A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 308
- 试验地点
- 15
- 主要终点
- Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection
研究概览
简要总结
This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or placebo.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.
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
- •Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord that had never been treated with AA
- •Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- •Judged to be in good health.
排除标准
- •Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- •Had received a treatment for Dupuytren's contracture, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
- •Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
研究组 & 干预措施
Placebo
干预措施: Placebo (Biological)
AA4500 0.58 mg
干预措施: collagenase clostridium histolyticum (Biological)
结局指标
主要结局
Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection
时间窗: Within 30 days after the last injection
The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection. The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
次要结局
- Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection(Within 30 days after first injection)
- Clinical Improvement After the First Injection(Baseline; within 30 days after the first injection)
- Percent Reduction From Baseline Contracture After the First Injection(Baseline, within 30 days after the first injection)
- Change From Baseline Range of Motion After the First Injection(Baseline; within 30 days after the first injection)
- Clinical Improvement After the Last Injection(Baseline; within 30 days after the last injection)
- Percent Reduction From Baseline Contracture After the Last Injection(Baseline; within 30 days after the last injection)
- Change From Baseline Range of Motion After the Last Injection(Baselin; within 30 days after the last injection)
- Time to First Achieve Success After the Last Injection(Last evaluation visit on which clinical success is achieved through the Day 30 evaluation)