Retreatment of Recurrent Dupuytren's Contractures
- Conditions
- Dupuytren's Disease
- Interventions
- Biological: Collagenase clostridium histolyticum
- Registration Number
- NCT01498640
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description XIAFLEX/XIAPEX MP Joint Collagenase clostridium histolyticum Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord XIAFLEX/XIAPEX PIP Joint Collagenase clostridium histolyticum Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
- Primary Outcome Measures
Name Time Method Clinical Success 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 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 Baseline and 30 days after last injection Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
- Secondary Outcome Measures
Name Time Method Subject Global Assessment of Satisfaction 30 days after last injection Subject global assessment of overall treatment satisfaction
Recurrence of Contracture Day 365 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.
Physician Global Assessment of Improvement 30 days after last injection Physician global assessment of change (improvement) in subject's Dupuytren's contracture
Trial Locations
- Locations (13)
The Indiana Hand to Shoulder Center
🇺🇸Indianapolis, Indiana, United States
Hand Microsurgery and Reconstructive Orthopaedics
🇺🇸Erie, Pennsylvania, United States
East River Professional Building
🇺🇸New York, New York, United States
Marquette General Health System
🇺🇸Marquette, Michigan, United States
Rockford Orthopedic Associates
🇺🇸Rockford, Illinois, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Health Reserarch Institute
🇺🇸Oklahoma City, Oklahoma, United States
Peninsula Private Hospital
🇦🇺Kippa Ring, Queensland, Australia
Uppsala Akademiska University Hospital
🇸🇪Uppsala, SE, Sweden
AusTrials Sherwood
🇦🇺Sherwood, Queensland, Australia
Emeritus Research
🇦🇺Malvern East, Victoria, Australia
Pulvertaft Hand Center
🇬🇧Derby, GB, United Kingdom
Newcastle Upon Tyne Hospitals
🇬🇧Newcastle, GB, United Kingdom