Phase 3
Completed N=849
Tanezumab in Osteoarthritis of the Hip or Knee (2)
Source: ClinicalTrials.gov NCT00863304 ↗Enrolled (actual)
849
Serious AEs
2.4%
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) — 7.41; 7.27; 7.37; 7.30 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
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) |
7.41; 7.27; 7.37; 7.30; -2.14; -3.32 | <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) |
7.04; 6.83; 7.09; 6.95; -1.75; -3.01 | <0.001 sig |
| PRIMARY Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) |
3.46; 3.36; 3.40; 3.48; -0.49; -0.80 | <0.001 sig |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF) |
-2.11; -2.64; -2.42; -2.92; -2.29; -3.48 | 0.029 sig |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
7.41; 7.27; 7.37; 7.30; -2.11; -2.64 | 0.029 sig |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) |
7.04; 6.83; 7.09; 6.95; -1.60; -2.34 | 0.001 sig |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
-1.60; -2.34; -2.33; -2.52; -1.84; -3.09 | 0.001 sig |
| SECONDARY Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) |
-0.52; -0.65; -0.60; -0.88; -0.55; -0.90 | 0.012 sig |
| SECONDARY Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
-0.52; -0.65; -0.60; -0.88; -0.55; -0.91 | 0.012 sig |
| SECONDARY Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
49.8; 59.7; 55.3; 68.6; 45.9; 72.5 | — |
| SECONDARY Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
49.8; 59.7; 55.3; 68.6; 48.8; 74.4 | — |
| SECONDARY Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
43.1; 50.2; 45.2; 56.5; 26.3; 37.0 | — |
| SECONDARY Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
43.1; 50.2; 45.2; 56.5; 26.3; 37.0 | — |
| SECONDARY Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
13.4; 14.7; 16.8; 23.2; 12.4; 24.2 | — |
| SECONDARY Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF) |
13.4; 14.7; 16.8; 23.2; 12.9; 24.6 | — |
| SECONDARY Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) |
54.1; 71.6; 64.9; 67.1; 51.2; 69.7 | — |
| SECONDARY Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) |
81.3; 89.6; 86.5; 85.0; 72.7; 83.4 | — |
| SECONDARY Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF) |
-1.11; -1.75; -1.70; -2.02; -1.43; -2.34 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
7.19; 7.07; 7.11; 6.96; -1.54; -2.52 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
7.21; 7.06; 7.19; 7.07; -1.75; -2.50 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
7.36; 7.16; 7.23; 7.22; -2.14; -2.64 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) |
8.33; 8.05; 8.22; 8.24; -1.97; -2.84 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF) |
1.11; 3.51; 4.02; 3.05; 1.43; 5.02 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF) |
0.01; 0.10; 0.09; 0.01; 0.07; 0.16 | — |
| SECONDARY Time to Discontinuation Due to Lack of Efficacy |
87.78; 80.12; 84.62; 72.87 | — |
| SECONDARY Percentage of Participants Who Used Rescue Medication |
61.6; 63.3; 68.9; 46.6; 52.5; 47.1 | — |
| SECONDARY Duration of Rescue Medication Use |
1; 2; 2; 0; 1; 0 | — |
| SECONDARY Amount of Rescue Medication Taken |
3967.98; 3661.84; 3325.24; 2069.71; 3392.16; 2442.31 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
85; 101; 101; 110; 4; 3 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
145; 145; 144; 164 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram (ECG) Findings |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24 |
1.52; 1.38; 0.92; 1.14; -0.22; -0.21 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibody (ADA) Level |
0; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Physical Examinations Findings |
19; 12; 11; 15; 5; 11 | — |
| SECONDARY Number of Participants With Adverse Events Associated With Vital Sign Measurements |
3; 6; 5; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Osteoarthritis of the hip or 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, neurological or psychiatric disease
Data sourced from ClinicalTrials.gov (NCT00863304) 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.