Phase 3
Completed N=697
Tanezumab in Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT00733902 ↗Enrolled (actual)
697
Serious AEs
1.9%
Results posted
Mar 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) — 7.05; 7.16; 7.19; 6.99 units on a scale — p=0.015
◆ Published Evidence
Highly cited
149citations · ~15 / year
When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program.
Summary
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
Linked Publications (3)
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When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program.
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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) |
7.05; 7.16; 7.19; 6.99; -2.51; -3.27 | 0.015 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) |
6.64; 6.86; 6.91; 6.69; -2.06; -2.93 | 0.009 sig |
| PRIMARY Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) |
3.40; 3.47; 3.45; 3.45; -0.51; -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, 12, 24: Baseline Observation Carried Forward (BOCF) |
-2.75; -3.08; -2.52; -2.68; -2.72; -3.70 | 0.326 |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) |
7.05; 7.16; 7.19; 6.99; -2.75; -3.08 | 0.326 |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF) |
-2.17; -2.85; -2.34; -2.61; -2.13; -3.23 | 0.044 sig |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) |
6.64; 6.86; 6.91; 6.69; -2.17; -2.85 | 0.044 sig |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF) |
6.94; 6.98; 7.05; 6.89; -2.09; -2.91 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) |
6.94; 6.98; 7.05; 6.89; -2.09; -2.91 | — |
| SECONDARY Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF) |
-0.55; -0.91; -0.63; -0.82; -0.55; -1.04 | <0.001 sig |
| SECONDARY Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) |
3.40; 3.47; 3.45; 3.45; -0.55; -0.91 | <0.001 sig |
| SECONDARY Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) |
62.3; 68.2; 60.9; 68.2; 57.1; 70.8 | — |
| SECONDARY Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) |
62.3; 68.2; 60.9; 68.2; 61.7; 74.0 | — |
| SECONDARY Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) |
57.8; 60.4; 50.6; 55.2; 40.9; 44.8 | — |
| SECONDARY Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) |
57.8; 60.4; 50.6; 55.2; 40.9; 44.8 | — |
| SECONDARY Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF) |
11.7; 24.0; 14.7; 21.4; 10.4; 31.8 | — |
| SECONDARY Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF) |
11.7; 24.0; 14.7; 21.4; 11.7; 32.5 | — |
| SECONDARY Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) |
61.0; 79.2; 79.5; 76.0; 59.7; 75.3 | — |
| SECONDARY Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) |
84.4; 87.7; 92.9; 92.9; 77.9; 83.1 | — |
| SECONDARY Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF) |
6.38; 6.70; 6.74; 6.55; -1.21; -1.87 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF) |
6.88; 7.00; 7.05; 6.86; -2.34; -2.95 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF) |
6.90; 7.18; 7.28; 6.96; 8.10; 8.21 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF) |
67.16; 65.39; 65.99; 69.38; 32.64; 30.52 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF) |
0.23; 0.21; 0.34; 0.30; -1.79; -1.86 | — |
| SECONDARY Time to Discontinuation Due to Lack of Efficacy |
NA; NA; NA; NA | — |
| SECONDARY Percentage of Participants Who Used Rescue Medications |
68.2; 63.0; 65.4; 66.0; 55.2; 40.3 | — |
| SECONDARY Duration of Rescue Medication Use |
1.5; 1.0; 2.0; 1.0; 1.0; 0.0 | — |
| SECONDARY Amount of Rescue Medication Taken |
3493.51; 2818.18; 3419.87; 2993.46; 2691.56; 1925.32 | — |
Eligibility Criteria
Inclusion Criteria
- Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
- Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
- Pain level and function levels as required by the protocol at Screening and Baseline.
- Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
- Must agree to the contraceptive requirements of the protocol if applicable.
- Must agree to the treatment plan, scheduled visits, and procedures of the protocol.
Exclusion Criteria
- Pregnancy or intent to become pregnant during the study
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
Data sourced from ClinicalTrials.gov (NCT00733902) 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.