, M1
Venbrocks, R1
Rohde, H1
Jungmichel, D1
Hildebrandt, HD1
Parnham, MJ1
Dirschedl, H1
Cannon, GW1
Caldwell, JR2
Holt, P1
McLean, B1
Seidenberg, B1
Bolognese, J1
Ehrich, E1
Mukhopadhyay, S1
Daniels, B1
Kakar, S1
Jeffery, JA1
Bentley, G1
Lefkowith, J1
Wolfe, F1
Jordan, JM1
Luta, G1
Callahan, LF1
Schwartz, T1
Abramson, SB1
Harrell, RA1
Kremer, JM1
Lautzenheiser, RL1
Weaver, A1
Cummins, P1
Wilson, A1
Morant, S1
Fort, J1
Blandino, D1
Ravaud, P1
Corts Giner, JR1
García Borrás, JJ1
Bellamy, N1
Bensen, WG1
Ford, PM1
Huang, SH1
Lang, JY1
Vignon, E1
Mathieu, P1
Louisot, P1
Richard, M1

Clinical Trials (7)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE[NCT02528188]Phase 33,021 participants (Actual)Interventional2015-07-21Completed
EN20-01: A 24 Week Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Moderate to Severe Knee Osteoarthritis Pain.[NCT05025787]Phase 277 participants (Anticipated)Interventional2021-10-25Recruiting
A PHASE 3, RANDOMIZED, DOUBLE BLIND, CONTROLLED, MULTI CENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ADDED ON TO DICLOFENAC SR IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP[NCT00864097]Phase 3607 participants (Actual)Interventional2009-08-11Terminated (stopped due to See termination reason in detailed description.)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip[NCT01461369]Phase 3305 participants (Actual)Interventional2011-10-31Completed
A Multicenter, Open-Label, Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip[NCT01510912]Phase 3602 participants (Actual)Interventional2012-01-31Completed
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control[NCT00154219]Phase 31,200 participants Interventional2004-11-30Completed
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip[NCT00542087]Phase 3516 participants (Actual)Interventional2002-03-22Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16

"PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition." (NCT02528188)
Timeframe: Baseline, Week 16

Interventionunits on a scale (Least Squares Mean)
Tanezumab 2.5 mg-0.96
Tanezumab 5 mg-0.97
NSAID-0.94

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. (NCT02528188)
Timeframe: Baseline, Week 16

Interventionunits on a scale (Least Squares Mean)
Tanezumab 2.5 mg-3.22
Tanezumab 5 mg-3.33
NSAID-3.07

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. (NCT02528188)
Timeframe: Baseline, Week 16

Interventionunits on a scale (Least Squares Mean)
Tanezumab 2.5 mg-3.27
Tanezumab 5 mg-3.39
NSAID-3.08

Number of Days of Rescue Medication Used During Week 64

In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized. (NCT02528188)
Timeframe: Week 64

Interventiondays (Mean)
Tanezumab 2.5 mg2.0
Tanezumab 5 mg2.3
NSAID1.7

Number of Participants Who Took Rescue Medication During Week 64

In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during Week 64 were summarized. (NCT02528188)
Timeframe: Week 64

InterventionParticipants (Count of Participants)
Tanezumab 2.5 mg251
Tanezumab 5 mg268
NSAID215

Number of Participants Who Withdrew Due to Lack of Efficacy

Number of participants who withdrew from treatment due to lack of efficacy have been reported here. (NCT02528188)
Timeframe: Baseline up to Week 56

InterventionParticipants (Count of Participants)
Tanezumab 2.5 mg60
Tanezumab 5 mg63
NSAID91

Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline

Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; specific gravity<1.003, >1.030; Urine erythrocytes,Leukocytes>=20; Hyaline Casts>=1. (NCT02528188)
Timeframe: Baseline up to Week 80

InterventionParticipants (Count of Participants)
Tanezumab 2.5 mg78
Tanezumab 5 mg61
NSAID84

Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline

Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; Leukocytes <0.6*LLN, >1.5*ULN; Lymphocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8;Urine erythrocytes,Leukocytes>=20. (NCT02528188)
Timeframe: Baseline up to Week 80

InterventionParticipants (Count of Participants)
Tanezumab 2.5 mg109
Tanezumab 5 mg102
NSAID121

Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk. (NCT02528188)
Timeframe: Baseline up to Week 80

Interventionevents per 1000 participant-years (Number)
Tanezumab 2.5 mg38.3
Tanezumab 5 mg71.5
NSAID14.8

Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk. (NCT02528188)
Timeframe: Baseline up to Week 80

Interventionevents per 1000 participant-years (Number)
Tanezumab 2.5 mg9.7
Tanezumab 5 mg21.8
NSAID4.9

Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk. (NCT02528188)
Timeframe: Baseline up to Week 80

Interventionevents per 1000 participant-years (Number)
Tanezumab 2.5 mg84.9
Tanezumab 5 mg132.5
NSAID36.7

Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome

Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to [>=] 2 millimeters [mm]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA. (NCT02528188)
Timeframe: Baseline up to Week 80

Interventionpercentage of participants (Number)
Tanezumab 2.5 mg3.9
Tanezumab 5 mg7.1
NSAID1.5

Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome

Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA. (NCT02528188)
Timeframe: Baseline up to Week 80

Interventionpercentage of participants (Number)
Tanezumab 2.5 mg1.0
Tanezumab 5 mg2.2
NSAID0.5

Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome

Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. (NCT02528188)
Timeframe: Baseline up to Week 80

Interventionpercentage of participants (Number)
Tanezumab 2.5 mg8.6
Tanezumab 5 mg13.1
NSAID3.7

Time to Discontinuation Due to Lack of Efficacy

Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy. (NCT02528188)
Timeframe: Baseline up to Week 56

Interventiondays (Median)
Tanezumab 2.5 mgNA
Tanezumab 5 mgNA
NSAIDNA

Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16

In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized. (NCT02528188)
Timeframe: Weeks 2, 4, 8 and 16

,,
Interventionmilligrams (Least Squares Mean)
Week 2Week 4Week 8Week 16
NSAID3310.52814.12839.72320.0
Tanezumab 2.5 mg2880.32107.81995.61696.4
Tanezumab 5 mg2898.71946.51628.81581.6

Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56

"An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - <1,500 counts) moderate (1,500 - <6,500 counts), and vigorous (>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A bout of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold." (NCT02528188)
Timeframe: Baseline, Weeks 16 and 56

,,
Interventionminutes (Median)
BaselineChange at Week 16Change at Week 56
NSAID0.00.00.0
Tanezumab 2.5 mg0.00.00.0
Tanezumab 5 mg0.00.0-1.4

Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56

An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {<1500} counts moderate (1,500 - <6500 counts), and vigorous (>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose). (NCT02528188)
Timeframe: Baseline, Weeks 16 and 56

,,
Interventionminutes (Median)
BaselineChange at Week 16Change at Week 56
NSAID41.9-0.17.4
Tanezumab 2.5 mg41.20.7-3.8
Tanezumab 5 mg53.1-1.62.7

Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56

Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose). (NCT02528188)
Timeframe: Baseline, Weeks 16 and 56

,,
Interventionminutes (Median)
BaselineChange at Week 16Change at Week 56
NSAID99.2-4.23.9
Tanezumab 2.5 mg97.03.9-8.9
Tanezumab 5 mg107.12.9-10.1

Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56

An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose). (NCT02528188)
Timeframe: Baseline, Weeks 16 and 56

,,
Interventionphysical activity counts (Median)
BaselineChange at Week 16Change at Week 56
NSAID744141202.94414.3
Tanezumab 2.5 mg75244-470.0-14552
Tanezumab 5 mg95911-2261-8313

Change From Baseline in Average Daily Step Count at Weeks 16 and 56

Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose). (NCT02528188)
Timeframe: Baseline, Weeks 16 and 56

,,
Interventionstep count (Median)
BaselineChange at Week 16Change at Week 56
NSAID4779.0-705.7242.6
Tanezumab 2.5 mg4851.0350.9-1938
Tanezumab 5 mg5834.887.8-543.2

Change From Baseline in Average Pain Score in the Index Joint at Week 64

Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score. (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 64
NSAID6.76-3.24
Tanezumab 2.5 mg6.76-3.01
Tanezumab 5 mg6.77-2.81

Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56

Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score. (NCT02528188)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 10Change at Week 12Change at Week 16Change at Week 20Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56
NSAID-0.56-0.91-1.23-1.32-1.49-1.59-1.98-2.10-2.17-2.27-2.11-2.06-2.07-2.03-2.04
Tanezumab 2.5 mg-0.47-1.02-1.40-1.62-1.85-1.83-2.35-2.48-2.41-2.56-2.35-2.27-2.25-2.20-2.17
Tanezumab 5 mg-0.56-0.97-1.30-1.65-1.97-2.04-2.46-2.55-2.52-2.60-2.41-2.26-2.20-2.10-2.03

Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP). (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

,,
Interventionmillimeters of mercury (mmHg) (Mean)
SBP: BaselineSBP: Change at Week 2SBP: Change at Week 4SBP: Change at Week 8SBP: Change at Week 16SBP: Change at Week 24SBP: Change at Week 32SBP: Change at Week 40SBP: Change at Week 48SBP: Change at Week 56SBP: Change at Week 64SBP: Change at Week 80DBP: BaselineDBP: Change at Week 2DBP: Change at Week 4DBP: Change at Week 8DBP: Change at Week 16DBP: Change at Week 24DBP: Change at Week 32DBP: Change at Week 40DBP: Change at Week 48DBP: Change at Week 56DBP: Change at Week 64DBP: Change at Week 80
NSAID128.8-1.2-1.8-1.8-1.3-1.7-1.7-2.3-2.2-2.2-2.8-2.379.3-1.1-1.4-1.1-1.1-1.4-1.2-1.1-1.5-1.2-1.7-1.2
Tanezumab 2.5 mg128.9-2.7-4.0-2.9-3.0-3.0-2.8-2.5-2.7-3.1-2.1-1.079.3-1.3-2.2-1.1-1.3-1.3-1.3-1.2-0.9-1.8-0.8-0.6
Tanezumab 5 mg129.3-4.2-4.9-3.8-3.7-3.1-3.3-3.8-3.0-3.4-2.1-1.379.1-2.1-2.5-1.7-1.8-1.7-1.4-2.0-1.8-1.9-0.8-0.6

Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80

A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms. (NCT02528188)
Timeframe: Baseline, Weeks 56 and 80

,,
Interventionmilliseconds (Mean)
RR Interval: BaselineRR Interval:Change at Week 56RR Interval:Change at Week 80PR Interval: BaselinePR Interval:Change at Week 56PR Interval:Change at Week 80QRS Interval: BaselineQRS Interval:Change at Week 56QRS Interval:Change at Week 80QT Interval: BaselineQT Interval:Change at Week 56QT Interval:Change at Week 80QTCB Interval: BaselineQTCB Interval:Change at Week 56QTCB Interval:Change at Week 80QTCF Interval: BaselineQTCF Interval:Change at Week 56QTCF Interval:Change at Week 80
NSAID936.1-14.9-34.3163.91.70.694.3-0.4-0.1404.3-2.9-6.0419.70.21.7414.3-0.8-1.0
Tanezumab 2.5 mg940.5-26.3-33.6165.01.70.394.90.2-0.2405.0-3.5-6.2419.32.31.5414.20.3-1.2
Tanezumab 5 mg940.1-22.6-32.4165.90.6-0.894.60.41.0403.8-4.5-6.8418.50.50.2413.3-1.2-2.1

Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80

Heart rate was measured at sitting position. (NCT02528188)
Timeframe: Baseline, Weeks 56 and 80

,,
Interventionbeats per minute (Mean)
BaselineChange at Week 56Change at Week 80
NSAID65.61.02.5
Tanezumab 2.5 mg65.22.02.7
Tanezumab 5 mg65.41.72.3

Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

Heart rate (pulse rate) was measured at sitting position. (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

,,
Interventionbeats per minute (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 16Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56Change at Week 64Change at Week 80
NSAID70.61.11.20.10.80.81.71.41.3-0.00.50.9
Tanezumab 2.5 mg70.81.81.60.70.50.41.21.20.60.21.50.9
Tanezumab 5 mg70.52.02.00.80.50.71.61.61.00.11.50.6

Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80

Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function. (NCT02528188)
Timeframe: Baseline, Weeks 56 and 80

,,
Interventionmillimeter (Least Squares Mean)
Change at Week 56Change at Week 80
NSAID-0.21-0.28
Tanezumab 2.5 mg-0.35-0.46
Tanezumab 5 mg-0.40-0.35

Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80

Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). (NCT02528188)
Timeframe: Baseline, Weeks 56 and 80

,,
Interventionmillimeter (Least Squares Mean)
Change in Medial JSW at Week 56Change in Medial JSW at Week 80Change in Lateral JSW at Week 56Change in Lateral JSW at Week 80
NSAID-0.19-0.25-0.27-0.37
Tanezumab 2.5 mg-0.25-0.33-0.26-0.46
Tanezumab 5 mg-0.34-0.37-0.32-0.32

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment. (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 16Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56Change at Week 64Change at Week 80
NSAID1.87-0.15-0.19-0.36-0.47-0.49-0.53-0.53-0.55-0.58-0.57-0.62
Tanezumab 2.5 mg1.85-0.22-0.16-0.27-0.27-0.32-0.37-0.35-0.37-0.35-0.32-0.35
Tanezumab 5 mg1.70-0.13-0.17-0.22-0.31-0.35-0.40-0.43-0.49-0.52-0.47-0.47

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64

"PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition." (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 64
NSAID3.44-0.95
Tanezumab 2.5 mg3.49-0.79
Tanezumab 5 mg3.46-0.64

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56

"PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition." (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56
NSAID-0.63-0.69-0.76-0.74-0.72-0.69-0.67-0.66
Tanezumab 2.5 mg-0.67-0.81-0.77-0.74-0.72-0.70-0.70-0.65
Tanezumab 5 mg-0.67-0.84-0.85-0.79-0.71-0.69-0.66-0.60

Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80

The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact. (NCT02528188)
Timeframe: Baseline, Weeks 24, 56 and 80

,,
Interventionunits on a scale (Mean)
Number of symptoms reported: BaselineNumber of symptoms reported: Change at Week 24Number of symptoms reported: Change at Week 56Number of symptoms reported: Change at Week 80Total symptom impact score: BaselineTotal symptom impact score: Change at Week 24Total symptom impact score: Change at Week 56Total symptom impact score: Change at Week 80
NSAID0.490.110.220.741.130.330.820.89
Tanezumab 2.5 mg0.470.210.280.891.100.660.971.33
Tanezumab 5 mg0.530.180.330.941.230.521.211.31

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response. (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 64
NSAID7.01-3.77
Tanezumab 2.5 mg7.09-3.40
Tanezumab 5 mg7.10-3.09

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response. (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 16Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56
NSAID-1.52-1.95-2.23-3.07-2.64-2.54-2.49-2.44-2.40
Tanezumab 2.5 mg-1.73-2.28-2.44-3.26-2.74-2.65-2.57-2.56-2.45
Tanezumab 5 mg-1.61-2.34-2.71-3.41-2.88-2.69-2.58-2.48-2.38

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64

"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain." (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 64
NSAID7.83-3.70
Tanezumab 2.5 mg7.89-3.28
Tanezumab 5 mg7.88-2.97

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain." (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 16Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56
NSAID-1.66-2.08-2.40-3.18-2.83-2.74-2.70-2.67-2.55
Tanezumab 2.5 mg-1.81-2.34-2.48-3.34-2.89-2.76-2.69-2.70-2.55
Tanezumab 5 mg-1.66-2.43-2.81-3.50-3.03-2.84-2.74-2.63-2.47

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64

"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain." (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 64
NSAID6.86-3.67
Tanezumab 2.5 mg6.86-3.20
Tanezumab 5 mg6.90-2.69

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain." (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 16Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56
NSAID-1.46-1.91-2.22-2.95-2.60-2.52-2.48-2.42-2.39
Tanezumab 2.5 mg-1.54-2.14-2.26-3.01-2.64-2.54-2.48-2.45-2.37
Tanezumab 5 mg-1.39-2.15-2.47-3.13-2.76-2.54-2.42-2.34-2.21

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 64
NSAID7.09-3.66
Tanezumab 2.5 mg7.15-3.31
Tanezumab 5 mg7.20-3.04

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 16Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56
NSAID-1.48-1.95-2.16-3.10-2.63-2.52-2.46-2.44-2.42
Tanezumab 2.5 mg-1.79-2.32-2.46-3.32-2.77-2.68-2.58-2.60-2.46
Tanezumab 5 mg-1.70-2.43-2.79-3.54-2.95-2.74-2.64-2.54-2.46

Change From Baseline in WOMAC Pain Subscale at Week 64

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 64
NSAID6.96-3.85
Tanezumab 2.5 mg7.01-3.47
Tanezumab 5 mg7.02-3.12

Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56

,,
Interventionunits on scale (Least Squares Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56
NSAID-1.55-1.98-2.27-2.67-2.57-2.52-2.47-2.42
Tanezumab 2.5 mg-1.65-2.25-2.41-2.73-2.64-2.56-2.54-2.44
Tanezumab 5 mg-1.49-2.29-2.65-2.86-2.68-2.57-2.48-2.37

Change From Baseline in WOMAC Physical Function Subscale at Week 64

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 64
NSAID6.99-3.81
Tanezumab 2.5 mg7.09-3.42
Tanezumab 5 mg7.08-3.12

Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 24Change at Week 32Change at Week 40Change at Week 48Change at Week 56
NSAID-1.55-1.96-2.27-2.66-2.55-2.50-2.45-2.41
Tanezumab 2.5 mg-1.76-2.29-2.46-2.78-2.66-2.56-2.56-2.45
Tanezumab 5 mg-1.64-2.31-2.69-2.88-2.67-2.57-2.49-2.36

Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64

WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. (NCT02528188)
Timeframe: Baseline, Week 64

,,
Interventionunits on a scale (Mean)
Baseline: Percent Work Time MissedBaseline: Percent Impairment While WorkingBaseline: Percent Overall Work ImpairmentBaseline: Percent Activity ImpairmentChange at Week 64: Percent Work Time MissedChange at Week 64:Percent Impairment While WorkingChange at Week 64: Percent Overall Work ImpairmentChange at Week 64: Percent Activity Impairment
NSAID5.259.360.666.7-2.1-26.5-27.0-32.1
Tanezumab 2.5 mg6.160.562.168.3-1.8-24.2-24.5-28.7
Tanezumab 5 mg6.058.360.067.94.1-20.7-19.2-24.1

Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56

WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. (NCT02528188)
Timeframe: Weeks 16, 24 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 16: Percent Work Time MissedChange at Week 16:Percent Impairment While WorkingChange at Week 16: Percent Overall Work ImpairmentChange at Week 16: Percent Activity ImpairmentChange at Week 24: Percent Work Time MissedChange at Week 24:Percent Impairment While WorkingChange at Week 24: Percent Overall Work ImpairmentChange at Week 24: Percent Activity ImpairmentChange at Week 56: Percent Work Time MissedChange at Week 56:Percent Impairment While WorkingChange at Week 56: Percent Overall Work ImpairmentChange at Week 56: Percent Activity Impairment
NSAID-2.92-26.59-27.04-29.38-2.73-25.15-25.90-29.76-0.81-34.59-34.26-36.17
Tanezumab 2.5 mg-2.33-28.07-28.67-30.59-2.70-25.34-26.05-29.88-0.12-31.49-31.21-34.47
Tanezumab 5 mg-3.35-26.94-27.51-31.36-2.19-26.66-27.33-30.53-1.84-29.92-29.29-32.91

European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value

EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions. (NCT02528188)
Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

,,
Interventionunits on a scale (Mean)
BaselineWeek 8Week 16Week 24Week 40Week 56Week 64
NSAID0.620.740.770.770.800.790.75
Tanezumab 2.5 mg0.610.740.770.760.790.780.72
Tanezumab 5 mg0.610.750.780.760.780.770.69

Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

,,
Interventionyears (Median)
BaselineWeek 64Week 80
NSAID2.44.01.8
Tanezumab 2.5 mg2.02.42.0
Tanezumab 5 mg1.81.82.0

Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

Interventionnights (Median)
BaselineWeek 64
NSAID11.02.0

Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

,
Interventionnights (Median)
BaselineWeek 64Week 80
Tanezumab 2.5 mg12.02.02.0
Tanezumab 5 mg9.02.02.0

Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

,,
InterventionParticipants (Count of Participants)
BaselineWeek 64Week 80
NSAID160
Tanezumab 2.5 mg1158
Tanezumab 5 mg61112

Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

,,
InterventionParticipants (Count of Participants)
BaselineWeek 64Week 80
NSAID65266
Tanezumab 2.5 mg472812
Tanezumab 5 mg553518

Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

,,
InterventionParticipants (Count of Participants)
BaselineWeek 64Week 80
NSAID1152
Tanezumab 2.5 mg15104
Tanezumab 5 mg23155

Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

,,
Interventionvisits (Median)
Baseline: Primary Care PhysicianBaseline: NeurologistBaseline: RheumatologistBaseline:Physician Assistant or Nurse PractitionerBaseline: Pain SpecialistBaseline: OrthopedistBaseline: Physical TherapistBaseline: ChiropractorBaseline: Alternative Medicine or TherapyBaseline: PodiatristBaseline: Nutritionist/DietitianBaseline: RadiologistBaseline: Home Healthcare ServicesBaseline: Other PractitionerWeek 64: Primary Care PhysicianWeek 64: NeurologistWeek 64: RheumatologistWeek 64: Physician Assistant Or Nurse PractitionerWeek 64: Pain SpecialistWeek 64: OrthopedistWeek 64: Physical TherapistWeek 64: ChiropractorWeek 64: Alternative Medicine or TherapyWeek 64: PodiatristWeek 64: Nutritionist/DietitianWeek 64: RadiologistWeek 64: Home Healthcare ServicesWeek 64: Other PractitionerWeek 80: Primary Care PhysicianWeek 80: NeurologistWeek 80: RheumatologistWeek 80: Physician Assistant or Nurse PractitionerWeek 80: Pain SpecialistWeek 80: OrthopedistWeek 80: Physical TherapistWeek 80: ChiropractorWeek 80: Alternative Medicine or TherapyWeek 80: PodiatristWeek 80: Nutritionist/DietitianWeek 80: RadiologistWeek 80: Home Healthcare ServicesWeek 80: Other Practitioner
NSAID1.01.02.01.01.02.03.03.02.01.01.01.03.02.01.01.01.02.01.01.03.03.02.01.01.01.05.01.01.01.01.01.01.01.03.03.02.03.01.01.01.01.0
Tanezumab 2.5 mg1.01.01.01.01.02.04.03.02.01.01.01.02.02.01.01.01.01.01.01.04.03.01.01.02.01.04.01.01.01.01.01.01.51.58.03.03.51.01.01.02.51.0
Tanezumab 5 mg1.01.02.01.02.01.03.03.02.01.01.01.01.02.01.01.01.01.01.01.04.52.02.01.01.01.04.01.01.01.01.01.02.01.05.54.51.01.01.51.04.01.0

Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

,,
Interventionvisits (Median)
BaselineWeek 64Week 80
NSAID1.01.01.0
Tanezumab 2.5 mg1.01.01.0
Tanezumab 5 mg1.01.03.0

Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized. (NCT02528188)
Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

,,
Interventiondays (Least Squares Mean)
Week 2Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 56
NSAID2.261.861.651.391.651.781.761.741.74
Tanezumab 2.5 mg2.311.801.651.291.561.671.701.681.73
Tanezumab 5 mg2.291.701.421.251.561.661.711.761.85

Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized. (NCT02528188)
Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56

,,
InterventionParticipants (Count of Participants)
Week 2Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 56
NSAID527469418352384390388389397
Tanezumab 2.5 mg567481433353372391391391391
Tanezumab 5 mg548437377330358380388393408

Number of Participants With Anti-Tanezumab Antibodies

Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). (NCT02528188)
Timeframe: Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80

,
InterventionParticipants (Count of Participants)
BaselineWeek 8Week 16Week 32Week 48Week 56Week 64Week 80
Tanezumab 2.5 mg1161209810896826950
Tanezumab 5 mg8393838178666042

Number of Participants With Confirmed Orthostatic Hypotension

Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. (NCT02528188)
Timeframe: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80

,,
InterventionParticipants (Count of Participants)
BaselineWeek 2Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 56Week 64Week 80
NSAID122101010130
Tanezumab 2.5 mg021010212100
Tanezumab 5 mg341211212111

Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80

Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW >=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function. (NCT02528188)
Timeframe: Weeks 56 and 80

,,
InterventionParticipants (Count of Participants)
Week 56Week 80
NSAID33
Tanezumab 2.5 mg109
Tanezumab 5 mg109

Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80

Progression of OA according to Bland-Altman as defined by a decrease JSW >=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function. (NCT02528188)
Timeframe: Weeks 56 and 80

,,
InterventionParticipants (Count of Participants)
Decreased medial JSW at Week 56Decreased medial JSW at Week 80Decreased lateral JSW at Week 56Decreased lateral JSW at Week 80
NSAID201697
Tanezumab 2.5 mg332959
Tanezumab 5 mg433884

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs. (NCT02528188)
Timeframe: Baseline up to Week 80

,,
InterventionParticipants (Count of Participants)
AEsSAEs
NSAID66666
Tanezumab 2.5 mg68178
Tanezumab 5 mg744110

Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. (NCT02528188)
Timeframe: Baseline up to Week 80

,,
InterventionParticipants (Count of Participants)
Treatment Related AEsTreatment Related SAEs
NSAID1797
Tanezumab 2.5 mg1907
Tanezumab 5 mg25020

Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome

Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk. (NCT02528188)
Timeframe: Baseline up to Week 80

,,
Interventionevents per 1000 participant-years (Number)
Rapidly Progressive OA Type 1 or 2Rapidly Progressive OA Type 1Rapidly Progressive OA Type 2Primary OsteonecrosisPathological FractureSubchondral Insufficiency Fracture
NSAID11.910.91.0003.9
Tanezumab 2.5 mg31.428.42.91.005.8
Tanezumab 5 mg63.349.113.91.006.9

Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

"PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF." (NCT02528188)
Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 56Week 64
NSAID11.615.919.028.223.723.621.021.120.825.8
Tanezumab 2.5 mg14.621.421.929.123.423.721.722.021.021.1
Tanezumab 5 mg15.622.423.730.324.822.321.721.719.717.4

Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

Percentage of participants with reduction in WOMAC pain intensity of >= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF. (NCT02528188)
Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

,,
Interventionpercentage of participants (Number)
Week 2: At least 30% reductionWeek 2: At least 50% reductionWeek 2: At least 70% reductionWeek 2: At least 90% reductionWeek 4: At least 30% reductionWeek 4: At least 50% reductionWeek 4: At least 70% reductionWeek 4: At least 90% reductionWeek 8: At least 30% reductionWeek 8: At least 50% reductionWeek 8: At least 70% reductionWeek 8: At least 90% reductionWeek 16: At least 30% reductionWeek 16: At least 50% reductionWeek 16: At least 70% reductionWeek 16: At least 90% reductionWeek 24: At least 30% reductionWeek 24: At least 50% reductionWeek 24: At least 70% reductionWeek 24: At least 90% reductionWeek 32: At least 30% reductionWeek 32: At least 50% reductionWeek 32: At least 70% reductionWeek 32: At least 90% reductionWeek 40: At least 30% reductionWeek 40: At least 50% reductionWeek 40: At least 70% reductionWeek 40: At least 90% reductionWeek 48: At least 30% reductionWeek 48: At least 50% reductionWeek 48: At least 70% reductionWeek 48: At least 90% reductionWeek 56: At least 30% reductionWeek 56: At least 50% reductionWeek 56: At least 70% reductionWeek 56: At least 90% reductionWeek 64: At least 30% reductionWeek 64: At least 50% reductionWeek 64: At least 70% reductionWeek 64: At least 90% reduction
NSAID32.414.76.21.844.424.911.93.154.132.615.94.268.951.528.88.559.447.529.011.556.346.327.410.054.846.029.310.454.244.428.510.652.743.527.510.181.360.234.212.6
Tanezumab 2.5 mg34.817.87.72.450.230.414.54.355.936.819.34.771.854.928.910.359.449.330.810.356.847.431.210.355.747.230.010.854.646.229.610.353.144.328.210.173.055.431.19.6
Tanezumab 5 mg30.516.57.12.549.530.516.44.959.039.322.46.672.956.535.012.761.149.433.813.355.745.831.512.954.645.230.412.052.943.229.411.451.241.527.010.569.047.324.37.9

Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

Percentage of participants with reduction in WOMAC physical function of >=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF. (NCT02528188)
Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

,,
Interventionpercentage of participants (Number)
Week 2: At least 30% reductionWeek 2: At least 50% reductionWeek 2: At least 70% reductionWeek 2: At least 90% reductionWeek 4: At least 30% reductionWeek 4: At least 50% reductionWeek 4: At least 70% reductionWeek 4: At least 90% reductionWeek 8: At least 30% reductionWeek 8: At least 50% reductionWeek 8: At least 70% reductionWeek 8: At least 90% reductionWeek 16: At least 30% reductionWeek 16: At least 50% reductionWeek 16: At least 70% reductionWeek 16: At least 90% reductionWeek 24: At least 30% reductionWeek 24: At least 50% reductionWeek 24: At least 70% reductionWeek 24: At least 90% reductionWeek 32: At least 30% reductionWeek 32: At least 50% reductionWeek 32: At least 70% reductionWeek 32: At least 90% reductionWeek 40: At least 30% reductionWeek 40: At least 50% reductionWeek 40: At least 70% reductionWeek 40: At least 90% reductionWeek 48: At least 30% reductionWeek 48: At least 50% reductionWeek 48: At least 70% reductionWeek 48: At least 90% reductionWeek 56: At least 30% reductionWeek 56: At least 50% reductionWeek 56: At least 70% reductionWeek 56: At least 90% reductionWeek 64: At least 30% reductionWeek 64: At least 50% reductionWeek 64: At least 70% reductionWeek 64: At least 90% reduction
NSAID31.715.45.81.743.223.111.22.655.031.414.14.468.150.127.99.759.046.827.89.855.944.726.89.454.945.027.69.554.643.426.19.452.942.526.09.078.258.933.913.3
Tanezumab 2.5 mg35.820.08.32.149.031.115.54.656.036.618.75.871.653.129.910.759.549.930.411.056.747.229.711.055.545.529.510.354.545.329.110.252.044.126.99.371.452.931.49.4
Tanezumab 5 mg32.117.08.23.249.131.315.85.459.540.021.37.171.855.834.313.461.348.232.713.056.645.730.213.155.545.029.113.253.343.527.912.051.141.326.410.568.044.622.97.9

Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was >=50 percent and >= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of OA (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF). (NCT02528188)
Timeframe: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64

,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 56Week 64
NSAID44.856.464.475.161.358.658.257.356.086.5
Tanezumab 2.5 mg46.762.667.578.262.459.258.457.456.579.2
Tanezumab 5 mg43.762.770.378.364.859.958.756.254.575.2

Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than [>] 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF. (NCT02528188)
Timeframe: Baseline, Weeks 16, 24 and 56

,,
Interventionpercentage of participants (Number)
Week 16: >0%Week 16: >=10%Week 16: >=20%Week 16: >=30%Week 16: >=40%Week 16: >=50%Week 16: >=60%Week 16: >=70%Week 16: >=80%Week 16: >=90%Week 16: =100%Week 24: >0%Week 24: >=10%Week 24: >=20%Week 24: >=30%Week 24: >=40%Week 24: >=50%Week 24: >=60%Week 24: >=70%Week 24: >=80%Week 24: >=90%Week 24: =100%Week 56: >0%Week 56: >=10%Week 56: >=20%Week 56: >=30%Week 56: >=40%Week 56: >=50%Week 56: >=60%Week 56: >=70%Week 56: >=80%Week 56: >=90%Week 56: =100%
NSAID87.182.875.868.959.951.538.828.818.88.53.364.863.462.159.454.747.538.129.020.211.53.459.758.156.352.748.643.536.327.518.610.14.1
Tanezumab 2.5 mg89.585.078.171.863.754.940.928.919.410.34.466.764.962.259.455.249.340.730.820.610.33.960.859.155.953.148.644.337.028.218.910.14.5
Tanezumab 5 mg87.682.878.372.963.556.544.835.023.912.73.968.266.465.261.155.749.441.233.824.013.34.559.157.054.851.246.841.533.827.019.110.55.3

Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56

Percentage of participants with cumulative reduction (as percent) (> 0 %; >= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF. (NCT02528188)
Timeframe: Baseline, Weeks 16, 24 and 56

,,
Interventionpercentage of participants (Number)
Week 16: >0%Week 16: >=10%Week 16: >=20%Week 16: >=30%Week 16: >=40%Week 16: >=50%Week 16: >=60%Week 16: >=70%Week 16: >=80%Week 16: >=90%Week 16: =100%Week 24: >0%Week 24: >=10%Week 24: >=20%Week 24: >=30%Week 24: >=40%Week 24: >=50%Week 24: >=60%Week 24: >=70%Week 24: >=80%Week 24: >=90%Week 24: =100%Week 56: >0%Week 56: >=10%Week 56: >=20%Week 56: >=30%Week 56: >=40%Week 56: >=50%Week 56: >=60%Week 56: >=70%Week 56: >=80%Week 56: >=90%Week 56: =100%
NSAID87.481.473.768.161.050.139.827.917.99.72.065.063.360.859.053.946.837.727.818.99.82.760.157.855.452.948.942.534.826.017.49.03.3
Tanezumab 2.5 mg90.085.078.471.663.753.141.429.920.810.72.966.765.062.659.554.949.941.330.419.911.03.061.159.356.152.048.544.136.726.917.19.32.9
Tanezumab 5 mg88.883.977.371.864.155.844.734.324.413.43.368.666.664.261.356.048.242.032.722.613.03.259.557.354.351.146.341.334.626.417.110.53.6

Percentage of Participants With Individual Adjudicated Joint Safety Outcome

Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW >=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA. (NCT02528188)
Timeframe: Baseline up to Week 80

,,
Interventionpercentage of participants (Number)
Rapidly Progressive OA Type 1 or 2Rapidly Progressive OA type 1Rapidly Progressive OA type 2Primary OsteonecrosisPathological FractureSubchondral Insufficiency Fracture
NSAID1.21.10.1000.4
Tanezumab 2.5 mg3.22.90.30.100.6
Tanezumab 5 mg6.34.91.40.100.7

Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses

TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied] and 1 question on 2 point scale [0 =No, 1=Yes]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction. (NCT02528188)
Timeframe: Weeks 16 and 56

,,
Interventionunits on a scale (Least Squares Mean)
Week 16: EffectivenessWeek 16: Side EffectsWeek 16: ConvenienceWeek 16: Global SatisfactionWeek 56: EffectivenessWeek 56: Side EffectsWeek 56: ConvenienceWeek 56: Global Satisfaction
NSAID61.6171.0373.7067.1367.6471.3476.1873.37
Tanezumab 2.5 mg64.2668.6175.5070.3269.7978.6278.0375.31
Tanezumab 5 mg66.2773.3275.7870.6967.9162.0077.6773.37

Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis

OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices. (NCT02528188)
Timeframe: Baseline, Weeks 64 and 80

InterventionParticipants (Count of Participants)
Baseline: Walking Aid Use72578291Baseline: Walking Aid Use72578290Baseline: Walking Aid Use72578289Baseline: Wheelchair Use72578291Baseline: Wheelchair Use72578289Baseline: Wheelchair Use72578290Baseline: Device/Utensil to Dress Bathe Eat72578289Baseline: Device/Utensil to Dress Bathe Eat72578291Baseline: Device/Utensil to Dress Bathe Eat72578290Baseline: Other Aids Or Devices72578289Baseline: Other Aids Or Devices72578290Baseline: Other Aids Or Devices72578291Week 64: Walking Aid Use72578290Week 64: Walking Aid Use72578289Week 64: Walking Aid Use72578291Week 64: Wheelchair Use72578291Week 64: Wheelchair Use72578290Week 64: Wheelchair Use72578289Week 64: Device/Utensil to Dress Bathe Eat72578291Week 64: Device/Utensil to Dress Bathe Eat72578289Week 64: Device/Utensil to Dress Bathe Eat72578290Week 64: Other Aids Or Devices72578289Week 64: Other Aids Or Devices72578291Week 64: Other Aids Or Devices72578290Week 80: Walking Aid Use72578289Week 80: Walking Aid Use72578291Week 80: Walking Aid Use72578290Week 80: Wheelchair Use72578291Week 80: Wheelchair Use72578289Week 80: Wheelchair Use72578290Week 80: Device/Utensil to Dress Bathe Eat72578290Week 80: Device/Utensil to Dress Bathe Eat72578289Week 80: Device/Utensil to Dress Bathe Eat72578291Week 80: Other Aids Or Devices72578291Week 80: Other Aids Or Devices72578289Week 80: Other Aids Or Devices72578290
NeverRarelySometimesAlwaysOften
Tanezumab 2.5 mg852
Tanezumab 5 mg838
NSAID851
Tanezumab 5 mg18
NSAID24
Tanezumab 2.5 mg71
Tanezumab 5 mg69
NSAID75
Tanezumab 2.5 mg32
Tanezumab 5 mg43
NSAID26
Tanezumab 5 mg29
NSAID19
Tanezumab 2.5 mg992
Tanezumab 5 mg989
NSAID988
NSAID1
Tanezumab 2.5 mg970
Tanezumab 5 mg976
NSAID977
NSAID0
Tanezumab 2.5 mg7
NSAID6
Tanezumab 2.5 mg16
NSAID7
Tanezumab 2.5 mg6
NSAID5
Tanezumab 2.5 mg932
Tanezumab 5 mg935
NSAID921
NSAID9
Tanezumab 2.5 mg27
NSAID41
NSAID14
NSAID10
Tanezumab 2.5 mg662
Tanezumab 5 mg662
NSAID714
Tanezumab 2.5 mg21
Tanezumab 5 mg9
NSAID12
Tanezumab 2.5 mg48
Tanezumab 5 mg47
NSAID37
Tanezumab 2.5 mg20
Tanezumab 5 mg30
NSAID17
Tanezumab 2.5 mg22
Tanezumab 5 mg34
Tanezumab 2.5 mg765
Tanezumab 5 mg776
NSAID794
Tanezumab 2.5 mg760
Tanezumab 5 mg768
NSAID792
NSAID2
Tanezumab 2.5 mg733
Tanezumab 5 mg720
NSAID771
NSAID11
Tanezumab 2.5 mg19
Tanezumab 5 mg26
NSAID8
Tanezumab 5 mg20
Tanezumab 5 mg7
NSAID3
Tanezumab 2.5 mg373
Tanezumab 5 mg322
NSAID386
Tanezumab 2.5 mg12
Tanezumab 5 mg10
Tanezumab 2.5 mg25
Tanezumab 5 mg25
Tanezumab 2.5 mg14
Tanezumab 5 mg17
Tanezumab 2.5 mg8
Tanezumab 5 mg22
Tanezumab 2.5 mg430
Tanezumab 5 mg389
NSAID421
Tanezumab 2.5 mg0
Tanezumab 2.5 mg1
Tanezumab 5 mg1
Tanezumab 2.5 mg425
Tanezumab 5 mg383
NSAID422
Tanezumab 5 mg0
Tanezumab 5 mg6
Tanezumab 2.5 mg3
Tanezumab 5 mg5
Tanezumab 5 mg2
Tanezumab 2.5 mg416
Tanezumab 5 mg375
NSAID410
Tanezumab 2.5 mg4
NSAID4
Tanezumab 5 mg11
Tanezumab 2.5 mg5
Tanezumab 5 mg4
Tanezumab 2.5 mg2
Tanezumab 5 mg3

Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80

The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change >0), No change and worsening (Change less than [<] 0). (NCT02528188)
Timeframe: Baseline, Weeks 4, 8, 16, 24, 56 and 80

InterventionParticipants (Count of Participants)
Change at Week 472578289Change at Week 472578291Change at Week 472578290Change at Week 872578290Change at Week 872578291Change at Week 872578289Change at Week 1672578290Change at Week 1672578291Change at Week 1672578289Change at Week 2472578289Change at Week 2472578290Change at Week 2472578291Change at Week 5672578289Change at Week 5672578291Change at Week 5672578290Change at Week 8072578289Change at Week 8072578290Change at Week 8072578291
ImprovementNo ChangeWorsening
Tanezumab 2.5 mg423
Tanezumab 5 mg421
NSAID411
Tanezumab 2.5 mg370
Tanezumab 5 mg394
NSAID369
Tanezumab 2.5 mg207
Tanezumab 5 mg180
NSAID214
Tanezumab 2.5 mg454
Tanezumab 5 mg443
NSAID445
Tanezumab 2.5 mg325
Tanezumab 5 mg362
NSAID348
Tanezumab 2.5 mg221
Tanezumab 5 mg190
NSAID201
Tanezumab 2.5 mg488
Tanezumab 5 mg470
NSAID477
Tanezumab 2.5 mg288
Tanezumab 5 mg312
NSAID312
Tanezumab 2.5 mg224
Tanezumab 5 mg213
NSAID205
Tanezumab 2.5 mg478
Tanezumab 5 mg458
NSAID467
Tanezumab 2.5 mg277
Tanezumab 5 mg302
NSAID291
Tanezumab 2.5 mg245
Tanezumab 5 mg235
NSAID236
Tanezumab 2.5 mg486
Tanezumab 5 mg429
NSAID461
Tanezumab 2.5 mg270
Tanezumab 5 mg314
NSAID300
Tanezumab 2.5 mg244
Tanezumab 5 mg252
NSAID233
Tanezumab 2.5 mg220
Tanezumab 5 mg196
NSAID227
Tanezumab 2.5 mg105
Tanezumab 5 mg97
NSAID125
Tanezumab 2.5 mg113
Tanezumab 5 mg115
NSAID80

Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain

Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. (NCT02528188)
Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

InterventionParticipants (Count of Participants)
Baseline72578289Baseline72578290Baseline72578291Week 872578290Week 872578291Week 872578289Week 1672578289Week 1672578290Week 1672578291Week 2472578291Week 2472578289Week 2472578290Week 4072578289Week 4072578290Week 4072578291Week 5672578289Week 5672578290Week 5672578291Week 6472578289Week 6472578290Week 6472578291
Severely anxious or depressedExtremely anxious or depressedNot anxious or depressedSlightly anxious or depressedModerately anxious or depressed
Tanezumab 2.5 mg560
Tanezumab 5 mg570
NSAID585
Tanezumab 2.5 mg252
Tanezumab 5 mg235
NSAID236
Tanezumab 2.5 mg155
Tanezumab 5 mg151
NSAID144
Tanezumab 2.5 mg28
Tanezumab 5 mg37
NSAID26
Tanezumab 2.5 mg5
NSAID3
Tanezumab 2.5 mg693
Tanezumab 5 mg703
NSAID664
Tanezumab 2.5 mg189
Tanezumab 5 mg180
NSAID206
Tanezumab 2.5 mg64
Tanezumab 5 mg71
NSAID75
Tanezumab 2.5 mg9
Tanezumab 5 mg7
NSAID9
Tanezumab 5 mg5
Tanezumab 2.5 mg680
Tanezumab 5 mg701
NSAID701
Tanezumab 2.5 mg170
Tanezumab 5 mg147
NSAID151
Tanezumab 2.5 mg53
Tanezumab 5 mg62
NSAID53
NSAID8
Tanezumab 2.5 mg2
Tanezumab 5 mg4
NSAID2
Tanezumab 2.5 mg611
Tanezumab 5 mg606
NSAID599
Tanezumab 2.5 mg147
Tanezumab 5 mg131
Tanezumab 2.5 mg52
Tanezumab 5 mg66
NSAID58
Tanezumab 2.5 mg7
Tanezumab 5 mg10
NSAID11
Tanezumab 2.5 mg0
Tanezumab 5 mg3
NSAID1
Tanezumab 2.5 mg442
Tanezumab 5 mg429
NSAID400
Tanezumab 2.5 mg92
Tanezumab 5 mg82
NSAID107
Tanezumab 2.5 mg24
Tanezumab 5 mg35
NSAID21
Tanezumab 2.5 mg3
Tanezumab 5 mg6
NSAID7
Tanezumab 5 mg1
NSAID0
Tanezumab 2.5 mg351
Tanezumab 5 mg330
NSAID338
Tanezumab 2.5 mg88
Tanezumab 5 mg90
NSAID86
Tanezumab 2.5 mg18
Tanezumab 5 mg33
NSAID34
Tanezumab 2.5 mg1
Tanezumab 5 mg2
Tanezumab 2.5 mg308
Tanezumab 5 mg275
NSAID315
Tanezumab 2.5 mg104
Tanezumab 5 mg96
NSAID100
Tanezumab 2.5 mg29
Tanezumab 5 mg46
Tanezumab 2.5 mg8
Tanezumab 5 mg9
NSAID5

Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain

Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. (NCT02528188)
Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

InterventionParticipants (Count of Participants)
Baseline72578290Baseline72578289Baseline72578291Week 872578290Week 872578291Week 872578289Week 1672578289Week 1672578290Week 1672578291Week 2472578289Week 2472578290Week 2472578291Week 4072578289Week 4072578290Week 4072578291Week 5672578289Week 5672578290Week 5672578291Week 6472578289Week 6472578290Week 6472578291
Severe problem in walkingModerate problem in walkingNo problem in walkingSlight problem in walkingUnable to walk
Tanezumab 2.5 mg26
Tanezumab 5 mg20
NSAID23
Tanezumab 2.5 mg203
Tanezumab 5 mg192
NSAID194
Tanezumab 2.5 mg567
Tanezumab 5 mg579
NSAID588
Tanezumab 2.5 mg204
Tanezumab 5 mg202
Tanezumab 2.5 mg0
Tanezumab 2.5 mg223
Tanezumab 5 mg241
NSAID216
Tanezumab 2.5 mg374
Tanezumab 5 mg411
NSAID392
Tanezumab 2.5 mg318
Tanezumab 5 mg266
NSAID301
Tanezumab 2.5 mg41
Tanezumab 5 mg48
NSAID44
Tanezumab 5 mg0
NSAID3
Tanezumab 2.5 mg299
Tanezumab 5 mg319
NSAID292
Tanezumab 2.5 mg388
Tanezumab 5 mg371
NSAID412
Tanezumab 2.5 mg199
Tanezumab 5 mg196
NSAID185
Tanezumab 2.5 mg27
Tanezumab 5 mg34
NSAID26
Tanezumab 2.5 mg259
Tanezumab 5 mg261
NSAID260
Tanezumab 2.5 mg308
Tanezumab 5 mg310
NSAID337
Tanezumab 2.5 mg216
Tanezumab 5 mg200
NSAID186
Tanezumab 2.5 mg34
Tanezumab 5 mg43
NSAID29
Tanezumab 5 mg2
NSAID1
Tanezumab 2.5 mg217
Tanezumab 5 mg211
NSAID218
Tanezumab 2.5 mg215
Tanezumab 5 mg209
NSAID217
Tanezumab 2.5 mg110
Tanezumab 5 mg106
Tanezumab 5 mg27
Tanezumab 2.5 mg157
Tanezumab 5 mg147
NSAID170
Tanezumab 2.5 mg205
Tanezumab 5 mg166
NSAID189
Tanezumab 2.5 mg77
Tanezumab 5 mg120
NSAID91
Tanezumab 2.5 mg19
Tanezumab 5 mg24
NSAID9
Tanezumab 2.5 mg98
Tanezumab 5 mg66
NSAID107
Tanezumab 2.5 mg156
Tanezumab 5 mg156
NSAID205
Tanezumab 2.5 mg150
Tanezumab 5 mg151
NSAID121
Tanezumab 2.5 mg45
Tanezumab 5 mg54
NSAID21
Tanezumab 2.5 mg1
Tanezumab 5 mg1
NSAID0

Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain

Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. (NCT02528188)
Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

InterventionParticipants (Count of Participants)
Baseline72578289Baseline72578290Baseline72578291Week 872578291Week 872578290Week 872578289Week 1672578290Week 1672578289Week 1672578291Week 2472578289Week 2472578290Week 2472578291Week 4072578290Week 4072578289Week 4072578291Week 5672578289Week 5672578290Week 5672578291Week 6472578289Week 6472578290Week 6472578291
Slight pain or discomfortModerate pain or discomfortSevere pain or discomfortExtreme pain or discomfortNo pain or discomfort
Tanezumab 2.5 mg6
NSAID5
Tanezumab 2.5 mg81
Tanezumab 5 mg75
NSAID86
Tanezumab 2.5 mg548
Tanezumab 5 mg574
NSAID588
Tanezumab 2.5 mg334
Tanezumab 5 mg314
NSAID295
Tanezumab 2.5 mg31
Tanezumab 5 mg28
NSAID20
Tanezumab 2.5 mg82
Tanezumab 5 mg102
NSAID83
Tanezumab 2.5 mg433
Tanezumab 5 mg465
NSAID434
Tanezumab 2.5 mg369
Tanezumab 5 mg327
NSAID365
Tanezumab 2.5 mg68
Tanezumab 5 mg68
NSAID71
NSAID3
Tanezumab 2.5 mg128
Tanezumab 5 mg163
NSAID131
Tanezumab 2.5 mg508
Tanezumab 5 mg482
NSAID515
Tanezumab 2.5 mg235
Tanezumab 5 mg225
NSAID217
Tanezumab 2.5 mg39
Tanezumab 5 mg44
NSAID46
Tanezumab 2.5 mg3
Tanezumab 5 mg6
NSAID6
Tanezumab 2.5 mg117
Tanezumab 5 mg148
NSAID130
Tanezumab 2.5 mg413
Tanezumab 5 mg384
NSAID413
Tanezumab 2.5 mg213
Tanezumab 5 mg218
NSAID215
Tanezumab 2.5 mg70
Tanezumab 5 mg62
NSAID51
Tanezumab 2.5 mg4
Tanezumab 5 mg4
NSAID4
Tanezumab 2.5 mg97
Tanezumab 5 mg122
NSAID110
Tanezumab 2.5 mg298
Tanezumab 5 mg264
NSAID308
Tanezumab 2.5 mg139
Tanezumab 5 mg130
NSAID104
Tanezumab 2.5 mg25
Tanezumab 5 mg30
NSAID13
Tanezumab 2.5 mg2
Tanezumab 5 mg7
NSAID0
Tanezumab 2.5 mg76
Tanezumab 5 mg90
NSAID85
Tanezumab 2.5 mg248
Tanezumab 5 mg211
NSAID259
Tanezumab 2.5 mg111
Tanezumab 5 mg128
NSAID103
Tanezumab 2.5 mg23
Tanezumab 5 mg26
NSAID9
Tanezumab 2.5 mg0
Tanezumab 5 mg3
Tanezumab 2.5 mg45
Tanezumab 5 mg35
NSAID62
Tanezumab 2.5 mg169
Tanezumab 5 mg115
NSAID191
Tanezumab 2.5 mg165
Tanezumab 5 mg191
NSAID171
Tanezumab 2.5 mg66
Tanezumab 5 mg76
NSAID29
Tanezumab 2.5 mg5
Tanezumab 5 mg11
NSAID1

Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain

Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. (NCT02528188)
Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

InterventionParticipants (Count of Participants)
Baseline72578289Baseline72578290Baseline72578291Week 872578289Week 872578290Week 872578291Week 1672578289Week 1672578290Week 1672578291Week 2472578289Week 2472578290Week 2472578291Week 4072578289Week 4072578290Week 4072578291Week 5672578289Week 5672578290Week 5672578291Week 6472578289Week 6472578290Week 6472578291
Unable to wash or dressSlight problems washing or dressingModerate problems washing or dressingSevere problems washing or dressingNo problems washing or dressing
Tanezumab 2.5 mg251
Tanezumab 5 mg242
NSAID270
Tanezumab 2.5 mg315
Tanezumab 5 mg295
NSAID319
Tanezumab 2.5 mg361
Tanezumab 5 mg389
NSAID350
Tanezumab 2.5 mg73
Tanezumab 5 mg69
NSAID55
Tanezumab 2.5 mg551
Tanezumab 5 mg569
NSAID542
Tanezumab 2.5 mg270
Tanezumab 5 mg261
NSAID276
Tanezumab 2.5 mg126
Tanezumab 5 mg128
NSAID134
Tanezumab 2.5 mg8
Tanezumab 5 mg8
NSAID3
Tanezumab 2.5 mg1
Tanezumab 2.5 mg610
Tanezumab 5 mg597
NSAID583
Tanezumab 2.5 mg216
Tanezumab 5 mg231
NSAID246
Tanezumab 2.5 mg81
Tanezumab 5 mg87
NSAID77
Tanezumab 2.5 mg6
Tanezumab 5 mg5
NSAID9
Tanezumab 2.5 mg0
Tanezumab 2.5 mg504
Tanezumab 5 mg504
NSAID527
Tanezumab 2.5 mg214
Tanezumab 5 mg200
NSAID192
Tanezumab 2.5 mg91
Tanezumab 5 mg102
NSAID86
Tanezumab 2.5 mg7
Tanezumab 5 mg9
NSAID8
Tanezumab 5 mg1
Tanezumab 2.5 mg377
Tanezumab 5 mg359
NSAID371
Tanezumab 2.5 mg140
NSAID125
Tanezumab 5 mg54
NSAID38
Tanezumab 5 mg4
NSAID0
Tanezumab 2.5 mg305
Tanezumab 5 mg294
NSAID291
Tanezumab 2.5 mg107
Tanezumab 5 mg115
NSAID122
Tanezumab 2.5 mg42
Tanezumab 5 mg47
NSAID40
Tanezumab 2.5 mg3
Tanezumab 5 mg2
NSAID5
NSAID1
Tanezumab 2.5 mg233
Tanezumab 5 mg192
NSAID264
Tanezumab 2.5 mg142
Tanezumab 5 mg136
NSAID131
Tanezumab 2.5 mg66
Tanezumab 5 mg89
NSAID57
Tanezumab 5 mg11
NSAID2
Tanezumab 5 mg0

Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain

Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions. (NCT02528188)
Timeframe: Baseline, Weeks 8, 16, 24, 40, 56 and 64

InterventionParticipants (Count of Participants)
Baseline72578290Baseline72578289Baseline72578291Week 872578289Week 872578291Week 872578290Week 1672578290Week 1672578289Week 1672578291Week 2472578289Week 2472578290Week 2472578291Week 4072578289Week 4072578290Week 4072578291Week 5672578289Week 5672578290Week 5672578291Week 6472578290Week 6472578289Week 6472578291
No problems doing usual activitiesSlight problems doing usual activitiesModerate problems doing usual activitiesSevere problems doing usual activitiesUnable to do usual activities
Tanezumab 2.5 mg22
Tanezumab 5 mg24
NSAID38
Tanezumab 5 mg218
NSAID225
Tanezumab 2.5 mg538
Tanezumab 5 mg551
NSAID561
Tanezumab 2.5 mg208
Tanezumab 5 mg201
NSAID169
Tanezumab 2.5 mg3
Tanezumab 5 mg1
Tanezumab 2.5 mg229
Tanezumab 5 mg266
NSAID221
Tanezumab 5 mg411
NSAID426
Tanezumab 2.5 mg292
Tanezumab 5 mg256
NSAID274
Tanezumab 2.5 mg33
Tanezumab 5 mg31
NSAID35
Tanezumab 2.5 mg0
NSAID0
Tanezumab 2.5 mg302
Tanezumab 5 mg333
NSAID310
Tanezumab 2.5 mg402
Tanezumab 5 mg382
NSAID408
Tanezumab 2.5 mg184
Tanezumab 5 mg182
NSAID172
Tanezumab 2.5 mg24
Tanezumab 5 mg21
NSAID24
Tanezumab 2.5 mg1
Tanezumab 5 mg2
Tanezumab 2.5 mg262
Tanezumab 5 mg290
NSAID273
Tanezumab 2.5 mg353
Tanezumab 5 mg315
NSAID344
Tanezumab 2.5 mg174
NSAID166
Tanezumab 2.5 mg27
Tanezumab 5 mg27
NSAID29
Tanezumab 2.5 mg225
Tanezumab 5 mg221
NSAID218
Tanezumab 2.5 mg239
Tanezumab 5 mg213
NSAID233
Tanezumab 2.5 mg85
Tanezumab 5 mg97
NSAID74
Tanezumab 2.5 mg12
Tanezumab 5 mg20
NSAID10
Tanezumab 2.5 mg155
Tanezumab 5 mg170
NSAID182
Tanezumab 2.5 mg211
Tanezumab 5 mg179
NSAID199
Tanezumab 2.5 mg79
Tanezumab 5 mg86
NSAID69
Tanezumab 2.5 mg13
Tanezumab 5 mg22
NSAID9
Tanezumab 2.5 mg101
Tanezumab 5 mg69
NSAID129
Tanezumab 2.5 mg173
Tanezumab 5 mg163
NSAID197
Tanezumab 2.5 mg138
Tanezumab 5 mg155
NSAID115
Tanezumab 2.5 mg37
Tanezumab 5 mg37
NSAID12
Tanezumab 5 mg4
NSAID1

Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment?

The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. Number of participants who responded for the specified question were reported. (NCT02528188)
Timeframe: Weeks 16 and 56

InterventionParticipants (Count of Participants)
Week 1672578291Week 1672578290Week 1672578289Week 5672578289Week 5672578291Week 5672578290
Yes, definitely prefer the study drugSlight preference for the study drugNo preference either waySlight preference for my previous treatmentNo, definitely prefer my previous treatment
Tanezumab 2.5 mg577
Tanezumab 5 mg597
NSAID531
Tanezumab 2.5 mg141
Tanezumab 5 mg169
NSAID158
Tanezumab 2.5 mg149
Tanezumab 5 mg114
NSAID164
Tanezumab 2.5 mg28
Tanezumab 5 mg34
NSAID36
Tanezumab 2.5 mg44
Tanezumab 5 mg40
NSAID47
Tanezumab 2.5 mg342
Tanezumab 5 mg323
NSAID302
Tanezumab 2.5 mg70
Tanezumab 5 mg75
NSAID89
Tanezumab 2.5 mg61
Tanezumab 5 mg65
NSAID71
Tanezumab 2.5 mg16
Tanezumab 5 mg16
NSAID13
Tanezumab 2.5 mg9
Tanezumab 5 mg8
NSAID14

Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain?

The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess participant willingness to use drug again, participants responded using IRT on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Number of participants who responded for the specified question were reported. (NCT02528188)
Timeframe: Weeks 16 and 56

InterventionParticipants (Count of Participants)
Week 1672578289Week 1672578291Week 1672578290Week 5672578289Week 5672578290Week 5672578291
Yes, definitely want to use the same drug againMight want to use the same drug againI am not sureMight not want to use the same drug againNo:definitely wouldn't want to use same drug again
Tanezumab 2.5 mg627
Tanezumab 5 mg641
NSAID560
Tanezumab 2.5 mg138
Tanezumab 5 mg154
NSAID169
Tanezumab 2.5 mg108
Tanezumab 5 mg96
NSAID134
Tanezumab 2.5 mg19
Tanezumab 5 mg21
NSAID23
Tanezumab 2.5 mg47
Tanezumab 5 mg42
NSAID50
Tanezumab 2.5 mg352
Tanezumab 5 mg341
NSAID310
Tanezumab 2.5 mg78
Tanezumab 5 mg75
NSAID97
Tanezumab 2.5 mg54
Tanezumab 5 mg46
NSAID58
Tanezumab 2.5 mg4
Tanezumab 5 mg11
Tanezumab 2.5 mg10
Tanezumab 5 mg14
NSAID12

Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling?

The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Number of participants who responded for the specified question were reported. (NCT02528188)
Timeframe: Weeks 16 and 56

InterventionParticipants (Count of Participants)
Week 1672578289Week 1672578291Week 1672578290Week 5672578289Week 5672578290Week 5672578291
SurgeryPrescription medicines and surgeryInjectable prescription medicinesPrescription medicines taken by mouthNo treatment
Tanezumab 2.5 mg99
Tanezumab 5 mg98
NSAID82
Tanezumab 2.5 mg611
Tanezumab 5 mg633
NSAID647
Tanezumab 2.5 mg7
Tanezumab 5 mg7
NSAID9
Tanezumab 2.5 mg33
Tanezumab 5 mg28
NSAID27
Tanezumab 2.5 mg189
Tanezumab 5 mg188
NSAID171
Tanezumab 2.5 mg44
Tanezumab 5 mg47
NSAID40
Tanezumab 2.5 mg307
Tanezumab 5 mg296
NSAID324
Tanezumab 2.5 mg8
Tanezumab 5 mg4
NSAID2
Tanezumab 2.5 mg20
Tanezumab 5 mg18
NSAID20
Tanezumab 2.5 mg119
Tanezumab 5 mg122
NSAID103

Number of Participants Who Discontinued Due to Lack of Efficacy

Number of participants who discontinued due to lack of efficacy were reported. (NCT00864097)
Timeframe: Baseline up to end of study (Week 32)

InterventionParticipants (Count of Participants)
Placebo + Diclofenac9
Tanezumab 2.5 mg + Diclofenac3
Tanezumab 5 mg + Diclofenac7
Tanezumab 10 mg + Diclofenac2

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24

SF-36v2 was a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and role limitations due to emotional problems, bodily pain, general health, vitality, and mental health. The total score and the score for a section was an average of the individual question scores, which were scaled 0-100. Higher scores reflected better participant status and positive change indicated an improvement. (NCT00864097)
Timeframe: Baseline, Week 12, and 24

,,,
Interventionunits on a scale (Mean)
Baseline: General HealthBaseline: Physical FunctionBaseline: Role PhysicalBaseline: Bodily PainBaseline: VitalityBaseline: Social FunctionBaseline: Role EmotionalBaseline: Mental HealthChange at Week 12: General HealthChange at Week 12: Physical FunctionChange at Week 12: Role PhysicalChange at Week 12: Bodily PainChange at Week 12: VitalityChange at Week 12: Social FunctionChange at Week 12: Role EmotionalChange at Week 12: Mental HealthChange at Week 24: General HealthChange at Week 24: Physical FunctionChange at Week 24: Role PhysicalChange at Week 24: Bodily PainChange at Week 24: VitalityChange at Week 24: Social FunctionChange at Week 24: Role EmotionalChange at Week 24: Mental Health
Placebo + Diclofenac46.3733.5146.6732.9949.0861.0268.1562.804.677.367.618.763.805.021.923.132.416.215.179.141.664.36-0.551.27
Tanezumab 10 mg + Diclofenac49.3136.5247.4635.0651.2966.5569.7765.484.969.908.4912.765.344.22-1.261.663.088.505.9111.522.761.38-1.950.45
Tanezumab 2.5 mg + Diclofenac49.4136.2247.4435.6652.2267.6368.9666.575.2910.968.8112.514.236.252.241.554.518.788.4112.542.434.090.692.06
Tanezumab 5 mg + Diclofenac47.0034.7048.5033.9553.0065.8368.4464.636.5512.837.7115.183.794.172.172.204.9410.506.9613.272.583.67-1.331.63

Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24

SF-36v2: standardized survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100. Higher scores reflect better participant status and positive change indicated an improvement. For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. (NCT00864097)
Timeframe: Baseline, Week 12 and 24

,,,
Interventionz-score (Mean)
Baseline: Physical Component ScoreBaseline: Mental Component ScoreChange at Week 12: Physical Component ScoreChange at Week 12: Mental Component ScoreChange at Week 24: Physical Component ScoreChange at Week 24: Mental Component Score
Placebo + Diclofenac-1.84-0.300.350.080.32-0.03
Tanezumab 10 mg + Diclofenac-1.76-0.150.51-0.060.43-0.14
Tanezumab 2.5 mg + Diclofenac-1.76-0.110.500.010.45-0.03
Tanezumab 5 mg + Diclofenac-1.80-0.170.56-0.030.50-0.10

Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24

Participants were asked to assess index joint (knee/hip) pain during the past 24 hours on an 0-10 point integer scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline score was calculated as the mean of the scores in the index joint over the 3 days days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores in the index joint within each study week. The change from Baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score, where negative change indicated an improvement. (NCT00864097)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 10Change at Week 12Change at Week 16Change at Week 20Change at Week 24
Placebo + Diclofenac6.31-0.55-0.95-1.19-1.28-1.38-1.41-1.41-1.49-1.53-1.61-1.65
Tanezumab 10 mg + Diclofenac6.34-0.96-1.03-1.08-1.44-1.69-1.80-2.06-2.06-2.15-2.15-2.03
Tanezumab 2.5 mg + Diclofenac6.29-0.74-0.91-1.19-1.45-1.57-1.62-1.79-1.91-1.87-1.95-1.84
Tanezumab 5 mg + Diclofenac6.38-1.22-1.28-1.40-1.77-1.88-1.84-2.09-2.06-2.07-2.19-2.07

Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24

EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health). Negative change from baseline represented worsening. (NCT00864097)
Timeframe: Baseline, Week 24

,,,
Interventionunits on a scale (Mean)
Baseline: Index ScoreChange at Week 24: Index Score
Placebo + Diclofenac0.450.11
Tanezumab 10 mg + Diclofenac0.470.16
Tanezumab 2.5 mg + Diclofenac0.480.15
Tanezumab 5 mg + Diclofenac0.470.14

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16

"Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition." (NCT00864097)
Timeframe: Baseline, Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Placebo + Diclofenac3.39-0.41
Tanezumab 10 mg + Diclofenac3.37-0.63
Tanezumab 2.5 mg + Diclofenac3.28-0.49
Tanezumab 5 mg + Diclofenac3.43-0.61

Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24

"Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition." (NCT00864097)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24
Placebo + Diclofenac-0.36-0.40-0.37-0.45-0.45
Tanezumab 10 mg + Diclofenac-0.28-0.54-0.66-0.61-0.57
Tanezumab 2.5 mg + Diclofenac-0.37-0.45-0.44-0.52-0.46
Tanezumab 5 mg + Diclofenac-0.40-0.65-0.71-0.69-0.57

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. (NCT00864097)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24
Placebo + Diclofenac-1.30-1.51-1.63-1.81-1.81
Tanezumab 10 mg + Diclofenac-0.86-1.93-2.34-2.42-2.19
Tanezumab 2.5 mg + Diclofenac-1.22-1.76-1.88-2.23-2.11
Tanezumab 5 mg + Diclofenac-1.21-2.12-2.22-2.50-2.24

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00864097)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 24
Placebo + Diclofenac-1.31-1.46-1.59-1.75-1.70
Tanezumab 10 mg + Diclofenac-1.06-1.81-2.13-2.28-2.08
Tanezumab 2.5 mg + Diclofenac-1.18-1.58-1.76-2.13-1.99
Tanezumab 5 mg + Diclofenac-1.30-2.09-2.22-2.43-2.17

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24

WOMAC Index: self-administered, disease-specific 24 item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items), and physical function (17 items) in participants with osteoarthritis of the hip and/or knee. WOMAC average score is the mean of the WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, with higher score indicating worse response. Greater reduction in WOMAC average score indicated greater improvement. (NCT00864097)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 24
Placebo + Diclofenac6.05-1.31-1.45-1.59-1.74-1.80-1.74
Tanezumab 10 mg + Diclofenac5.80-1.06-1.92-2.27-2.42-2.43-2.17
Tanezumab 2.5 mg + Diclofenac5.75-1.23-1.68-1.83-2.24-2.19-2.05
Tanezumab 5 mg + Diclofenac5.72-1.30-2.14-2.21-2.45-2.22-2.16

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Weeks 2, 4, 8, 12, 16, and 24

"Participants answered the question: How much pain have you had when going up or down the stairs? Participants responded by using an 11-point scale, where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement." (NCT00864097)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 24
Placebo + Diclofenac7.24-1.38-1.58-1.78-2.03-2.00-1.95
Tanezumab 10 mg + Diclofenac7.06-1.21-2.10-2.64-2.77-2.79-2.56
Tanezumab 2.5 mg + Diclofenac7.04-1.49-2.10-2.15-2.54-2.54-2.44
Tanezumab 5 mg + Diclofenac7.05-1.55-2.39-2.51-2.86-2.53-2.53

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, and 24

"Participants answered the question: How much pain have you had when walking on a flat surface? Participants responded by using an 11-point scale where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement." (NCT00864097)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 24
Placebo + Diclofenac6.12-1.34-1.47-1.62-1.83-1.95-1.84
Tanezumab 10 mg + Diclofenac5.99-0.89-1.87-2.25-2.41-2.34-2.10
Tanezumab 2.5 mg + Diclofenac5.91-1.23-1.75-1.81-2.15-2.14-2.08
Tanezumab 5 mg + Diclofenac5.81-1.07-2.01-2.05-2.35-2.09-2.09

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. (NCT00864097)
Timeframe: Baseline, Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Placebo + Diclofenac6.06-1.91
Tanezumab 10 mg + Diclofenac5.87-2.42
Tanezumab 2.5 mg + Diclofenac5.78-2.18
Tanezumab 5 mg + Diclofenac5.76-2.28

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00864097)
Timeframe: Baseline, Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Placebo + Diclofenac6.24-1.76
Tanezumab 10 mg + Diclofenac5.91-2.35
Tanezumab 2.5 mg + Diclofenac5.86-2.11
Tanezumab 5 mg + Diclofenac5.90-2.23

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, and 24

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee/hip. Negative change indicated an improvement. (NCT00864097)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 24
Placebo + Diclofenac5.84-1.31-1.37-1.56-1.66-1.72-1.70
Tanezumab 10 mg + Diclofenac5.60-1.27-2.01-2.34-2.55-2.53-2.22
Tanezumab 2.5 mg + Diclofenac5.61-1.29-1.71-1.86-2.36-2.27-2.06
Tanezumab 5 mg + Diclofenac5.51-1.38-2.21-2.20-2.42-2.15-2.08

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. (NCT00864097)
Timeframe: Baseline up to 112 days after last intravenous dose (up to Week 32)

,,,
InterventionParticipants (Count of Participants)
AEsSAEs
Placebo + Diclofenac538
Tanezumab 10 mg + Diclofenac7210
Tanezumab 2.5 mg + Diclofenac7112
Tanezumab 5 mg + Diclofenac738

Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24

"EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). Baseline EQ-5D individual health state profile was determined as number of participants no dysfunction, moderate or some dysfunction and extreme dysfunction and change from baseline in EQ-5D individual health state profile was determined as number of participants improved, no change or worsened." (NCT00864097)
Timeframe: Baseline, Week 24

,,,
InterventionParticipants (Count of Participants)
Baseline: Mobility-No DysfunctionBaseline: Mobility-Moderate DysfunctionBaseline: Mobility-Extreme DysfunctionBaseline: Self Care-No DysfunctionBaseline: Self Care-Moderate DysfunctionBaseline: Self Care-Extreme DysfunctionBaseline: Usual Activities-No DysfunctionBaseline: Usual Activities-Moderate DysfunctionBaseline: Usual Activities-Extreme DysfunctionBaseline: Pain/Discomfort-No DysfunctionBaseline: Pain/Discomfort-Moderate DysfunctionBaseline: Pain/Discomfort-Extreme DysfunctionBaseline: Anxiety/Depression-No DysfunctionBaseline: Anxiety/Depression-Moderate DysfunctionBaseline: Anxiety/Depression-Extreme DysfunctionChange at Week 24: Mobility-ImprovedChange at Week 24: Mobility-No ChangeChange at Week 24: Mobility-WorsenedChange at Week 24: Self Care-ImprovedChange at Week 24: Self Care-No ChangeChange at Week 24: Self Care-WorsenedChange at Week 24: Usual Activities-ImprovedChange at Week 24: Usual Activities-No ChangeChange at Week 24: Usual Activities-WorsenedChange at Week 24: Pain/Discomfort-ImprovedChange at Week 24: Pain/Discomfort-No ChangeChange at Week 24: Pain/Discomfort-WorsenedChange at Week 24: Anxiety/Depression-ImprovedChange at Week 24: Anxiety/Depression-No ChangeChange at Week 24: Anxiety/Depression-Worsened
Placebo + Diclofenac8143165870251161101143874726211274191181516125112811682710619
Tanezumab 10 mg + Diclofenac101350529211812341111337366625120030104112711173310571910719
Tanezumab 2.5 mg + Diclofenac71481619231314120125318272225129233112112712542912522611119
Tanezumab 5 mg + Diclofenac141360539612012642115337075530114632110831106133410972810913

Number of Participants With Intravenous Doses of Study Medication

Number of participants were reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received. (NCT00864097)
Timeframe: Day 1 up to Week 16

,,,
InterventionParticipants (Count of Participants)
Number of IV Doses: 1Number of IV Doses: 2Number of IV Doses: 3
Placebo + Diclofenac1438100
Tanezumab 10 mg + Diclofenac1331101
Tanezumab 2.5 mg + Diclofenac934114
Tanezumab 5 mg + Diclofenac1526109

Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score; LOCF

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with reduction in WOMAC pain intensity of at least (>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16, 24 and 32 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. (NCT00864097)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionpercentage of participants (Number)
Week 2: At least 30% reductionWeek 2: At least 50% reductionWeek 2: At least 70% reductionWeek 2: At least 90% reductionWeek 4: At least 30% reductionWeek 4: At least 50% reductionWeek 4: At least 70% reductionWeek 4: At least 90% reductionWeek 8: At least 30% reductionWeek 8: At least 50% reductionWeek 8: At least 70% reductionWeek 8: At least 90% reductionWeek 12: At least 30% reductionWeek 12: At least 50% reductionWeek 12: At least 70% reductionWeek 12: At least 90% reductionWeek 16: At least 30% reductionWeek 16: At least 50% reductionWeek 16: At least 70% reductionWeek 16: At least 90% reductionWeek 24: At least 30% reductionWeek 24: At least 50% reductionWeek 24: At least 70% reductionWeek 24: At least 90% reduction
Placebo + Diclofenac30.313.84.62.042.117.15.92.043.425.03.92.048.727.07.22.050.030.913.22.048.028.312.53.9
Tanezumab 10 mg + Diclofenac24.19.02.80.750.330.311.72.163.438.619.36.263.442.824.84.866.249.019.36.959.342.121.48.3
Tanezumab 2.5 mg + Diclofenac28.816.06.41.351.926.910.31.951.927.69.65.157.136.516.76.454.535.917.35.858.338.518.68.3
Tanezumab 5 mg + Diclofenac32.016.77.31.357.334.012.76.057.338.017.34.764.046.724.08.761.340.020.06.759.340.022.78.0

Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16 and 24 were reported. (NCT00864097)
Timeframe: Baseline, Week 16 and 24

,,,
Interventionpercentage of participants (Number)
Week 16: Greater than 0% reductionWeek 16: >=10% reductionWeek 16: >=20% reductionWeek 16: >=30% reductionWeek 16: >=40% reductionWeek 16: >=50% reductionWeek 16: >=60% reductionWeek 16: >=70% reductionWeek 16: >=80% reductionWeek 16: >=90% reductionWeek 16: 100% reductionWeek 24: Greater than 0% reductionWeek 24: >=10% reductionWeek 24: >=20% reductionWeek 24: >=30% reductionWeek 24: >=40% reductionWeek 24: >=50% reductionWeek 24: >=60% reductionWeek 24: >=70% reductionWeek 24: >=80% reductionWeek 24: >=90% reductionWeek 24: 100% reduction
Placebo + Diclofenac84.273.761.850.038.830.921.713.25.92.00.781.672.460.548.035.528.320.412.56.63.90.7
Tanezumab 10 mg + Diclofenac84.177.975.266.260.749.031.719.313.86.92.884.875.269.759.351.042.131.721.413.88.32.8
Tanezumab 2.5 mg + Diclofenac88.582.769.954.548.735.926.317.39.05.82.682.776.967.358.347.438.526.318.611.58.33.8
Tanezumab 5 mg + Diclofenac88.776.768.761.350.740.028.720.010.76.72.082.074.765.359.347.340.034.022.714.78.03.3

Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF)

"Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicates improvement." (NCT00864097)
Timeframe: Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 24
Placebo + Diclofenac5.96.65.36.64.65.3
Tanezumab 10 mg + Diclofenac5.511.713.810.314.59.7
Tanezumab 2.5 mg + Diclofenac5.83.26.46.45.84.5
Tanezumab 5 mg + Diclofenac4.714.717.313.314.010.0

Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF

"Participants answered: Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today? Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicated improvement." (NCT00864097)
Timeframe: Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 24
Placebo + Diclofenac5.96.65.36.64.65.9
Tanezumab 10 mg + Diclofenac5.512.414.512.416.612.4
Tanezumab 2.5 mg + Diclofenac5.83.26.46.45.85.8
Tanezumab 5 mg + Diclofenac4.714.718.014.014.712.7

Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF

OMERACT-OARSI responder: participant has >=50 percent (%) change and >=2 absolute change from Baseline in either WOMAC pain or physical function subscale scores or at least 2 of the following being true: >=20% change and >=1 absolute change from Baseline in WOMAC pain subscale; >=20% change and >=1 absolute change from Baseline in the WOMAC physical function subscale; >=20% change and >=1 absolute change from Baseline in PGA of osteoarthritis. WOMAC pain and physical function score: 0 to 10 with higher score = worse response. PGA score: 1 = very good and 5 = very poor. (NCT00864097)
Timeframe: Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16Week 24
Placebo + Diclofenac44.751.357.260.557.955.3
Tanezumab 10 mg + Diclofenac34.559.369.773.172.467.6
Tanezumab 2.5 mg + Diclofenac37.257.158.367.366.765.4
Tanezumab 5 mg + Diclofenac43.365.368.073.366.764.7

Time to Discontinuation (TTD) Due to Lack of Efficacy

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. (NCT00864097)
Timeframe: Baseline up to Week 16 and 24

,,,
Interventiondays (Median)
Week 16Week 24
Placebo + DiclofenacNANA
Tanezumab 10 mg + DiclofenacNANA
Tanezumab 2.5 mg + DiclofenacNANA
Tanezumab 5 mg + DiclofenacNANA

Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline." (NCT01461369)
Timeframe: Baseline to Week 12/Early Termination

Interventionmm (Least Squares Mean)
Diclofenac 35 mg Two Times Daily-35.62
Diclofenac 35 mg Three Times Daily-41.38
Placebo-28.14

Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.

"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline." (NCT01461369)
Timeframe: Baseline to Week 12/Early Termination

Interventionmm (Least Squares Mean)
Diclofenac 35 mg Two Times Daily-30.25
Diclofenac 35 mg Three Times Daily-35.86
Placebo-23.22

Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.

"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Pain Imaginable.~The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline." (NCT01461369)
Timeframe: Baseline to Week 12/Early Termination

Interventionmm (Least Squares Mean)
Diclofenac 35 mg Two Times Daily-36.41
Diclofenac 35 mg Three Times Daily-41.33
Placebo-30.95

Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline." (NCT01461369)
Timeframe: Baseline to Week 12/Early Termination

Interventionmm (Least Squares Mean)
Diclofenac 35 mg Two Times Daily-39.04
Diclofenac 35 mg Three Times Daily-44.14
Placebo-32.46

Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline." (NCT01461369)
Timeframe: Baseline to Week 2

Interventionmm (Least Squares Mean)
Diclofenac 35 mg Two Times Daily-31.40
Diclofenac 35 mg Three Times Daily-37.42
Placebo-21.60

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline." (NCT01461369)
Timeframe: Baseline to Week 6

Interventionmm (Least Squares Mean)
Diclofenac 35 mg Two Times Daily-36.64
Diclofenac 35 mg Three Times Daily-43.51
Placebo-31.08

Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET

The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. (NCT01510912)
Timeframe: Baseline to Week 52/Early Termination

Interventionunits on a scale (Mean)
Mean score at Week 52/early termination (ET)Change from baseline to Week 52/ET
Diclofenac 35 mg Capsules52.30.1

Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET

The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. (NCT01510912)
Timeframe: Baseline to Week 52/Early Termination

Interventionunits on a scale (Mean)
Mean score at Week 52/early termination (ET)Mean change from baseline to Week 52/ET
Diclofenac 35 mg Capsules44.24.5

Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination

The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events. (NCT01510912)
Timeframe: Baseline to Week 52/Early Termination

Interventionparticipants (Number)
Subjects with at least 1 TEAESubjects with at least 1 severe TEAESubjects with at least 1 serious adverse event
Diclofenac 35 mg Capsules4514142

Reviews

1 review available for diclofenac and Coxarthrosis

ArticleYear
Celecoxib for osteoarthritis.
    The Cochrane database of systematic reviews, 2017, 05-22, Volume: 5

    Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Diclofenac; Female; Humans; Male; Middle

2017

Trials

25 trials available for diclofenac and Coxarthrosis

ArticleYear
Diclofenac-hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial.
    BMC musculoskeletal disorders, 2022, Apr-20, Volume: 23, Issue:1

    Topics: Ankle; Diclofenac; Double-Blind Method; Elbow; Humans; Hyaluronic Acid; Injections, Intra-Articular;

2022
Long-Term Safety and Efficacy of Subcutaneous Tanezumab Versus Nonsteroidal Antiinflammatory Drugs for Hip or Knee Osteoarthritis: A Randomized Trial.
    Arthritis & rheumatology (Hoboken, N.J.), 2021, Volume: 73, Issue:7

    Topics: Adult; Aged; Aged, 80 and over; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Blo

2021
[Evidence of feasibility etoricoxib therapy in osteoarthritis in elderly patients].
    Advances in gerontology = Uspekhi gerontologii, 2016, Volume: 29, Issue:2

    Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Arthralgia; Diclofenac; Drug Monit

2016
Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial.
    Annals of the rheumatic diseases, 2014, Volume: 73, Issue:9

    Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal, Hum

2014
Efficacy and safety of low-dose submicron diclofenac for the treatment of osteoarthritis pain: a 12 week, phase 3 study.
    Current medical research and opinion, 2014, Volume: 30, Issue:9

    Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Chemistry, Pharmaceutical;

2014
Low-dose SoluMatrix diclofenac in the treatment of osteoarthritis: A 1-year, open-label, Phase III safety study.
    Postgraduate medicine, 2015, Volume: 127, Issue:5

    Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Drug Administra

2015
Low-dose SoluMatrix diclofenac in patients with osteoarthritis pain: impact on quality of life in a controlled trial.
    Clinical rheumatology, 2017, Volume: 36, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Female; Humans;

2017
[Comparative observation on hip osteoarthritis treated with electroacupuncture and medication].
    Zhongguo zhen jiu = Chinese acupuncture & moxibustion, 2010, Volume: 30, Issue:12

    Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Electroacupunct

2010
A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis.
    Clinical rheumatology, 2011, Volume: 30, Issue:11

    Topics: Adult; Aged; Aged, 80 and over; Cyclooxygenase 2 Inhibitors; Diclofenac; Double-Blind Method; Female

2011
Influence of a specific ginger combination on gastropathy conditions in patients with osteoarthritis of the knee or hip.
    Journal of alternative and complementary medicine (New York, N.Y.), 2012, Volume: 18, Issue:6

    Topics: Abdominal Pain; Alprostadil; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Dinoprost; Dinopro

2012
A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis.
    Current medical research and opinion, 2003, Volume: 19, Issue:8

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac; Double-

2003
Continuous local cooling for pain relief following total hip arthroplasty.
    The Journal of arthroplasty, 2004, Volume: 19, Issue:3

    Topics: Analgesics; Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Arthroplasty, Replacement,

2004
Efficacy and safety of four doses of lumiracoxib versus diclofenac in patients with knee or hip primary osteoarthritis: a phase II, four-week, multicenter, randomized, double-blind, placebo-controlled trial.
    Arthritis and rheumatism, 2004, Aug-15, Volume: 51, Issue:4

    Topics: Aged; Cyclooxygenase Inhibitors; Diclofenac; Double-Blind Method; Female; Health Status; Humans; Mal

2004
Patient preference in a crossover clinical trial of patients with osteoarthritis of the knee or hip: face validity of self-report questionnaire ratings.
    The Journal of rheumatology, 2005, Volume: 32, Issue:3

    Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Cross-Over Studies

2005
Analgesic effectiveness of celecoxib and diclofenac in patients with osteoarthritis of the hip requiring joint replacement surgery: a 12-week, multicenter, randomized, double-blind, parallel-group, double-dummy, noninferiority study.
    Clinical therapeutics, 2008, Volume: 30, Issue:1

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthroplasty, Replacement, Hip; Celecoxib; Diclofenac

2008
[Oxaprozin versus diclofenac retard in treated of activated arthrosis].
    Zeitschrift fur Rheumatologie, 1998, Volume: 57, Issue:2

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Delayed-Action Preparations; Diclofenac; Dose-

1998
Diclofenac/misoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip: a randomized, placebo controlled trial. Arthrotec Osteoarthritis Study Group.
    The Journal of rheumatology, 1998, Volume: 25, Issue:8

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Drug Therapy,

1998
Oxaceprol is as effective as diclofenac in the therapy of osteoarthritis of the knee and hip.
    Clinical rheumatology, 1999, Volume: 18, Issue:1

    Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Arthr

1999
Nabumetone induces less gastrointestinal mucosal changes than diclofenac retard.
    Clinical rheumatology, 1999, Volume: 18, Issue:4

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Butanones; Dicl

1999
Comparison of therapeutic efficacy of nimesulide and diclofenac in patients with degenerative joint diseases.
    Journal of the Indian Medical Association, 1999, Volume: 97, Issue:4

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Dou

1999
Oxaceprol is a well-tolerated therapy for osteoarthritis with efficacy equivalent to diclofenac.
    Clinical rheumatology, 2000, Volume: 19, Issue:2

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthralgia; Diclofenac; Double-Blind Method; Female; Humans

2000
Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip. Rofecoxib Phase III Protocol 035
    Arthritis and rheumatism, 2000, Volume: 43, Issue:5

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac; Double-

2000
A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee.
    Arthritis and rheumatism, 2001, Volume: 44, Issue:7

    Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents;

2001
Double-blind, randomized and parallel comparison between droxicam and diclofenac sodium in patients with coxarthrosis and gonarthrosis.
    European journal of rheumatology and inflammation, 1991, Volume: 11, Issue:4

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Female; Human

1991
Double-blind randomized controlled trial of flurbiprofen-SR (ANSAID-SR) and diclofenac sodium-SR (Voltaren-SR) in the treatment of osteoarthritis.
    Clinical and investigative medicine. Medecine clinique et experimentale, 1992, Volume: 15, Issue:5

    Topics: Adolescent; Adult; Aged; Diclofenac; Double-Blind Method; Flurbiprofen; Humans; Middle Aged; Osteoar

1992

Other Studies

13 other studies available for diclofenac and Coxarthrosis

ArticleYear
[Paracetamol in knee and hip arthrosis is dispensable].
    MMW Fortschritte der Medizin, 2016, Apr-14, Volume: 158, Issue:7

    Topics: Acetaminophen; Diclofenac; Etoricoxib; Humans; Naproxen; Osteoarthritis, Hip; Osteoarthritis, Knee;

2016
[Effect of protracted therapy with chondroprotectors and non-steroidal anti-inflammatory drugs on the quality of life in patients with osteoarthrosis].
    Klinicheskaia meditsina, 2009, Volume: 87, Issue:4

    Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Chondroitin Sulfates; Diclofenac; Female; Huma

2009
Safe administration of celecoxib to a patient with repeated episodes of nephrotic syndrome induced by NSAIDs.
    Clinical drug investigation, 2011, Volume: 31, Issue:5

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Cyclooxygenase 2 Inhibitors; Diclofenac; Humans;

2011
Is there an association between the use of different types of nonsteroidal antiinflammatory drugs and radiologic progression of osteoarthritis? The Rotterdam Study.
    Arthritis and rheumatism, 2005, Volume: 52, Issue:10

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Disease Progression; Female; Follow-Up St

2005
Does diclofenac induce accelerated progression of hip and knee radiographic osteoarthritis? Comment on the article by Reijman et al.
    Arthritis and rheumatism, 2006, Volume: 54, Issue:3

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Disease Progression; Humans; Osteoarthritis, Hi

2006
Testing drugs on human osteoarthritic articular cartilage.
    Cell biochemistry and function, 1994, Volume: 12, Issue:1

    Topics: Aged; Aged, 80 and over; Alcian Blue; Birefringence; Cartilage, Articular; Diclofenac; Female; Hip J

1994
[Diclofenac/orphenadrine infusion therapy in patients with active arthrosis].
    Wiener medizinische Wochenschrift (1946), 1998, Volume: 148, Issue:7

    Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Drug Administration Schedule; Drug Combin

1998
Tissue concentration of the active substance of Voltaren SR 75 in articular cartilage, synovial membrane and bone.
    Clinical rheumatology, 2000, Volume: 19, Issue:2

    Topics: Anti-Inflammatory Agents, Non-Steroidal; Bone and Bones; Cartilage, Articular; Chromatography, High

2000
Non-steroidal hip arthropathy: case histories and differential diagnosis.
    Hospital medicine (London, England : 1998), 2001, Volume: 62, Issue:5

    Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Diagnosis, Differential; Diclofena

2001
Are NSAIDs more effective than acetaminophen in patients with osteoarthritis?
    The Journal of family practice, 2001, Volume: 50, Issue:10

    Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents;

2001
[Impact of the education of a patient with arthrosis].
    La Revue du praticien, 2002, Mar-01, Volume: 52, Issue:5 Suppl

    Topics: Aged; Aged, 80 and over; Cyclooxygenase Inhibitors; Diclofenac; Drug Therapy, Combination; Exercise

2002
In vitro effect of nonsteroidal antiinflammatory drugs on proteoglycanase and collagenase activity in human osteoarthritic cartilage.
    Arthritis and rheumatism, 1991, Volume: 34, Issue:10

    Topics: Acetaminophen; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cartilage, Articular; Diclofenac; Endo

1991
NSAIDs and avascular necrosis.
    Orthopaedic review, 1988, Volume: 17, Issue:11

    Topics: Aged; Aged, 80 and over; Diagnostic Errors; Diclofenac; Female; Femur Head Necrosis; Humans; Osteoar

1988