A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 14
- 主要终点
- Reduction in Contracture to 5° or Less
研究概览
简要总结
This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease 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 evaluation and injection were enrolled.
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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 advanced Dupuytren's disease, 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.
- •Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- •Were naïve to AA4500 treatment or had received one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-
- •Were judged to be in good health.
排除标准
- •Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- •Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
- •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
AA4500 0.58 mg
干预措施: collagenase clostridium histolyticum (Biological)
结局指标
主要结局
Reduction in Contracture to 5° or Less
时间窗: Within 30 days after the last injection
The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection
次要结局
- Time to Reach Clinical Success(First evaluation visit on which clinical success is achieved through the Day 30 evaluation)
- Clinical Success After the First Injection(Within 30 days after first injection)
- Clinical Improvement After the First Injection(Baseline; within 30 days after first injection)
- Clinical Improvement After the Last Injection(Baseline; within 30 days after last injection)
- Percent Reduction From Baseline Contracture After the Last Injection(Baseline, within 30 days after last injection)
- Percent Reduction From Baseline Contracture After the First Injection(Baseline; within 30 days after first injection)
- Change From Baseline Range of Motion After the Last Injection(Baseline, 30 days after last injection)
- Change From Baseline Range of Motion After the First Injection(Baseline; within 30 days after first injection)