Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 25
- 主要终点
- Clinical Success
研究概览
简要总结
The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.
详细描述
Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.
Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Provide written informed consent
- •Be currently participating in the AUX-CC-860 follow-up study
- •Have at least one joint with all of the following:
- •The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
- •The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
- •A palpable cord is present in the joint to be treated
- •Be able to comply with the study visit schedule as specified in the protocol
排除标准
- •Is a pregnant or lactating female or female intending to become pregnant during the study
- •Has hypersensitivity to AA4500 or any of the AA4500 excipients
- •Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before injection of AA4500
研究组 & 干预措施
XIAFLEX/XIAPEX MP Joint
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
干预措施: Collagenase clostridium histolyticum (Biological)
XIAFLEX/XIAPEX PIP Joint
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
干预措施: Collagenase clostridium histolyticum (Biological)
结局指标
主要结局
Clinical Success
时间窗: 30 days after last injection
Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500
Percent Change From Baseline in Degree of Contracture
时间窗: Baseline and 30 days after last injection
Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Change in Range of Motion
时间窗: Baseline and 30 days after last injection
Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
次要结局
- Subject Global Assessment of Satisfaction(30 days after last injection)
- Recurrence of Contracture(Day 365)
- Physician Global Assessment of Improvement(30 days after last injection)