To treat contractures that have come back when they were previously successfully treated with AA4500 in a prior clinical study

Conditions: Dupuytren's contracture
MedDRA version: 14.1Level: PTClassification code 10013872Term: Dupuytren's contractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-005065-21-SE

Lead Sponsor: Auxilium UK Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

To qualify for the study a subject must:
1. Provide written informed consent
2. Be currently participating in the AUX-CC-860 follow-up study
3. Have at least one joint with all of the following:
• The joint was effectively treated (had a correction to 5° 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°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
4. Be able to comply with the study visit schedule as specified in the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

A subject will be excluded from study participation if he/she:
1. Is a pregnant or lactating female or female intending to become pregnant during the study
2. Has hypersensitivity to AA4500 or any of the AA4500 excipients
3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for = 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs [NSAIDs]) within 7 days before injection of AA4500

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: N/A;Primary end point(s): The efficacy variables include degree of flexion deformity of the recurrent joint as measured by finger goniometry and range of motion, physician assessment of treatment of the recurrent joint and subject satisfaction with treatment of the recurrent joint.<br>;Timepoint(s) of evaluation of this end point: Day 30 after last injection and day 365

Secondary Outcome Measures