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Phase 3 N=627 Randomized Double-blind Treatment

Tanezumab in Osteoarthritis Of The Hip

Arthritis · Osteoarthritis · Osteoarthritis, Hip

Bottom Line

View on ClinicalTrials.gov: NCT00744471 ↗
Enrolled (actual)
627
Serious AEs
3.9%
Results posted
Feb 2021
Primary outcome: Primary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) — 7.26; 7.20; 7.24; 7.33 Units on a scale — p=<0.001

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
Mar 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)		 7.26; 7.20; 7.24; 7.33; -1.65; -2.86 <0.001 sig
PRIMARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)		 6.79; 6.79; 6.82; 6.83; -1.39; -2.54 <0.001 sig
PRIMARY
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)		 3.47; 3.55; 3.51; 3.46; -0.34; -0.67 0.001 sig
SECONDARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)		 -1.94; -3.32; -3.71; -3.30; -1.92; -3.46 <0.001 sig
SECONDARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)		 -1.94; -3.32; -3.71; -3.30; -2.02; -3.55 <0.001 sig
SECONDARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)		 -1.56; -2.88; -3.32; -2.90; -1.44; -3.06 <0.001 sig
SECONDARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)		 -1.56; -2.88; -3.32; -2.90; -1.51; -3.13 <0.001 sig
SECONDARY
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)		 -0.41; -0.83; -1.08; -0.81; -0.44; -0.93 <0.001 sig
SECONDARY
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)		 -0.41; -0.83; -1.08; -0.81; -0.45; -0.95 <0.001 sig
SECONDARY
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)		 45.5; 68.7; 80.0; 67.7; 45.5; 71.3 —
SECONDARY
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)		 45.5; 68.7; 80.0; 67.7; 48.1; 73.3 —
SECONDARY
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward		 38.3; 64.2; 70.7; 58.3; 26.0; 49.0 —
SECONDARY
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)		 38.3; 64.2; 70.7; 58.3; 26.0; 49.0 —
SECONDARY
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)		 9.7; 24.0; 32.0; 24.5; 10.4; 25.3 —
SECONDARY
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)		 9.7; 24.0; 32.0; 24.5; 10.4; 26.0 —
SECONDARY
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)		 44.8; 68.2; 78.7; 72.4; 40.9; 64.9 —
SECONDARY
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)		 79.2; 87.4; 89.3; 93.6; 63.6; 81.5 —
SECONDARY
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)		 6.61; 6.44; 6.71; 6.55; -1.24; -1.89 —
SECONDARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)		 7.18; 7.17; 7.02; 7.23; -1.69; -3.13 —
SECONDARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)		 7.08; 7.05; 7.03; 7.13; -1.73; -3.13 —
SECONDARY
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)		 7.26; 7.21; 7.25; 7.32; -1.83; -3.31 —
SECONDARY
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)		 7.99; 7.94; 7.83; 7.89; -1.88; -3.42 —
SECONDARY
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)		 64.81; 67.04; 63.74; 64.26; 30.56; 29.66 —
SECONDARY
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)		 -0.03; 0.18; 0.06; 0.11; -1.90; -1.99 —
SECONDARY
Time to Discontinuation Due to Lack of Efficacy		 NA; NA; NA; NA —
SECONDARY
Percentage of Participants Who Used Rescue Medication		 46.1; 37.1; 36.1; 37.4; 45.8; 26.5 —
SECONDARY
Duration of Rescue Medication Use		 2.0; 1.0; 1.0; 1.0; 2.0; 1.0 —
SECONDARY
Amount of Rescue Medication Taken		 3917.76; 3205.30; 3346.94; 3306.45; 3676.47; 2437.09 —
SECONDARY
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)		 68; 90; 84; 89; 6; 5 —
SECONDARY
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24		 -0.09; -0.22; -0.21; -0.10; -0.03; 0.03 —

Summary

The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients

Eligibility Criteria

Inclusion Criteria

  • Osteoarthritis of the hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement 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
  • BMI greater than 39
  • Other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00744471). 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.

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