Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Total Passive Extension Deficit (TPED) at Baseline for First Injection
研究概览
简要总结
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb.
- •Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
排除标准
- •Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren's contracture including needle aponeurotomy or any surgical procedure
- •On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection
- •Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
研究组 & 干预措施
Xiapex Injection
干预措施: Xiapex (Drug)
结局指标
主要结局
Total Passive Extension Deficit (TPED) at Baseline for First Injection
时间窗: Baseline for first injection
TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Baseline for Second Injection
时间窗: Baseline for second injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Baseline for Third Injection
时间窗: Baseline for third injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection
时间窗: Baseline for fourth injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 1 After First Injection
时间窗: Day 1 after first injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 7 After First Injection
时间窗: Day 7 after first injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 30 After First Injection
时间窗: Day 30 after first injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 1 After Second Injection
时间窗: Day 1 after second injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 7 After Second Injection
时间窗: Day 7 after second injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 30 After Second Injection
时间窗: Day 30 after second injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 1 After Third Injection
时间窗: Day 1 after third injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 7 After Third Injection
时间窗: Day 7 after third injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 30 After Third Injection
时间窗: Day 30 after third injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection
时间窗: Day 1 after fourth injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection
时间窗: Day 7 after fourth injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection
时间窗: Day 30 after fourth injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 90 After Last Injection
时间窗: Day 90 after last injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
Total Passive Extension Deficit (TPED) at Day 180 After Last Injection
时间窗: Day 180 after last injection
TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.
次要结局
- Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints(Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection)
- Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection(Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection)
- Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection(Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection)
- Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints(Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection)
- Participant Global Assessment of Treatment Satisfaction and Disease Severity(Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection)
- Physician Global Assessment of Treatment Satisfaction and Disease Severity(Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection)
- Number of Participants With Type of Concomitant Pain Medication Used(Screening up to Day 180 after last injection)
- Number of Days of Concomitant Pain Medication Usage(Screening up to Day 180 after last injection)
- Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire(C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30)
- Time to Recovery(Up to Day 30 after first, second and third injection)
- Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score(Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection)
- Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire(Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection)
- Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire(Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection)
- Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire(Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection)