Retreatment of Recurrent Dupuytren's Contractures

Dupuytren's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498640
• Other study ID #: AUX-CC-862
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2011
• Last updated: September 7, 2017
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2017
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 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

4. Be able to comply with the study visit schedule as specified in the protocol

Exclusion Criteria:

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 equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before injection of AA4500

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Disease

Intervention

Biological:
• Collagenase clostridium histolyticum
up to three 0.58 mg injections

Locations

Country	Name	City	State
Australia	Peninsula Private Hospital	Kippa Ring	Queensland
Australia	Emeritus Research	Malvern East	Victoria
Australia	AusTrials Sherwood	Sherwood	Queensland
Sweden	Uppsala Akademiska University Hospital	Uppsala	SE
United Kingdom	Pulvertaft Hand Center	Derby	GB
United Kingdom	Newcastle Upon Tyne Hospitals	Newcastle	GB
United States	Hand Microsurgery and Reconstructive Orthopaedics	Erie	Pennsylvania
United States	The Indiana Hand to Shoulder Center	Indianapolis	Indiana
United States	Marquette General Health System	Marquette	Michigan
United States	East River Professional Building	New York	New York
United States	Health Reserarch Institute	Oklahoma City	Oklahoma
United States	HOPE Research Institute	Phoenix	Arizona
United States	Rockford Orthopedic Associates	Rockford	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Physician Global Assessment of Improvement	Physician global assessment of change (improvement) in subject's Dupuytren's contracture	30 days after last injection
Secondary	Subject Global Assessment of Satisfaction	Subject global assessment of overall treatment satisfaction	30 days after last injection
Secondary	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