A Phase 3, Open-Label Extension 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
- 286
- 试验地点
- 15
- 主要终点
- Reduction in Contracture to 5° or Less
研究概览
简要总结
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.
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 only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
- •Were judged to be in good health.
- •Must have participated in protocol AUX-CC-857 (NCT00528606).
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: AA4500 (Biological)
结局指标
主要结局
Reduction in Contracture to 5° or Less
时间窗: Within 30 days after last injection
Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
次要结局
- Change From Baseline Range of Motion After the Last Injection(Baseline, Day 30 after last injection)
- Clinical Success After the First Injection(Within 30 days after first injection)
- Percent Reduction From Baseline Contracture After the Last Injection(Baseline, Day 30 after last injection)
- Time to Reach Clinical Success(Within 30 days after last injection)
- Clinical Improvement After the Last Injection(Baseline, within 30 days after last injection)
- Clinical Improvement After the First Injection(Baseline, within 30 days after first injection)
- Percent Reduction From Baseline Contracture After the First Injection(Baseline, Day 30 after first injection)
- Change From Baseline Range of Motion After the First Injection(Baseline, Day 30 after first injection)