Page last updated: 2024-10-24

celecoxib and Hypesthesia

celecoxib has been researched along with Hypesthesia in 1 studies

Hypesthesia: Absent or reduced sensitivity to cutaneous stimulation.

Research Excerpts

Excerpt	Relevance	Reference
" Safety assessments included adverse events, physical and neurological examinations, laboratory tests and vital signs."	2.80	Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. ( Brown, MT; Ekman, EF; Greenberg, HS; Schnitzer, TJ; Smith, MD; Spierings, EL; Verburg, KM; West, CR, 2015)

Research

Studies (1)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Schnitzer, TJ	1
Ekman, EF	1
Spierings, EL	1
Greenberg, HS	1
Smith, MD	1
Brown, MT	1
West, CR	1
Verburg, KM	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS[NCT00809354]			Phase 3	2,720 participants (Actual)	Interventional	2009-02-12	Terminated (stopped due to See termination reason in detailed description.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24

Intervention	change in percent impairment (Mean)
Tanezumab 5 mg (Naproxen Exposure)	-11.90
Tanezumab 10 mg (Naproxen Exposure)	-11.68
Tanezumab 5 mg + Naproxen 500 mg	-5.51
Tanezumab 10 mg + Naproxen 500 mg	-13.00
Naproxen 500 mg	-7.35
Tanezumab 5 mg (Celecoxib Exposure)	-17.81
Tanezumab 10 mg (Celecoxib Exposure)	-13.01
Tanezumab 5 mg + Celecoxib 100 mg	-9.33
Tanezumab 10 mg + Celecoxib 100 mg	-9.63
Celecoxib 100 mg	-5.81

Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24

Intervention	change in percent work time missed (Mean)
Tanezumab 5 mg (Naproxen Exposure)	-0.88
Tanezumab 10 mg (Naproxen Exposure)	0.04
Tanezumab 5 mg + Naproxen 500 mg	0.63
Tanezumab 10 mg + Naproxen 500 mg	-0.77
Naproxen 500 mg	1.11
Tanezumab 5 mg (Celecoxib Exposure)	-2.85
Tanezumab 10 mg (Celecoxib Exposure)	-0.42
Tanezumab 5 mg + Celecoxib 100 mg	1.51
Tanezumab 10 mg + Celecoxib 100 mg	-1.64
Celecoxib 100 mg	-0.61

Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24

Intervention	change in percent activity impairment (Mean)
Tanezumab 5 mg (Naproxen Exposure)	-12.30
Tanezumab 10 mg (Naproxen Exposure)	-15.51
Tanezumab 5 mg + Naproxen 500 mg	-13.55
Tanezumab 10 mg + Naproxen 500 mg	-14.96
Naproxen 500 mg	-10.00
Tanezumab 5 mg (Celecoxib Exposure)	-17.24
Tanezumab 10 mg (Celecoxib Exposure)	-17.84
Tanezumab 5 mg + Celecoxib 100 mg	-18.04
Tanezumab 10 mg + Celecoxib 100 mg	-17.31
Celecoxib 100 mg	-11.90

Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24

Intervention	change in percent work impairment (Mean)
Tanezumab 5 mg (Naproxen Exposure)	-5.40
Tanezumab 10 mg (Naproxen Exposure)	-1.46
Tanezumab 5 mg + Naproxen 500 mg	-0.75
Tanezumab 10 mg + Naproxen 500 mg	-1.35
Naproxen 500 mg	2.09
Tanezumab 5 mg (Celecoxib Exposure)	-10.17
Tanezumab 10 mg (Celecoxib Exposure)	-0.22
Tanezumab 5 mg + Celecoxib 100 mg	1.25
Tanezumab 10 mg + Celecoxib 100 mg	-4.30
Celecoxib 100 mg	-2.29

Number of Participants Who Had Discontinued Study Due to Lack of Efficacy

(NCT00809354)
Timeframe: Baseline up to Week 56

Intervention	Participants (Count of Participants)
Tanezumab 5 mg (Naproxen Exposure)	23
Tanezumab 10 mg (Naproxen Exposure)	23
Tanezumab 5 mg + Naproxen 500 mg	22
Tanezumab 10 mg + Naproxen 500 mg	15
Naproxen 500 mg	40
Tanezumab 5 mg (Celecoxib Exposure)	19
Tanezumab 10 mg (Celecoxib Exposure)	21
Tanezumab 5 mg + Celecoxib 100 mg	15
Tanezumab 10 mg + Celecoxib 100 mg	18
Celecoxib 100 mg	38

Number of Participants With Positive Urine or Serum Pregnancy Test

Female participants, who reported positive in urine or serum pregnancy test were reported. (NCT00809354)
Timeframe: Baseline up to Week 56

Intervention	Participants (Count of Participants)
Tanezumab 5 mg (Naproxen Exposure)	0
Tanezumab 10 mg (Naproxen Exposure)	1
Tanezumab 5 mg + Naproxen 500 mg	0
Tanezumab 10 mg + Naproxen 500 mg	0
Naproxen 500 mg	0
Tanezumab 5 mg (Celecoxib Exposure)	0
Tanezumab 10 mg (Celecoxib Exposure)	0
Tanezumab 5 mg + Celecoxib 100 mg	0
Tanezumab 10 mg + Celecoxib 100 mg	0
Celecoxib 100 mg	0

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 study drug administration up to the date of discontinuation of participant from study due to lack of efficacy. (NCT00809354)
Timeframe: Baseline up to Week 56

Intervention	days (Mean)
Tanezumab 5 mg (Naproxen Exposure)	319.87
Tanezumab 10 mg (Naproxen Exposure)	331.69
Tanezumab 5 mg + Naproxen 500 mg	394.80
Tanezumab 10 mg + Naproxen 500 mg	271.89
Naproxen 500 mg	306.11
Tanezumab 5 mg (Celecoxib Exposure)	329.79
Tanezumab 10 mg (Celecoxib Exposure)	314.16
Tanezumab 5 mg + Celecoxib 100 mg	334.84
Tanezumab 10 mg + Celecoxib 100 mg	324.25
Celecoxib 100 mg	303.08

Amount of Rescue Medication Used

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized. (NCT00809354)
Timeframe: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56

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Intervention	milligram (mg) (Mean)
	Weeks 1-2	Weeks 3-4	Weeks 5-8	Weeks 9-12	Weeks 13-16	Weeks 17-24	Weeks 25-32	Weeks 33-40	Weeks 41-48	Weeks 49-56
Celecoxib 100 mg	3455.85	3281.23	3182.45	3067.56	3269.78	2816.00	3126.26	3032.17	3101.63	3035.33
Naproxen 500 mg	3543.99	3415.52	2991.01	2919.20	2920.39	2759.90	2792.04	2755.66	2746.29	3106.46
Tanezumab 10 mg (Celecoxib Exposure)	3834.79	3769.17	2969.34	3008.85	2938.95	2725.86	2927.44	2976.37	3033.87	2770.28
Tanezumab 10 mg (Naproxen Exposure)	3365.46	3582.77	2875.55	2955.84	2912.14	2778.55	2824.83	2900.69	2906.70	2910.73
Tanezumab 10 mg + Celecoxib 100 mg	3250.69	3011.67	2223.15	2266.13	2486.23	2370.30	2723.26	2682.35	2618.83	2842.74
Tanezumab 10 mg + Naproxen 500 mg	3524.27	3066.65	2396.99	2415.93	2551.21	2261.93	2289.28	2361.40	2373.66	2545.36
Tanezumab 5 mg (Celecoxib Exposure)	3132.30	3255.16	2571.99	2380.78	2450.55	2261.84	2383.27	2449.87	2521.27	2840.21
Tanezumab 5 mg (Naproxen Exposure)	3144.66	3411.93	2846.58	2863.10	2993.63	2733.43	2823.39	2810.18	2927.31	2979.89
Tanezumab 5 mg + Celecoxib 100 mg	2910.68	2672.18	2140.44	2166.23	2244.74	2235.23	2432.81	2428.51	2408.58	2511.61
Tanezumab 5 mg + Naproxen 500 mg	2739.96	2660.11	2131.45	2291.41	2562.94	2525.71	2548.20	2608.91	2673.48	2938.47

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)

The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status. (NCT00809354)
Timeframe: Baseline, Weeks 12 and 24

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Intervention	units on a scale (Mean)
	General health at baseline	Physical function at baseline	Role physical at baseline	Bodily pain at baseline	Vitality at baseline	Social function at baseline	Role emotional at baseline	Mental health at baseline	Change at Week 12: General health	Change at Week 12: Physical function	Change at Week 12: Role physical	Change at Week 12: Bodily pain	Change at Week 12: Vitality	Change at Week 12: Social function	Change at Week 12: Role emotional	Change at Week 12: Mental health	Change at Week 24: General health	Change at Week 24: Physical function	Change at Week 24: Role physical	Change at Week 24: Bodily pain	Change at Week 24: Vitality	Change at Week 24: Social function	Change at Week 24: Role emotional	Change at Week 24: Mental health
Celecoxib 100 mg	55.69	32.81	43.55	36.96	51.52	64.31	63.39	69.08	4.68	7.48	7.58	8.01	2.43	3.33	4.13	0.67	3.90	8.00	7.70	8.72	2.87	4.07	2.23	0.00
Naproxen 500 mg	57.61	35.46	46.09	35.72	50.78	62.23	68.45	70.34	3.88	5.76	6.70	7.83	3.97	7.41	0.92	1.57	2.90	5.75	7.28	8.87	1.90	6.16	2.92	1.52
Tanezumab 10 mg (Celecoxib Exposure)	56.93	34.79	42.86	35.57	51.52	63.68	64.07	71.08	3.37	9.05	10.04	12.50	4.35	5.36	3.64	0.36	4.25	9.33	10.46	10.22	4.00	6.25	4.95	0.42
Tanezumab 10 mg (Naproxen Exposure)	57.41	32.74	43.88	35.90	51.28	65.97	66.35	70.23	4.66	12.88	12.59	13.08	5.14	5.25	5.50	3.28	2.95	9.50	7.42	9.63	3.93	3.21	0.58	1.48
Tanezumab 10 mg + Celecoxib 100 mg	58.27	35.11	45.60	36.47	53.63	66.90	65.05	71.07	5.66	12.99	13.71	16.83	6.47	8.94	6.82	3.17	4.28	12.00	10.50	13.47	4.15	5.78	3.39	0.87
Tanezumab 10 mg + Naproxen 500 mg	57.92	33.88	44.69	37.67	52.57	64.47	67.92	70.40	5.14	14.38	15.39	16.53	6.12	7.76	4.47	3.04	4.54	12.30	11.54	13.04	4.52	6.14	2.16	2.26
Tanezumab 5 mg (Celecoxib Exposure)	56.20	33.43	42.59	34.14	50.52	63.19	63.02	70.95	5.46	12.70	13.36	16.74	7.41	10.19	8.23	3.00	4.07	10.40	10.24	10.69	5.71	7.63	5.81	1.33
Tanezumab 5 mg (Naproxen Exposure)	56.76	32.82	43.29	36.91	51.58	65.63	66.08	70.42	3.29	11.68	9.73	11.44	5.68	5.90	5.08	2.85	3.08	10.52	9.40	10.73	5.94	4.01	3.35	2.31
Tanezumab 5 mg + Celecoxib 100 mg	56.34	33.41	42.65	34.11	51.45	64.51	62.68	68.25	5.18	13.84	15.51	17.15	6.32	8.14	8.63	3.78	3.46	11.83	10.93	14.02	2.84	7.06	6.47	0.94
Tanezumab 5 mg + Naproxen 500 mg	60.66	34.79	44.58	37.80	53.73	68.13	67.74	72.20	3.66	14.23	13.13	14.41	6.47	5.36	4.91	0.96	3.77	9.83	9.58	10.41	3.77	3.21	2.38	0.95

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)

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Intervention	units on a scale (Mean)
	Change at Week 12: General health	Change at Week 12: Physical function	Change at Week 12: Role physical	Change at Week 12: Bodily pain	Change at Week 12: Vitality	Change at Week 12: Social function	Change at Week 12: Role emotional	Change at Week 12: Mental health	Change at Week 24: General health	Change at Week 24: Physical function	Change at Week 24: Role physical	Change at Week 24: Bodily pain	Change at Week 24: Vitality	Change at Week 24: Social function	Change at Week 24: Role emotional	Change at Week 24: Mental health	Change at Week 40: General health	Change at Week 40: Physical function	Change at Week 40: Role physical	Change at Week 40: Bodily pain	Change at Week 40: Vitality	Social function at Week 40	Change at Week 40: Role emotional	Change at Week 40: Mental health	Change at Week 56: General health	Change at Week 56: Physical function	Change at Week 56: Role physical	Change at Week 56: Bodily pain	Change at Week 56: Vitality	Change at Week 56: Social function	Change at Week 56: Role emotional	Change at Week 56: Mental health
Celecoxib 100 mg	4.68	7.48	7.58	8.01	2.43	3.33	4.13	0.67	4.45	8.41	8.27	9.09	2.40	3.97	2.76	0.20	4.09	7.24	7.58	8.17	2.67	2.65	3.41	0.82	3.99	6.91	7.28	8.69	2.08	2.84	3.51	0.96
Naproxen 500 mg	3.88	35.46	46.09	7.83	3.97	7.41	0.92	1.57	3.77	6.43	7.97	9.19	2.57	7.32	2.59	1.38	3.47	6.23	7.01	7.11	2.32	7.23	1.61	0.49	3.33	5.95	7.19	7.47	2.68	7.23	1.67	0.41
Tanezumab 10 mg (Celecoxib Exposure)	3.37	9.05	10.04	12.50	4.35	5.36	3.64	0.36	4.59	10.00	11.84	12.00	4.87	7.09	5.09	0.30	3.31	8.74	10.53	10.87	4.40	6.20	2.99	0.26	3.41	8.25	10.46	10.32	4.47	6.10	3.25	0.18
Tanezumab 10 mg (Naproxen Exposure)	4.66	32.74	43.88	13.08	5.14	5.25	5.50	3.28	3.18	11.35	9.53	11.63	4.34	3.56	1.56	1.51	2.45	10.23	8.79	10.73	3.30	3.21	1.91	1.41	2.31	9.19	8.01	10.21	3.10	2.95	1.53	1.42
Tanezumab 10 mg + Celecoxib 100 mg	5.66	12.99	13.71	16.83	6.47	8.94	6.82	3.17	4.62	12.91	12.45	14.83	4.50	6.57	4.58	1.06	3.45	11.78	12.13	13.28	4.17	6.23	5.47	1.11	3.75	11.48	12.06	13.36	4.15	6.67	5.07	1.25
Tanezumab 10 mg + Naproxen 500 mg	5.14	33.88	44.69	16.53	6.12	7.76	4.47	3.04	4.66	13.73	13.03	14.73	5.48	7.11	3.10	2.65	3.87	11.96	10.00	12.42	4.45	4.56	0.76	1.76	3.69	11.15	9.01	11.92	3.82	3.99	0.47	1.53
Tanezumab 5 mg (Celecoxib Exposure)	5.46	12.70	13.36	16.74	7.41	10.19	8.23	3.00	4.42	11.23	11.74	12.24	5.95	8.51	6.73	1.37	3.74	9.91	11.32	11.45	5.29	7.43	6.69	1.22	3.75	10.12	11.20	11.52	4.82	7.73	6.10	1.10
Tanezumab 5 mg (Naproxen Exposure)	3.29	32.82	43.29	11.44	5.68	5.90	5.08	2.85	3.95	11.70	11.14	12.95	7.17	5.19	5.22	2.90	3.40	10.00	9.64	11.27	5.92	4.05	4.08	2.16	3.12	9.95	9.13	11.58	5.70	4.53	4.23	2.28
Tanezumab 5 mg + Celecoxib 100 mg	5.18	13.84	15.51	17.15	6.32	8.14	8.63	3.78	3.72	12.92	11.84	15.22	3.09	7.35	6.83	1.39	3.20	12.32	12.38	13.96	3.24	6.03	5.98	1.22	3.10	12.07	11.96	13.53	3.41	6.23	6.11	1.47
Tanezumab 5 mg + Naproxen 500 mg	3.66	34.79	44.58	14.41	6.47	5.36	4.91	0.96	3.93	10.85	10.71	11.75	4.42	2.81	3.63	0.45	2.83	10.49	10.98	10.79	4.42	2.19	2.80	0.25	2.59	10.19	10.49	10.38	4.17	1.65	1.99	-0.11

Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56

(NCT00809354)
Timeframe: Baseline, Week 56

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Intervention	millimeter (mm) (Mean)
	Baseline	Change at Week 56
NSAID	3.022	-0.041
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)	2.850	-0.213
Tanezumab 10 mg + NSAID	2.982	-0.172
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)	2.769	-0.189
Tanezumab 5 mg + NSAID	3.005	-0.162

Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56

(NCT00809354)
Timeframe: Baseline, Week 56

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Intervention	millimeter (Mean)
	Baseline	Change at Week 56
NSAID	2.724	-0.028
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)	2.372	-0.137
Tanezumab 10 mg + NSAID	2.195	-0.136
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)	2.447	-0.075
Tanezumab 5 mg + NSAID	2.346	-0.240

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56

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Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	2.18	-0.34	-0.13	-0.22	-0.28	-0.34	-0.36	-0.34	-0.39	-0.36	-0.41
Naproxen 500 mg	2.31	-0.11	-0.08	-0.12	-0.26	-0.18	-0.31	-0.32	-0.40	-0.43	-0.46
Tanezumab 10 mg (Celecoxib Exposure)	2.09	-0.29	-0.30	-0.35	-0.50	-0.56	-0.38	-0.56	-0.50	-0.52	-0.44
Tanezumab 10 mg (Naproxen Exposure)	2.56	-0.25	-0.46	-0.46	-0.43	-0.48	-0.57	-0.57	-0.55	-0.58	-0.53
Tanezumab 10 mg + Celecoxib 100 mg	2.08	-0.33	-0.40	-0.33	-0.26	-0.30	-0.22	-0.26	-0.33	-0.34	-0.43
Tanezumab 10 mg + Naproxen 500 mg	2.54	-0.16	-0.33	-0.38	-0.65	-0.58	-0.60	-0.53	-0.49	-0.65	-0.58
Tanezumab 5 mg (Celecoxib Exposure)	2.04	-0.11	-0.21	-0.32	-0.53	-0.43	-0.35	-0.44	-0.41	-0.44	-0.41
Tanezumab 5 mg (Naproxen Exposure)	2.64	-0.20	-0.37	-0.49	-0.52	-0.77	-0.73	-0.56	-0.50	-0.43	-0.48
Tanezumab 5 mg + Celecoxib 100 mg	2.24	-0.14	-0.40	-0.53	-0.69	-0.79	-0.90	-0.93	-0.50	-0.87	-0.89
Tanezumab 5 mg + Naproxen 500 mg	1.93	-0.30	-0.20	-0.25	-0.38	-0.35	-0.44	-0.52	-0.32	-0.38	-0.45

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	2.18	-0.34	-0.11	-0.35	-0.44	-0.50	-0.50	-0.63	-0.73	-0.69	-0.54
Naproxen 500 mg	2.31	-0.11	-0.11	-0.12	-0.29	-0.26	-0.43	-0.39	-0.42	-0.48	-0.36
Tanezumab 10 mg (Celecoxib Exposure)	2.09	-0.29	-0.30	-0.36	-0.56	-0.64	-0.46	-0.71	-0.58	-0.65	-0.42
Tanezumab 10 mg (Naproxen Exposure)	2.56	-0.25	-0.42	-0.42	-0.38	-0.41	-0.50	-0.53	-0.47	-0.81	-0.70
Tanezumab 10 mg + Celecoxib 100 mg	2.08	-0.33	-0.39	-0.22	-0.38	-0.48	-0.47	-0.49	-0.71	-0.50	-0.38
Tanezumab 10 mg + Naproxen 500 mg	2.54	-0.16	-0.29	-0.30	-0.62	-0.58	-0.57	-0.47	-0.38	-0.80	-0.10
Tanezumab 5 mg (Celecoxib Exposure)	2.04	-0.11	-0.20	-0.32	-0.52	-0.41	-0.37	-0.50	-0.42	-0.56	-0.53
Tanezumab 5 mg (Naproxen Exposure)	2.64	-0.20	-0.40	-0.47	-0.53	-0.81	-0.78	-0.56	-0.61	-0.55	-0.30
Tanezumab 5 mg + Celecoxib 100 mg	2.24	-0.14	-0.41	-0.55	-0.72	-0.83	-0.99	-1.05	-1.06	-1.07	-1.01
Tanezumab 5 mg + Naproxen 500 mg	1.93	-0.30	-0.18	-0.22	-0.34	-0.38	-0.57	-0.78	-0.63	-0.67	-0.83

Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

,,,,,,,,,

Intervention	change in percent impairment (Mean)
	Change at Week 24	Change at Week 56
Celecoxib 100 mg	-5.81	-5.93
Naproxen 500 mg	-7.35	-5.31
Tanezumab 10 mg (Celecoxib Exposure)	-13.01	-12.88
Tanezumab 10 mg (Naproxen Exposure)	-11.68	-11.88
Tanezumab 10 mg + Celecoxib 100 mg	-9.63	-4.25
Tanezumab 10 mg + Naproxen 500 mg	-13.00	-11.33
Tanezumab 5 mg (Celecoxib Exposure)	-17.81	-16.99
Tanezumab 5 mg (Naproxen Exposure)	-11.90	-10.30
Tanezumab 5 mg + Celecoxib 100 mg	-9.33	-8.09
Tanezumab 5 mg + Naproxen 500 mg	-5.51	-4.08

Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24 and 56

,,,,,,,,,

Intervention	change in percent work time missed (Mean)
	Change at Week 24	Change at Week 56
Celecoxib 100 mg	-0.61	-0.82
Naproxen 500 mg	1.11	2.26
Tanezumab 10 mg (Celecoxib Exposure)	-0.42	-0.46
Tanezumab 10 mg (Naproxen Exposure)	0.04	-0.39
Tanezumab 10 mg + Celecoxib 100 mg	-1.64	-1.64
Tanezumab 10 mg + Naproxen 500 mg	0.77	-0.41
Tanezumab 5 mg (Celecoxib Exposure)	-2.85	-3.06
Tanezumab 5 mg (Naproxen Exposure)	-0.88	-1.10
Tanezumab 5 mg + Celecoxib 100 mg	1.51	1.51
Tanezumab 5 mg + Naproxen 500 mg	0.63	1.08

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

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 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 scores indicating worse condition." (NCT00809354)
Timeframe: Baseline, Week 16

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 16
Celecoxib 100 mg	3.37	-0.51
Naproxen 500 mg	3.38	-0.53
Tanezumab 10 mg (Celecoxib Exposure)	3.48	-0.64
Tanezumab 10 mg (Naproxen Exposure)	3.41	-0.63
Tanezumab 10 mg + Celecoxib 100 mg	3.41	-0.75
Tanezumab 10 mg + Naproxen 500 mg	3.39	-0.72
Tanezumab 5 mg (Celecoxib Exposure)	3.44	-0.69
Tanezumab 5 mg (Naproxen Exposure)	3.39	-0.54
Tanezumab 5 mg + Celecoxib 100 mg	3.45	-0.76
Tanezumab 5 mg + Naproxen 500 mg	3.39	-0.61

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= 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 scores indicating worse condition." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 24
Celecoxib 100 mg	-0.37	-0.49	-0.51	-0.54	-0.55
Naproxen 500 mg	-0.39	-0.43	-0.45	-0.46	-0.49
Tanezumab 10 mg (Celecoxib Exposure)	-0.33	-0.75	-0.69	-0.75	-0.59
Tanezumab 10 mg (Naproxen Exposure)	-0.42	-0.69	-0.70	-0.68	-0.54
Tanezumab 10 mg + Celecoxib 100 mg	-0.26	-0.75	-0.79	-0.83	-0.74
Tanezumab 10 mg + Naproxen 500 mg	-0.40	-0.68	-0.82	-0.84	-0.60
Tanezumab 5 mg (Celecoxib Exposure)	-0.46	-0.68	-0.63	-0.71	-0.57
Tanezumab 5 mg (Naproxen Exposure)	-0.45	-0.60	-0.58	-0.60	-0.58
Tanezumab 5 mg + Celecoxib 100 mg	-0.45	-0.80	-0.81	-0.77	-0.67
Tanezumab 5 mg + Naproxen 500 mg	-0.50	-0.74	-0.69	-0.69	-0.50

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= 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 scores indicating worse condition." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.37	-0.51	-0.54	-0.57	-0.54	-0.59	-0.57	-0.57	-0.54	-0.54
Naproxen 500 mg	-0.39	-0.44	-0.48	-0.49	-0.57	-0.57	-0.57	-0.50	-0.49	-0.47
Tanezumab 10 mg (Celecoxib Exposure)	-0.33	-0.76	-0.74	-0.84	-0.73	-0.69	-0.66	-0.67	-0.62	-0.56
Tanezumab 10 mg (Naproxen Exposure)	-0.42	-0.72	-0.77	-0.79	-0.74	-0.68	-0.66	-0.60	-0.60	-0.55
Tanezumab 10 mg + Celecoxib 100 mg	-0.26	-0.74	-0.81	-0.86	-0.77	-0.77	-0.66	-0.66	-0.59	-0.58
Tanezumab 10 mg + Naproxen 500 mg	-0.40	-0.72	-0.86	-0.91	-0.79	-0.69	-0.68	-0.56	-0.48	-0.46
Tanezumab 5 mg (Celecoxib Exposure)	-0.46	-0.70	-0.68	-0.77	-0.76	-0.66	-0.63	-0.61	-0.53	-0.51
Tanezumab 5 mg (Naproxen Exposure)	-0.45	-0.60	-0.63	-0.67	-0.63	-0.69	-0.60	-0.58	-0.53	-0.53
Tanezumab 5 mg + Celecoxib 100 mg	-0.45	-0.78	-0.81	-0.81	-0.80	-0.73	-0.73	-0.59	-0.63	-0.61
Tanezumab 5 mg + Naproxen 500 mg	-0.50	-0.76	-0.75	-0.78	-0.72	-0.64	-0.60	-0.53	-0.51	-0.49

Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Weeks 24, and 56

,,,,,,,,,

Intervention	change in percent activity impairment (Mean)
	Change at Week 24	Change at Week 56
Celecoxib 100 mg	-11.90	-11.19
Naproxen 500 mg	-10.00	-9.32
Tanezumab 10 mg (Celecoxib Exposure)	-17.84	-15.76
Tanezumab 10 mg (Naproxen Exposure)	-15.51	-14.77
Tanezumab 10 mg + Celecoxib 100 mg	-17.31	-15.86
Tanezumab 10 mg + Naproxen 500 mg	-14.96	-13.20
Tanezumab 5 mg (Celecoxib Exposure)	-17.24	-15.39
Tanezumab 5 mg (Naproxen Exposure)	-12.30	-12.12
Tanezumab 5 mg + Celecoxib 100 mg	-18.04	-18.04
Tanezumab 5 mg + Naproxen 500 mg	-13.55	-12.19

Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Weeks 24 and 56

,,,,,,,,,

Intervention	change in percent work impairment (Mean)
	Change at Week 24	Change at Week 56
Celecoxib 100 mg	-2.29	-3.02
Naproxen 500 mg	2.09	4.11
Tanezumab 10 mg (Celecoxib Exposure)	-0.22	-1.01
Tanezumab 10 mg (Naproxen Exposure)	-1.46	-1.88
Tanezumab 10 mg + Celecoxib 100 mg	-4.30	-4.30
Tanezumab 10 mg + Naproxen 500 mg	-1.35	-0.85
Tanezumab 5 mg (Celecoxib Exposure)	-10.17	-10.32
Tanezumab 5 mg (Naproxen Exposure)	-5.40	-6.08
Tanezumab 5 mg + Celecoxib 100 mg	1.25	1.25
Tanezumab 5 mg + Naproxen 500 mg	-0.75	0.77

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00809354)
Timeframe: Baseline, Week 16

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 16
Celecoxib 100 mg	6.29	-1.48
Naproxen 500 mg	6.32	-1.34
Tanezumab 10 mg (Celecoxib Exposure)	6.44	-2.12
Tanezumab 10 mg (Naproxen Exposure)	6.50	-1.97
Tanezumab 10 mg + Celecoxib 100 mg	6.27	-2.41
Tanezumab 10 mg + Naproxen 500 mg	6.33	-2.26
Tanezumab 5 mg (Celecoxib Exposure)	6.49	-2.11
Tanezumab 5 mg (Naproxen Exposure)	6.39	-1.80
Tanezumab 5 mg + Celecoxib 100 mg	6.41	-2.28
Tanezumab 5 mg + Naproxen 500 mg	6.52	-2.09

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 24
Celecoxib 100 mg	-0.93	-1.09	-1.15	-1.40	-1.63
Naproxen 500 mg	-0.90	-1.14	-1.13	-1.23	-1.32
Tanezumab 10 mg (Celecoxib Exposure)	-0.74	-1.78	-2.01	-2.20	-2.04
Tanezumab 10 mg (Naproxen Exposure)	-1.00	-1.87	-2.08	-1.95	-1.82
Tanezumab 10 mg + Celecoxib 100 mg	-0.86	-2.03	-2.36	-2.47	-2.29
Tanezumab 10 mg + Naproxen 500 mg	-0.89	-1.98	-2.18	-2.34	-1.95
Tanezumab 5 mg (Celecoxib Exposure)	-1.01	-1.69	-1.83	-2.15	-1.81
Tanezumab 5 mg (Naproxen Exposure)	-0.96	-1.68	-1.68	-1.86	-1.65
Tanezumab 5 mg + Celecoxib 100 mg	-1.08	-2.07	-2.23	-2.28	-2.10
Tanezumab 5 mg + Naproxen 500 mg	-1.27	-2.09	-2.10	-2.26	-1.83

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.93	-1.10	-1.17	-1.40	-1.50	-1.69	-1.62	-1.54	-1.45	-1.48
Naproxen 500 mg	-0.90	-1.15	-1.17	-1.32	-1.44	-1.54	-1.62	-1.44	-1.40	-1.36
Tanezumab 10 mg (Celecoxib Exposure)	-0.74	-1.73	-2.07	-2.32	-2.23	-2.25	-2.14	-1.99	-1.93	-1.72
Tanezumab 10 mg (Naproxen Exposure)	-1.00	-1.92	-2.20	-2.14	-2.19	-2.12	-2.08	-1.94	-1.93	-1.86
Tanezumab 10 mg + Celecoxib 100 mg	-0.86	-2.00	-2.34	-2.51	-2.46	-2.39	-2.14	-2.18	-2.03	-2.02
Tanezumab 10 mg + Naproxen 500 mg	-0.89	-2.05	-2.36	-2.56	-2.56	-2.33	-2.33	-2.12	-2.08	-2.03
Tanezumab 5 mg (Celecoxib Exposure)	-1.01	-1.76	-1.92	-2.29	-2.27	-2.05	-2.02	-1.98	-1.86	-1.83
Tanezumab 5 mg (Naproxen Exposure)	-0.96	-1.66	-1.76	-2.04	-2.00	-2.04	-1.94	-1.90	-1.86	-1.84
Tanezumab 5 mg + Celecoxib 100 mg	-1.08	-2.04	-2.22	-2.32	-2.34	-2.21	-2.20	-1.98	-2.05	-1.92
Tanezumab 5 mg + Naproxen 500 mg	-1.27	-2.12	-2.26	-2.45	-2.36	-2.20	-2.10	-1.88	-1.86	-1.84

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00809354)
Timeframe: Baseline, Week 16

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 16
Celecoxib 100 mg	6.47	-1.42
Naproxen 500 mg	6.32	-1.28
Tanezumab 10 mg (Celecoxib Exposure)	6.58	-2.09
Tanezumab 10 mg (Naproxen Exposure)	6.47	-1.84
Tanezumab 10 mg + Celecoxib 100 mg	6.39	-2.41
Tanezumab 10 mg + Naproxen 500 mg	6.39	-2.18
Tanezumab 5 mg (Celecoxib Exposure)	6.67	-2.13
Tanezumab 5 mg (Naproxen Exposure)	6.46	-1.80
Tanezumab 5 mg + Celecoxib 100 mg	6.57	-2.27
Tanezumab 5 mg + Naproxen 500 mg	6.57	-2.12

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: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 24
Celecoxib 100 mg	-0.90	-1.07	-1.13	-1.36	-1.57
Naproxen 500 mg	-0.90	-1.01	-1.07	-1.23	-1.30
Tanezumab 10 mg (Celecoxib Exposure)	-0.95	-1.78	-2.00	-2.13	-2.00
Tanezumab 10 mg (Naproxen Exposure)	-1.13	-1.79	-2.01	-1.87	-1.76
Tanezumab 10 mg + Celecoxib 100 mg	-1.02	-2.00	-2.30	-2.46	-2.33
Tanezumab 10 mg + Naproxen 500 mg	-1.06	-2.00	-2.15	-2.29	-1.96
Tanezumab 5 mg (Celecoxib Exposure)	-1.18	-1.73	-1.89	-2.23	-1.92
Tanezumab 5 mg (Naproxen Exposure)	-1.10	-1.71	-1.62	-1.85	-1.66
Tanezumab 5 mg + Celecoxib 100 mg	-1.21	-1.97	-2.15	-2.34	-2.08
Tanezumab 5 mg + Naproxen 500 mg	-1.44	-2.04	-2.05	-2.18	-1.76

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	6.47	-0.90	-1.09	-1.14	-1.36	-1.62	-1.57	-1.52	-1.44	-1.45
Naproxen 500 mg	6.32	-0.90	-1.04	-1.11	-1.31	-1.49	-1.53	-1.44	-1.39	-1.34
Tanezumab 10 mg (Celecoxib Exposure)	6.58	-0.95	-1.75	-2.08	-2.31	-2.24	-2.16	-2.04	-1.97	-1.78
Tanezumab 10 mg (Naproxen Exposure)	6.47	-1.13	-1.84	-2.13	-2.08	-2.08	-2.01	-1.90	-1.93	-1.84
Tanezumab 10 mg + Celecoxib 100 mg	6.39	-1.02	-1.91	-2.29	-2.50	-2.44	-2.20	-2.18	-2.05	-2.05
Tanezumab 10 mg + Naproxen 500 mg	6.39	-1.06	-2.06	-2.33	-2.50	-2.29	-2.25	-2.04	-1.96	-1.87
Tanezumab 5 mg (Celecoxib Exposure)	6.67	-1.18	-1.81	-2.02	-2.35	-2.14	-2.08	-2.06	-1.94	-1.90
Tanezumab 5 mg (Naproxen Exposure)	6.46	-1.10	-1.70	-1.69	-2.02	-2.04	-1.87	-1.87	-1.82	-1.82
Tanezumab 5 mg + Celecoxib 100 mg	6.57	-1.21	-1.95	-2.13	-2.37	-2.20	-2.22	-2.00	-2.03	-1.92
Tanezumab 5 mg + Naproxen 500 mg	6.57	-1.44	-2.08	-2.23	-2.40	-2.22	-2.15	-1.95	-1.90	-1.88

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

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24
Celecoxib 100 mg	6.38	-0.89	-1.06	-1.14	-1.33	-1.42	-1.53
Naproxen 500 mg	6.41	-0.93	-1.13	-1.15	-1.27	-1.34	-1.34
Tanezumab 10 mg (Celecoxib Exposure)	6.54	-0.98	-1.87	-2.08	-2.24	-2.17	-2.05
Tanezumab 10 mg (Naproxen Exposure)	6.54	-1.15	-1.92	-2.11	-1.98	-1.98	-1.84
Tanezumab 10 mg + Celecoxib 100 mg	6.33	-0.99	-2.10	-2.42	-2.55	-2.48	-2.33
Tanezumab 10 mg + Naproxen 500 mg	6.38	-1.04	-2.06	-2.22	-2.35	-2.28	-1.99
Tanezumab 5 mg (Celecoxib Exposure)	6.60	-1.17	-1.79	-1.93	-2.26	-2.13	-1.90
Tanezumab 5 mg (Naproxen Exposure)	6.45	-1.13	-1.74	-1.68	-1.90	-1.84	-1.70
Tanezumab 5 mg + Celecoxib 100 mg	6.48	-1.23	-2.08	-2.23	-2.35	-2.30	-2.09
Tanezumab 5 mg + Naproxen 500 mg	6.60	-1.46	-2.15	-2.14	-2.31	-2.17	-1.87

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.89	-1.07	-1.16	-1.33	-1.45	-1.58	-1.53	-1.49	-1.40	-1.42
Naproxen 500 mg	-0.93	-1.15	-1.20	-1.37	-1.45	-1.58	-1.64	-1.51	-1.48	-1.43
Tanezumab 10 mg (Celecoxib Exposure)	-0.98	-1.84	-2.15	-2.37	-2.29	-2.28	-2.20	-2.07	-2.00	-1.81
Tanezumab 10 mg (Naproxen Exposure)	-1.15	-1.98	-2.25	-2.20	-2.24	-2.18	-2.10	-1.99	-2.02	-1.93
Tanezumab 10 mg + Celecoxib 100 mg	-0.99	-2.07	-2.41	-2.59	-2.53	-2.46	-2.22	-2.20	-2.08	-2.07
Tanezumab 10 mg + Naproxen 500 mg	-1.04	-2.13	-2.41	-2.58	-2.57	-2.36	-2.35	-2.14	-2.08	-1.99
Tanezumab 5 mg (Celecoxib Exposure)	-1.17	-1.87	-2.03	-2.40	-2.31	-2.16	-2.10	-2.05	-1.94	-1.90
Tanezumab 5 mg (Naproxen Exposure)	-1.13	-1.74	-1.78	-2.08	-2.05	-2.10	-1.96	-1.94	-1.91	-1.89
Tanezumab 5 mg + Celecoxib 100 mg	-1.23	-2.06	-2.22	-2.40	-2.36	-2.22	-2.30	-2.05	-2.10	-1.98
Tanezumab 5 mg + Naproxen 500 mg	-1.46	-2.18	-2.31	-2.52	-2.48	-2.30	-2.20	-1.99	-1.96	-1.93

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, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

"WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: How much pain have you had when going up or down the stairs? Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24
Celecoxib 100 mg	7.52	-1.05	-1.29	-1.33	-1.50	-1.66	-1.73
Naproxen 500 mg	7.40	-0.94	-1.22	-1.34	-1.37	-1.53	-1.51
Tanezumab 10 mg (Celecoxib Exposure)	7.59	-1.23	-2.07	-2.26	-2.52	-2.35	-2.28
Tanezumab 10 mg (Naproxen Exposure)	7.68	-1.34	-2.13	-2.32	-2.16	-2.20	-2.01
Tanezumab 10 mg + Celecoxib 100 mg	7.54	-1.37	-2.36	-2.65	-2.79	-2.76	-2.63
Tanezumab 10 mg + Naproxen 500 mg	7.50	-1.36	-2.32	-2.53	-2.67	-2.53	-2.22
Tanezumab 5 mg (Celecoxib Exposure)	7.80	-1.41	-2.05	-2.17	-2.45	-2.39	-2.02
Tanezumab 5 mg (Naproxen Exposure)	7.55	-1.29	-1.78	-1.79	-2.09	-1.99	-1.82
Tanezumab 5 mg + Celecoxib 100 mg	7.55	-1.45	-2.43	-2.48	-2.48	-2.52	-2.47
Tanezumab 5 mg + Naproxen 500 mg	7.72	-1.67	-2.46	-2.41	-2.49	-2.35	-2.02

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, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-1.05	-1.30	-1.35	-1.55	-1.75	-1.84	-1.78	-1.76	-1.64	-1.71
Naproxen 500 mg	-0.94	-1.26	-1.35	-1.47	-1.63	-1.74	-1.70	-1.51	-1.48	-1.43
Tanezumab 10 mg (Celecoxib Exposure)	-1.23	-2.05	-2.37	-2.69	-2.53	-2.57	-2.50	-2.28	-2.24	-1.98
Tanezumab 10 mg (Naproxen Exposure)	-1.34	-2.20	-2.48	-2.40	-2.47	-2.38	-2.28	-2.21	-2.17	-2.08
Tanezumab 10 mg + Celecoxib 100 mg	-1.37	-2.37	-2.71	-2.90	-2.89	-2.83	-2.55	-2.47	-2.31	-2.34
Tanezumab 10 mg + Naproxen 500 mg	-1.36	-2.41	-2.75	-2.94	-2.88	-2.66	-2.62	-2.41	-2.29	-2.24
Tanezumab 5 mg (Celecoxib Exposure)	-1.41	-2.14	-2.27	-2.64	-2.62	-2.35	-2.27	-2.31	-2.20	-2.16
Tanezumab 5 mg (Naproxen Exposure)	-1.29	-1.80	-1.90	-2.29	-2.23	-2.26	-2.12	-2.06	-1.99	-2.00
Tanezumab 5 mg + Celecoxib 100 mg	-1.45	-2.43	-2.50	-2.57	-2.59	-2.60	-2.52	-2.26	-2.30	-2.16
Tanezumab 5 mg + Naproxen 500 mg	-1.67	-2.51	-2.62	-2.76	-2.70	-2.48	-2.43	-2.09	-2.10	-2.10

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: Baseline Observation Carried Forward (BOCF)

"WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24
Celecoxib 100 mg	6.10	-0.86	-0.95	-1.11	-1.35	-1.38	-1.55
Naproxen 500 mg	6.12	-0.80	-1.04	-1.05	-1.10	-1.23	-1.20
Tanezumab 10 mg (Celecoxib Exposure)	6.30	-0.68	-1.64	-1.84	-2.02	-1.91	-1.88
Tanezumab 10 mg (Naproxen Exposure)	6.37	-1.02	-1.88	-1.95	-1.78	-1.77	-1.65
Tanezumab 10 mg + Celecoxib 100 mg	6.14	-0.86	-1.93	-2.26	-2.25	-2.22	-2.06
Tanezumab 10 mg + Naproxen 500 mg	6.13	-0.87	-1.92	-2.09	-2.22	-2.19	-1.83
Tanezumab 5 mg (Celecoxib Exposure)	6.28	-1.04	-1.49	-1.67	-2.04	-1.94	-1.63
Tanezumab 5 mg (Naproxen Exposure)	6.22	-1.05	-1.67	-1.57	-1.74	-1.71	-1.56
Tanezumab 5 mg + Celecoxib 100 mg	6.21	-1.01	-1.88	-2.11	-2.20	-2.08	-1.96
Tanezumab 5 mg + Naproxen 500 mg	6.34	-1.31	-1.98	-1.93	-2.15	-1.95	-1.64

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, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

"WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.86	-0.96	-1.13	-1.36	-1.42	-1.64	-1.56	-1.40	-1.33	-1.36
Naproxen 500 mg	-0.80	-1.04	-1.07	-1.20	-1.33	-1.36	-1.45	-1.23	-1.22	-1.15
Tanezumab 10 mg (Celecoxib Exposure)	-0.68	-1.59	-1.85	-2.08	-1.98	-1.97	-1.80	-1.75	-1.64	-1.42
Tanezumab 10 mg (Naproxen Exposure)	-1.02	-1.92	-2.09	-1.98	-2.00	-1.94	-1.80	-1.78	-1.72	-1.64
Tanezumab 10 mg + Celecoxib 100 mg	-0.86	-1.91	-2.22	-2.27	-2.25	-2.15	-1.89	-1.89	-1.74	-1.72
Tanezumab 10 mg + Naproxen 500 mg	-0.87	-1.99	-2.26	-2.41	-2.44	-2.15	-2.12	-1.77	-1.78	-1.73
Tanezumab 5 mg (Celecoxib Exposure)	-1.04	-1.54	-1.73	-2.11	-2.03	-1.79	-1.78	-1.72	-1.62	-1.61
Tanezumab 5 mg (Naproxen Exposure)	-1.05	-1.65	-1.65	-1.93	-1.93	-1.95	-1.78	-1.69	-1.63	-1.65
Tanezumab 5 mg + Celecoxib 100 mg	-1.01	-1.84	-2.06	-2.20	-2.11	-2.04	-1.96	-1.73	-1.79	-1.67
Tanezumab 5 mg + Naproxen 500 mg	-1.31	-2.01	-2.08	-2.32	-2.20	-1.98	-1.91	-1.69	-1.68	-1.68

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

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,,,,,,,

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24
Celecoxib 100 mg	6.39	-0.82	-1.00	-1.13	-1.23	-1.34	-1.38
Naproxen 500 mg	6.60	-1.02	-1.23	-1.29	-1.40	-1.42	-1.46
Tanezumab 10 mg (Celecoxib Exposure)	6.58	-1.21	-2.05	-2.22	-2.36	-2.28	-2.10
Tanezumab 10 mg (Naproxen Exposure)	6.66	-1.32	-2.10	-2.26	-2.14	-2.15	-1.96
Tanezumab 10 mg + Celecoxib 100 mg	6.33	-1.11	-2.25	-2.60	-2.72	-2.62	-2.39
Tanezumab 10 mg + Naproxen 500 mg	6.42	-1.19	-2.19	-2.31	-2.42	-2.40	-2.04
Tanezumab 5 mg (Celecoxib Exposure)	6.62	-1.35	-1.94	-2.02	-2.38	-2.14	-1.97
Tanezumab 5 mg (Naproxen Exposure)	6.50	-1.35	-1.85	-1.76	-1.98	-1.93	-1.80
Tanezumab 5 mg + Celecoxib 100 mg	6.47	-1.41	-2.15	-2.28	-2.42	-2.35	-2.08
Tanezumab 5 mg + Naproxen 500 mg	6.70	-1.65	-2.31	-2.26	-2.49	-2.31	-1.98

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

,,,,,,,,,

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.82	-1.01	-1.15	-1.24	-1.38	-1.43	-1.41	-1.43	-1.34	-1.34
Naproxen 500 mg	-1.02	-1.26	-1.35	-1.52	-1.58	-1.75	-1.80	-1.69	-1.69	-1.63
Tanezumab 10 mg (Celecoxib Exposure)	-1.21	-2.03	-2.30	-2.49	-2.41	-2.37	-2.31	-2.20	-2.10	-1.94
Tanezumab 10 mg (Naproxen Exposure)	-1.32	-2.17	-2.43	-2.39	-2.44	-2.36	-2.23	-2.15	-2.23	-2.10
Tanezumab 10 mg + Celecoxib 100 mg	-1.11	-2.22	-2.58	-2.76	-2.68	-2.55	-2.31	-2.26	-2.17	-2.14
Tanezumab 10 mg + Naproxen 500 mg	-1.19	-2.27	-2.52	-2.68	-2.70	-2.46	-2.48	-2.24	-2.20	-2.08
Tanezumab 5 mg (Celecoxib Exposure)	-1.35	-2.04	-2.15	-2.55	-2.35	-2.28	-2.18	-2.10	-2.01	-1.97
Tanezumab 5 mg (Naproxen Exposure)	-1.35	-1.88	-1.88	-2.18	-2.16	-2.22	-2.07	-2.05	-2.03	-1.99
Tanezumab 5 mg + Celecoxib 100 mg	-1.41	-2.13	-2.30	-2.49	-2.43	-2.23	-2.46	-2.16	-2.22	-2.10
Tanezumab 5 mg + Naproxen 500 mg	-1.65	-2.34	-2.44	-2.71	-2.64	-2.48	-2.36	-2.13	-2.11	-2.07

Number of Participants With Anti-Drug Antibody (ADA) Response

Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for tanezumab were considered ADA positive. (NCT00809354)
Timeframe: Baseline, Weeks 16, 40, 24, and 56

,,,

Intervention	Participants (Count of Participants)
	Baseline	Week 16	Week 24	Week 40	Week 56
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)	2	3	2	2	2
Tanezumab 10 mg + NSAID	2	0	1	2	2
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)	3	5	4	2	3
Tanezumab 5 mg + NSAID	4	4	1	5	1

Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported. (NCT00809354)
Timeframe: Baseline, Week 16

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Intervention	Participants (Count of Participants)
	>0%	>=10%	>=20%	>=30%	>=40%	>=50%	>=60%	>=70%	>=80%	>=90%	100%
Celecoxib 100 mg	170	150	124	100	81	62	44	25	13	7	5
Naproxen 500 mg	172	153	130	102	81	56	39	22	14	7	3
Tanezumab 10 mg (Celecoxib Exposure)	182	167	150	124	114	89	68	46	34	15	8
Tanezumab 10 mg (Naproxen Exposure)	201	184	162	135	117	94	75	50	29	18	11
Tanezumab 10 mg + Celecoxib 100 mg	194	184	162	138	123	108	79	63	50	32	11
Tanezumab 10 mg + Naproxen 500 mg	203	194	174	154	132	104	82	71	45	24	10
Tanezumab 5 mg (Celecoxib Exposure)	177	162	142	122	108	89	70	51	31	19	5
Tanezumab 5 mg (Naproxen Exposure)	198	179	148	127	103	78	53	43	29	17	4
Tanezumab 5 mg + Celecoxib 100 mg	193	176	151	135	115	96	72	56	36	20	7
Tanezumab 5 mg + Naproxen 500 mg	199	183	158	139	118	96	61	42	31	19	12

Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported. (NCT00809354)
Timeframe: Baseline, Week 16

,,,,,,,,,

Intervention	Participants (Count of Participants)
	>0%	>=10%	>=20%	>=30%	>=40%	>=50%	>=60%	>=70%	>=80%	>=90%	100%
Celecoxib 100 mg	188	162	134	106	84	65	45	25	13	7	5
Naproxen 500 mg	201	175	144	112	88	61	43	24	16	7	3
Tanezumab 10 mg (Celecoxib Exposure)	202	184	167	137	120	93	72	50	38	17	8
Tanezumab 10 mg (Naproxen Exposure)	234	210	183	150	129	103	79	52	30	19	12
Tanezumab 10 mg + Celecoxib 100 mg	208	197	173	145	127	111	80	63	50	32	11
Tanezumab 10 mg + Naproxen 500 mg	245	229	201	176	150	119	92	78	48	26	12
Tanezumab 5 mg (Celecoxib Exposure)	197	179	157	133	117	97	77	53	32	20	5
Tanezumab 5 mg (Naproxen Exposure)	228	203	167	140	114	86	58	46	31	17	4
Tanezumab 5 mg + Celecoxib 100 mg	208	188	163	145	120	100	75	58	37	20	7
Tanezumab 5 mg + Naproxen 500 mg	233	215	181	159	132	105	68	47	36	21	14

Number of Participants With Intravenous (IV) Doses of Study Medication

Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received. (NCT00809354)
Timeframe: Baseline up to Week 48

,,,,,,,,,

Intervention	Participants (Count of Participants)
	Number of IV Doses: 1	Number of IV Doses: 2	Number of IV Doses: 3	Number of IV Doses: 4	Number of IV Doses: 5	Number of IV Doses: 6	Number of IV Doses: 7
Celecoxib 100 mg	22	24	12	37	73	44	44
Naproxen 500 mg	35	30	21	44	74	33	46
Tanezumab 10 mg (Celecoxib Exposure)	30	19	16	35	78	34	42
Tanezumab 10 mg (Naproxen Exposure)	36	18	28	51	70	44	41
Tanezumab 10 mg + Celecoxib 100 mg	21	12	22	48	72	38	41
Tanezumab 10 mg + Naproxen 500 mg	44	16	21	55	74	31	47
Tanezumab 5 mg (Celecoxib Exposure)	25	15	13	39	82	41	41
Tanezumab 5 mg (Naproxen Exposure)	32	19	27	41	71	45	50
Tanezumab 5 mg + Celecoxib 100 mg	22	12	18	44	84	43	33
Tanezumab 5 mg + Naproxen 500 mg	36	19	17	51	66	45	46

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. 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 Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. (NCT00809354)
Timeframe: Baseline up to Week 64

,,,,,,,,,

Intervention	Participants (Count of Participants)
	AEs	SAEs
Celecoxib 100 mg	172	21
Naproxen 500 mg	192	22
Tanezumab 10 mg (Celecoxib Exposure)	188	23
Tanezumab 10 mg (Naproxen Exposure)	211	23
Tanezumab 10 mg + Celecoxib 100 mg	193	34
Tanezumab 10 mg + Naproxen 500 mg	207	30
Tanezumab 5 mg (Celecoxib Exposure)	202	22
Tanezumab 5 mg (Naproxen Exposure)	203	22
Tanezumab 5 mg + Celecoxib 100 mg	185	26
Tanezumab 5 mg + Naproxen 500 mg	205	28

Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized. (NCT00809354)
Timeframe: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56

,,,,,,,,,

Intervention	percentage of participants (Number)
	Weeks 1-2	Weeks 3-4	Weeks 5-8	Weeks 9-12	Weeks 13-16	Weeks 17-24	Weeks 25-32	Weeks 33-40	Weeks 41-48	Weeks 49-56
Celecoxib 100 mg	63.1	66.0	67.6	68.4	70.7	69.1	74.2	71.5	72.3	71.5
Naproxen 500 mg	63.0	63.0	69.8	66.2	69.4	75.8	70.8	71.9	71.5	72.6
Tanezumab 10 mg (Celecoxib Exposure)	64.4	64.4	61.0	63.9	62.3	64.3	67.5	67.5	67.9	70.0
Tanezumab 10 mg (Naproxen Exposure)	59.4	61.7	63.8	64.2	62.5	64.6	64.9	66.3	66.0	69.1
Tanezumab 10 mg + Celecoxib 100 mg	62.7	61.1	64.3	59.3	59.7	65.6	66.4	65.2	65.0	68.1
Tanezumab 10 mg + Naproxen 500 mg	63.0	60.7	58.9	60.3	57.8	64.5	63.1	64.1	64.8	67.6
Tanezumab 5 mg (Celecoxib Exposure)	70.0	69.4	69.8	65.1	67.5	69.8	71.8	71.4	71.4	71.5
Tanezumab 5 mg (Naproxen Exposure)	60.4	63.0	66.5	65.8	65.3	68.1	66.7	68.1	69.5	71.2
Tanezumab 5 mg + Celecoxib 100 mg	60.5	59.2	62.4	60.5	62.5	60.9	63.7	62.9	63.7	66.8
Tanezumab 5 mg + Naproxen 500 mg	56.9	54.7	55.0	55.4	60.0	63.2	60.0	61.8	63.9	65.4

Percentage of Participants Who Used Rescue Medication: Observed Data

,,,,,,,,,

Intervention	percentage of participants (Number)
	Weeks 1-2	Weeks 3-4	Weeks 5-8	Weeks 9-12	Weeks 13-16	Weeks 17-24	Weeks 25-32	Weeks 33-40	Weeks 41-48	Weeks 49-56
Celecoxib 100 mg	63.2	66.0	66.7	65.9	68.8	66.3	71.2	61.6	65.1	77.5
Naproxen 500 mg	61.9	62.3	68.8	64.8	68.1	76.6	69.5	73.7	66.0	78.2
Tanezumab 10 mg (Celecoxib Exposure)	64.2	64.9	61.2	64.5	61.3	65.1	70.2	71.2	70.7	74.1
Tanezumab 10 mg (Naproxen Exposure)	59.3	61.8	64.7	65.3	63.7	67.0	67.3	69.5	62.5	71.1
Tanezumab 10 mg + Celecoxib 100 mg	62.5	60.3	63.9	57.1	57.8	66.2	66.2	61.8	52.5	79.3
Tanezumab 10 mg + Naproxen 500 mg	62.9	60.6	57.9	61.4	57.8	66.0	59.6	61.8	60.9	74.2
Tanezumab 5 mg (Celecoxib Exposure)	69.7	68.4	68.0	62.9	64.2	67.0	66.5	63.8	64.1	75.9
Tanezumab 5 mg (Naproxen Exposure)	60.5	63.3	67.7	67.8	66.7	68.9	66.0	64.4	66.7	69.2
Tanezumab 5 mg + Celecoxib 100 mg	60.2	59.3	62.5	60.3	62.3	59.4	63.5	64.8	63.3	72.4
Tanezumab 5 mg + Naproxen 500 mg	57.6	55.1	55.1	56.3	62.1	64.7	59.1	58.2	59.2	62.9

Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,,,,,,,

Intervention	percentage of participants (Number)
	Week 2: >=30% Reduction	Week 2: >=50% Reduction	Week 2: >=70% Reduction	Week 2: >=90% Reduction	Week 4: >=30% Reduction	Week 4: >=50% Reduction	Week 4: >=70% Reduction	Week 4: >=90% Reduction	Week 8: >=30% Reduction	Week 8: >=50% Reduction	Week 8: >=70% Reduction	Week 8: >=90% Reduction	Week 12: >=30% Reduction	Week 12: >=50% Reduction	Week 12: >=70% Reduction	Week 12: >=90% Reduction	Week 16: >=30% Reduction	Week 16: >=50% Reduction	Week 16: >=70% Reduction	Week 16: >=90% Reduction	Week 24: >=30% Reduction	Week 24: >=50% Reduction	Week 24: >=70% Reduction	Week 24: >=90% Reduction
Celecoxib 100 mg	24.7	11.0	5.5	1.6	31.0	18.4	7.1	1.0	30.2	18.8	9.0	2.7	36.5	21.6	9.0	2.4	39.2	24.3	9.8	2.7	41.6	25.9	11.4	3.9
Naproxen 500 mg	22.7	12.8	5.3	1.1	29.8	19.5	6.7	2.5	29.8	16.7	8.2	2.1	34.0	19.5	7.8	2.8	36.2	19.9	7.8	2.5	36.5	21.3	11.7	3.5
Tanezumab 10 mg (Celecoxib Exposure)	22.8	13.8	6.3	1.2	41.7	26.0	11.4	3.9	45.7	29.9	16.5	6.7	52.0	35.8	19.3	7.9	48.8	35.0	18.1	5.9	46.5	33.5	18.5	7.1
Tanezumab 10 mg (Naproxen Exposure)	26.8	17.1	8.7	1.4	45.6	30.0	12.5	3.1	49.8	33.8	16.4	3.8	46.3	32.8	16.0	6.3	47.0	32.8	17.4	6.3	44.9	31.7	17.4	7.3
Tanezumab 10 mg + Celecoxib 100 mg	26.0	18.5	8.3	3.1	50.4	32.7	19.3	5.5	55.9	36.2	23.2	7.1	58.3	41.7	23.6	10.6	54.3	42.5	24.8	12.6	53.5	41.3	23.6	11.8
Tanezumab 10 mg + Naproxen 500 mg	24.9	16.1	7.4	1.8	47.7	32.3	17.5	4.2	49.8	35.1	21.1	7.7	54.4	39.3	23.9	9.8	54.0	36.5	24.9	8.4	46.0	34.4	21.4	6.0
Tanezumab 5 mg (Celecoxib Exposure)	28.0	12.6	7.1	2.4	39.8	22.4	13.8	4.3	44.1	27.2	13.8	5.1	48.0	33.5	19.3	4.7	48.0	35.0	20.1	7.5	42.5	30.3	15.4	7.5
Tanezumab 5 mg (Naproxen Exposure)	28.4	17.5	5.6	1.1	40.7	24.6	11.9	2.1	43.9	27.7	13.7	4.2	45.6	30.2	14.4	6.3	44.6	27.4	15.1	6.0	40.4	27.7	14.0	6.7
Tanezumab 5 mg + Celecoxib 100 mg	30.6	17.3	7.8	1.2	49.0	30.2	16.5	6.3	51.0	33.7	18.8	6.3	53.7	37.6	20.8	7.1	52.9	37.6	22.0	7.8	47.1	35.3	21.6	7.5
Tanezumab 5 mg + Naproxen 500 mg	35.0	20.4	6.4	2.9	52.1	27.5	15.0	6.8	49.3	29.6	18.2	6.4	53.2	32.1	18.6	6.8	49.6	34.3	15.0	6.8	44.3	28.2	16.4	6.4

Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported. (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

,,,,,,,,,

Intervention	percentage of participants (Number)
	Week 2: >=30% Reduction	Week 2: >=50% Reduction	Week 2: >=70% Reduction	Week 2: >=90% Reduction	Week 4: >=30% Reduction	Week 4: >=50% Reduction	Week 4: >=70% Reduction	Week 4: >=90% Reduction	Week 8: >=30% Reduction	Week 8: >=50% Reduction	Week 8: >=70% Reduction	Week 8: >=90% Reduction	Week 12: >=30% Reduction	Week 12: >=50% Reduction	Week 12: >=70% Reduction	Week 12: >=90% Reduction	Week 16: >=30% Reduction	Week 16: >=50% Reduction	Week 16: >=70% Reduction	Week 16: >=90% Reduction	Week 24: >=30% Reduction	Week 24: >=50% Reduction	Week 24: >=70% Reduction	Week 24: >=90% Reduction	Week 32: >=30% Reduction	Week 32: >=50% Reduction	Week 32: >=70% Reduction	Week 32: >=90% Reduction	Week 40: >=30% Reduction	Week 40: >=50% Reduction	Week 40: >=70% Reduction	Week 40: >=90% Reduction	Week 48: >=30% Reduction	Week 48: >=50% Reduction	Week 48: >=70% Reduction	Week 48: >=90% Reduction	Week 56: >=30% Reduction	Week 56: >=50% Reduction	Week 56: >=70% Reduction	Week 56: >=90% Reduction
Celecoxib 100 mg	24.7	11.0	5.5	1.6	31.0	18.4	7.1	1.0	31.0	18.8	9.0	2.7	37.6	22.0	9.0	2.4	41.6	25.5	9.8	2.7	45.5	27.8	11.4	3.9	43.1	28.2	12.5	2.4	41.6	29.0	11.4	2.4	42.0	27.1	11.8	2.7	41.6	27.5	12.5	2.4
Naproxen 500 mg	22.7	12.8	5.3	1.1	30.5	20.2	6.7	2.5	31.2	17.7	8.5	2.1	36.9	21.3	8.5	2.8	39.7	21.6	8.5	2.5	42.9	25.2	13.1	4.3	44.3	27.3	12.1	5.0	42.2	25.5	9.2	3.2	40.4	23.4	11.0	3.9	40.4	22.7	9.9	3.2
Tanezumab 10 mg (Celecoxib Exposure)	22.8	13.8	6.3	1.2	41.7	26.0	11.4	3.9	48.8	30.7	17.3	7.1	57.1	37.8	20.9	8.7	53.9	36.6	19.7	6.7	53.9	35.4	20.5	7.9	51.6	36.2	21.7	9.1	50.8	31.1	20.5	5.9	49.2	31.9	18.9	5.5	46.5	28.7	16.5	4.7
Tanezumab 10 mg (Naproxen Exposure)	26.8	17.1	8.7	1.4	46.3	30.7	12.5	3.1	51.9	35.2	16.7	4.2	50.9	35.5	16.4	6.6	52.3	35.9	18.1	6.6	53.0	36.2	18.5	7.7	52.3	33.8	17.8	7.0	50.9	31.7	17.4	5.6	51.6	30.7	16.0	5.9	50.2	28.9	15.3	5.2
Tanezumab 10 mg + Celecoxib 100 mg	26.0	18.5	8.3	3.1	50.4	32.7	19.3	5.5	56.7	37.0	23.6	7.5	60.2	42.9	24.0	11.0	57.1	43.7	24.8	12.6	57.9	43.3	24.0	11.8	53.5	39.4	22.0	12.6	53.9	39.0	21.7	9.4	51.2	37.0	20.5	9.4	52.0	37.8	20.5	8.7
Tanezumab 10 mg + Naproxen 500 mg	24.9	16.1	7.4	1.8	49.8	33.7	17.9	4.6	55.1	38.9	22.8	8.4	60.7	43.5	26.0	10.5	61.8	41.8	27.4	9.1	55.8	40.7	24.6	7.4	56.5	42.5	22.1	8.4	52.6	38.2	19.3	5.6	51.9	36.5	18.9	6.7	52.6	36.1	17.9	6.3
Tanezumab 5 mg (Celecoxib Exposure)	28.0	12.6	7.1	2.4	41.3	23.6	14.2	4.7	46.5	28.7	14.6	5.9	52.8	36.6	20.5	5.1	52.4	38.2	20.9	7.9	49.2	34.3	16.5	7.9	49.6	35.4	19.3	7.9	49.2	34.3	17.7	7.5	48.4	30.7	16.1	5.9	46.9	29.9	14.2	5.1
Tanezumab 5 mg (Naproxen Exposure)	28.4	17.5	5.6	1.1	41.1	24.6	11.9	2.1	46.3	29.1	14.4	4.2	49.8	32.6	15.4	6.3	49.1	30.2	16.1	6.0	49.5	34.0	16.8	7.4	49.5	30.2	18.2	5.6	49.5	31.9	16.1	5.3	48.8	30.9	17.2	5.6	47.7	30.2	16.5	6.0
Tanezumab 5 mg + Celecoxib 100 mg	30.6	17.3	7.8	1.2	49.8	30.6	16.9	6.3	52.9	34.5	19.2	6.3	57.3	39.2	21.6	7.1	56.9	39.2	22.7	7.8	52.5	37.6	22.7	7.8	52.5	39.2	21.6	10.6	49.8	33.3	19.6	8.6	50.2	33.7	20.4	7.5	47.8	31.8	18.4	7.5
Tanezumab 5 mg + Naproxen 500 mg	35.0	20.4	6.4	2.9	53.2	27.9	15.0	6.8	53.9	31.4	19.3	6.4	59.3	34.3	19.6	7.1	56.8	37.5	16.8	7.5	54.3	33.2	19.6	7.5	53.6	33.9	16.1	5.4	51.8	30.4	15.7	4.6	51.4	30.4	15.4	4.6	51.4	28.6	16.1	4.6

Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= 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 scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported." (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, and 24

,,,,,,,,,

Intervention	percentage of participants (Number)
	Week 2	Week 4	Week 8	Week 12	Week 16	Week 24
Celecoxib 100 mg	6.3	10.6	11.8	12.2	13.4	13.0
Naproxen 500 mg	6.4	10.6	9.2	12.7	10.6	14.1
Tanezumab 10 mg (Celecoxib Exposure)	9.4	18.5	16.5	17.7	15.4	12.6
Tanezumab 10 mg (Naproxen Exposure)	10.1	13.5	18.4	17.4	19.1	18.1
Tanezumab 10 mg + Celecoxib 100 mg	5.9	14.6	17.4	22.1	18.2	20.9
Tanezumab 10 mg + Naproxen 500 mg	10.9	15.1	19.3	25.3	22.5	18.6
Tanezumab 5 mg (Celecoxib Exposure)	11.3	19.1	15.6	17.2	18.4	13.3
Tanezumab 5 mg (Naproxen Exposure)	9.9	10.2	14.1	15.5	14.8	17.6
Tanezumab 5 mg + Celecoxib 100 mg	12.5	18.8	19.6	20.8	20.0	18.8
Tanezumab 5 mg + Naproxen 500 mg	8.2	17.5	18.2	18.2	16.4	12.1

Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= 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 scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported." (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

,,,,,,,,,

Intervention	percentage of participants (Number)
	Week 2	Week 4	Week 8	Week 12	Week 16	Week 24	Week 32	Week 40	Week 48	Week 56
Celecoxib 100 mg	6.3	11.0	13.0	13.4	14.6	15.0	15.0	15.4	14.6	15.0
Naproxen 500 mg	6.4	10.6	9.9	13.8	12.0	16.3	15.5	14.1	14.5	13.4
Tanezumab 10 mg (Celecoxib Exposure)	9.4	18.9	18.5	20.9	18.1	15.4	16.5	15.0	14.6	11.8
Tanezumab 10 mg (Naproxen Exposure)	10.1	14.2	20.5	20.8	22.6	22.2	18.8	17.4	16.7	15.3
Tanezumab 10 mg + Celecoxib 100 mg	5.9	14.6	18.2	23.3	19.4	22.5	20.2	20.6	17.4	17.8
Tanezumab 10 mg + Naproxen 500 mg	10.9	16.1	20.7	27.0	24.2	21.4	23.2	18.9	16.1	15.8
Tanezumab 5 mg (Celecoxib Exposure)	11.3	20.3	17.2	19.1	21.1	16.8	19.1	18.4	17.2	14.8
Tanezumab 5 mg (Naproxen Exposure)	9.9	10.6	15.1	16.9	16.5	20.1	14.4	14.8	14.4	14.4
Tanezumab 5 mg + Celecoxib 100 mg	12.5	18.8	19.6	21.6	20.8	20.4	19.2	18.4	18.8	18.4
Tanezumab 5 mg + Naproxen 500 mg	8.2	17.9	19.3	20.4	18.9	15.4	16.4	13.9	12.9	13.6

Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, and 24

,,,,,,,,,

Intervention	percentage of participants (Number)
	Week 2	Week 4	Week 8	Week 12	Week 16	Week 24
Celecoxib 100 mg	32.4	41.0	42.6	45.3	47.3	49.2
Naproxen 500 mg	31.8	39.7	39.0	42.9	45.2	41.1
Tanezumab 10 mg (Celecoxib Exposure)	33.9	55.5	57.5	59.1	55.9	53.5
Tanezumab 10 mg (Naproxen Exposure)	35.5	57.6	58.9	56.1	53.0	50.9
Tanezumab 10 mg + Celecoxib 100 mg	33.1	57.5	65.0	65.7	63.4	59.4
Tanezumab 10 mg + Naproxen 500 mg	36.1	54.5	58.3	61.1	60.1	51.0
Tanezumab 5 mg (Celecoxib Exposure)	39.6	51.6	53.9	56.6	55.1	49.8
Tanezumab 5 mg (Naproxen Exposure)	40.4	53.0	49.5	54.0	52.3	48.1
Tanezumab 5 mg + Celecoxib 100 mg	39.5	57.4	59.4	62.1	59.8	54.7
Tanezumab 5 mg + Naproxen 500 mg	43.2	60.7	60.4	61.4	56.8	51.4

Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

,,,,,,,,,

Intervention	percentage of participants (Number)
	Week 2	Week 4	Week 8	Week 12	Week 16	Week 24	Week 32	Week 40	Week 48	Week 56
Celecoxib 100 mg	32.4	41.8	43.8	47.7	51.2	55.1	53.1	49.2	49.2	49.2
Naproxen 500 mg	31.8	41.0	41.0	46.6	49.5	48.4	52.3	50.9	49.5	50.5
Tanezumab 10 mg (Celecoxib Exposure)	33.9	55.9	61.4	65.0	62.2	63.4	56.3	56.3	55.9	53.5
Tanezumab 10 mg (Naproxen Exposure)	35.5	59.0	62.2	61.8	59.7	60.1	57.6	56.3	57.6	54.9
Tanezumab 10 mg + Celecoxib 100 mg	33.1	57.9	66.5	68.1	66.5	64.2	60.6	62.2	58.3	59.4
Tanezumab 10 mg + Naproxen 500 mg	36.1	57.6	64.2	68.4	69.1	62.2	63.2	59.0	58.0	58.0
Tanezumab 5 mg (Celecoxib Exposure)	39.6	53.1	56.3	60.9	60.5	58.6	57.4	58.2	57.4	56.6
Tanezumab 5 mg (Naproxen Exposure)	40.4	53.7	53.3	60.4	59.3	60.4	60.7	57.9	58.2	57.2
Tanezumab 5 mg + Celecoxib 100 mg	39.5	57.8	61.3	65.6	64.1	60.5	62.5	57.4	58.2	57.0
Tanezumab 5 mg + Naproxen 500 mg	43.2	62.5	65.7	68.2	65.7	63.2	61.4	58.9	57.9	57.5

Plasma Trough (Pre-dose) Concentration of Tanezumab

(NCT00809354)
Timeframe: Predose on Day 1, Weeks 16, 24, 40, and 56

,,,

Intervention	nanogram/milliliter (Mean)
	Day 1	Week 16	Week 24	Week 40	Week 56
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)	164.068	556.854	545.672	523.214	385.733
Tanezumab 10 mg + NSAID	96.4720	723.316	538.756	527.108	377.231
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)	48.4570	222.779	250.813	231.840	168.673
Tanezumab 5 mg + NSAID	102.398	255.246	271.632	263.049	138.159

Trials

1 trial available for celecoxib and Hypesthesia

Article	Year
Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Annals of the rheumatic diseases, 2015, Volume: 74, Issue:6 Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal, Hum	2015