Phase 3
Completed N=832
Tanezumab In Osteoarthritis Of The Knee (2)
Source: ClinicalTrials.gov NCT00830063 ↗Enrolled (actual)
832
Serious AEs
3.1%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) — 7.21; 7.30; 7.25; 7.18 units on a scale — p=<0.001
◆ Published Evidence
Established
86citations · ~7 / year
Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen.
Summary
The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.
Linked Publications (3)
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Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen.
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Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip.
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Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) |
7.21; 7.30; 7.25; 7.18; -2.23; -3.55 | <0.001 sig |
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF) |
6.85; 6.86; 6.86; 6.86; -1.88; -3.18 | <0.001 sig |
| PRIMARY Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) |
3.41; 3.41; 3.39; 3.44; -0.53; -0.87 | <0.001 sig |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) |
-2.34; -2.61; -2.95; -3.12; -2.36; -3.59 | 0.355 |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) |
7.21; 7.30; 7.25; 7.18; -2.34; -2.61 | 0.355 |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) |
-1.92; -2.44; -2.80; -2.66; -1.92; -3.07 | 0.355 |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) |
6.85; 6.86; 6.86; 6.86; -1.92; -2.44 | 0.026 sig |
| SECONDARY Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) |
-0.53; -0.69; -0.68; -0.89; -0.52; -1.02 | 0.045 sig |
| SECONDARY Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) |
3.41; 3.41; 3.39; 3.44; -0.53; -0.69 | 0.045 sig |
| SECONDARY Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF) |
55.3; 61.9; 69.8; 67.0; 53.3; 72.3 | — |
| SECONDARY Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF) |
55.3; 61.9; 69.8; 67.0; 56.3; 73.8 | — |
| SECONDARY Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF) |
46.7; 52.0; 58.4; 60.5; 29.6; 36.1 | — |
| SECONDARY Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF) |
46.7; 52.0; 58.4; 60.5; 29.6; 36.1 | — |
| SECONDARY Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF) |
11.0; 17.8; 16.8; 25.5; 9.0; 29.7 | — |
| SECONDARY Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF) |
11.0; 17.8; 16.8; 25.5; 9.0; 29.7 | — |
| SECONDARY Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) |
57.3; 73.3; 69.3; 71.5; 54.3; 71.8 | — |
| SECONDARY Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) |
82.4; 87.6; 92.1; 91.5; 75.4; 83.2 | — |
| SECONDARY Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
6.46; 6.51; 6.58; 6.70; -1.23; -1.80 | — |
| SECONDARY Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
6.43; 6.51; 6.60; 6.69; -1.25; -1.84 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
7.04; 7.17; 7.04; 7.02; -1.69; -2.63 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
7.04; 7.17; 7.04; 7.02; -1.69; -2.63 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
7.03; 7.11; 7.05; 7.02; -1.99; -2.56 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
7.03; 7.11; 7.05; 7.02; -1.99; -2.56 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
7.22; 7.16; 7.08; 7.04; -2.40; -2.52 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
7.22; 7.16; 7.08; 7.04; -2.40; -2.52 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
8.24; 8.29; 8.15; 8.30; -2.19; -2.86 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
8.24; 8.29; 8.15; 8.30; -2.19; -2.86 | — |
| SECONDARY Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF) |
66.03; 67.19; 67.64; 65.16; 4.13; 6.33 | — |
| SECONDARY Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF) |
66.03; 67.19; 67.64; 65.16; 4.13; 6.33 | — |
| SECONDARY Time to Discontinuation Due to Lack of Efficacy |
NA; NA; NA; NA | — |
| SECONDARY Percentage of Participants Who Used Rescue Medication |
62.5; 47.3; 58.6; 49.7; 59.5; 35.3 | — |
| SECONDARY Number of Days Participants Used Rescue Medication |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Amount of Rescue Medication Taken |
3512.50; 2644.28; 2546.80; 2025.13; 3492.50; 1773.63 | — |
Eligibility Criteria
Inclusion Criteria
- Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2
Exclusion Criteria
- Pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurologic or cardiac disease
Data sourced from ClinicalTrials.gov (NCT00830063) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.