Retreatment of Recurrent Dupuytren's Contractures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dupuytren's Disease

Intervention / Treatment
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* Biological: Collagenase clostridium histolyticum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XIAFLEX/XIAPEX MP Joint<br>Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord | Biological: Collagenase clostridium histolyticum<br>* up to three 0.58 mg injections<br>* Other names: AA4500;|
| Experimental: XIAFLEX/XIAPEX PIP Joint<br>Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord | Biological: Collagenase clostridium histolyticum<br>* up to three 0.58 mg injections<br>* Other names: AA4500;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | 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 | 30 days after last injection | 
| Percent Change From Baseline in Degree of Contracture | Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees | Baseline and 30 days after last injection | 
| Change in Range of Motion | Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees | Baseline and 30 days after last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Global Assessment of Improvement | Physician global assessment of change (improvement) in subject's Dupuytren's contracture | 30 days after last injection | 
| Subject Global Assessment of Satisfaction | Subject global assessment of overall treatment satisfaction | 30 days after last injection | 
| Recurrence of Contracture | Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points. | Day 365 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XIAFLEX, XIAPEX, Dupuytren's disease, contracture