Phase 3
N=697
Tanezumab in Osteoarthritis of the Knee
Arthritis · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00733902 ↗Enrolled (actual)
697
Serious AEs
1.9%
Results posted
Mar 2021
Primary outcome: 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 units on a scale — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tanezumab (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2009
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 | — |
Summary
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
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). 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.