A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 849
- 试验地点
- 94
- 主要终点
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
研究概览
简要总结
Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2
排除标准
- •pregnancy or intent to become pregnant
- •BMI greater than 39
- •other severe pain, significant cardiac, neurological or psychiatric disease
研究组 & 干预措施
1
干预措施: tanezumab 10 mg (Biological)
2
干预措施: tanezumab 5 mg (Biological)
3
干预措施: naproxen (Drug)
4
干预措施: placebo (Other)
结局指标
主要结局
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
时间窗: Baseline, Week 16
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
时间窗: Baseline, Week 16
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
时间窗: Baseline, Week 16
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.
次要结局
- 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)(Baseline, Weeks 2, 4, 8, and 12)
- 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)(Baseline, Weeks 2, 4, 8, 12, and 16)
- 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)(Baseline, Weeks 2, 4, 8, and 12)
- Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)(Baseline, Weeks 2, 4, 8, and 12)
- Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)(Baseline, Weeks 2, 4, 8, 12, and 16)
- 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)(Weeks 2, 4, 8, 12, and 16)
- Percentage of Participants Who Used Rescue Medication(Weeks 2, 4, 8, 12, and 16)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline (Day 1) up to Week 24)
- 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)(Baseline, Weeks 2, 4, 8, 12, and 16)
- 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)(Weeks 2, 4, 8, 12, and 16)
- Time to Discontinuation Due to Lack of Efficacy(Baseline up to Week 16)
- 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)(Baseline, Weeks 2, 4, 8, 12, and 16)
- 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)(Weeks 2, 4, 8, 12, and 16)
- 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)(Weeks 2, 4, 8, 12, and 16)
- Amount of Rescue Medication Taken(Weeks 2, 4, 8, 12, and 16)
- 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)(Weeks 2, 4, 8, 12, and 16)
- 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)(Baseline up to Week 16)
- 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)(Weeks 2, 4, 8, 12, and 16)
- 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)(Baseline up to Week 16)
- 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)(Baseline, Weeks 2, 4, 8, 12, and 16)
- 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)(Baseline, Weeks 2, 4, 8, 12, and 16)
- Number of Participants With Abnormal Physical Examinations Findings(Baseline (Day 1))
- 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)(Baseline, Weeks 2, 4, 8, 12, and 16)
- 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)(Baseline, Weeks 12, and 16)
- Duration of Rescue Medication Use(Weeks 2, 4, 8, 12, and 16)
- 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)(Baseline, Weeks 2, 4, 8, 12, and 16)
- Number of Participants With Abnormal Electrocardiogram (ECG) Findings(Baseline (Day 1) up to Week 24)
- Number of Participants With Adverse Events Associated With Vital Sign Measurements(Baseline (Day 1) up to Week 24)
- 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)(Baseline, Weeks 12, and 16)
- Number of Participants With Positive Anti-Drug Antibody (ADA) Level(Baseline, Weeks 8, 16, and 24)
- Number of Participants With Laboratory Test Abnormalities(Baseline (Day 1) up to Week 24)
- Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24(Baseline, Weeks 2, 4, 8, 12, 16, and 24)