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

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. - AA4500 Re-treatment Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005065-21-GB

Enrollment

150

Registered

2012-02-27

Start date

2012-05-04

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren's contracture MedDRA version: 20.0 Level: PT Classification code 10013872 Term: Dupuytren's contracture System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Collagenase clostridium histolyticum Product Code: AA4500 Pharmaceutical Form: Lyophilisate and solvent for solution for injection Current

Eligibility

Sex/Gender

All

Inclusion criteria

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 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. ;Timepoint(s) of evaluation of this end point: Day 30 after last injection and day 365	—

Measure

Time frame

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. ;Timepoint(s) of evaluation of this end point: Day 30 after last injection and day 365

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Australia, Sweden, United Kingdom, United States

Contacts

Public ContactVP, Clinical Research International

Auxilium UK Limited

njones@auxilium.com441443421707

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026