Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,650
- 试验地点
- 69
- 主要终点
- Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.
The secondary objectives of the study are:
- To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
- To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
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
- Triple (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dosing regimen 1
干预措施: Fasinumab (Drug)
Dosing regimen 1
干预措施: Matching placebo (Drug)
Dosing regimen 2
干预措施: Diclofenac (Other)
Dosing regimen 2
干预措施: Matching placebo (Drug)
Dosing regimen 3
干预措施: Celecoxib (Other)
Dosing regimen 3
干预措施: Matching placebo (Drug)
Dosing regimen 4
干预措施: Matching placebo (Drug)
结局指标
主要结局
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
时间窗: Baseline up to Week 24
WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
时间窗: Baseline up to Week 24
Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was 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.
次要结局
- Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo(Baseline up to Week 24)
- Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo(Baseline up to Week 24)
- Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs(Baseline up to Week 24)
- Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs(Baseline up to Week 24)
- Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs(Baseline up to Week 24)
- Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale(Baseline up to Week 24)
- Number of Participants With Adjudicated Arthropathy (AA) Events(Baseline up to follow-up period (Week 44))
- Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria(Baseline up to follow-up period (Week 44))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Baseline up to follow-up period (Week 44))
- Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events(Baseline up to follow-up period (Week 44))
- Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)(Baseline up to Week 44)
- Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24(Baseline up to Week 24)
- Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44(Baseline up to Week 44)
- Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)(At Week 72)
- Serum Concentrations of Functional Fasinumab(At Weeks 0, 4, 8, 16, 24 and 44)
- Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development(Baseline up to Week 44)