Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

Advanced Dupuytren's Disease Clinical Trial

— JOINT-I  

Official title:

A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528840
• Other study ID #: AUX-CC-856
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2007
• Last updated: October 26, 2017
• Start date: October 2007
• Est. completion date: October 2008

Study information

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

Clinical Trial Summary

This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for evaluation and injection were enrolled.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.

• Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.

• Were naïve to AA4500 treatment or had received one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-855.

• Were judged to be in good health.

Exclusion Criteria:

• Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.

• Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.

• Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.

Related Conditions & MeSH terms

• Advanced Dupuytren's Disease
• Dupuytren Contracture

Intervention

Biological:
• collagenase clostridium histolyticum
Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.

Locations

Country	Name	City	State
United States	St. Alexius Medical Center	Bismarck	North Dakota
United States	Providence Clinical Research	Burbank	California
United States	Alpha Clinical Research	Clarksville	Tennessee
United States	Southern Illinois Hand Center, S.C.	Effingham	Illinois
United States	Hamot Center for Clinical Research	Erie	Pennsylvania
United States	Accurate Clincal Research	Houston	Texas
United States	The Rheumatic Disease Clinic of Houston	Houston	Texas
United States	The Indiana Hand Center	Indianapolis	Indiana
United States	David R. Mandel, Inc.	Mayfield	Ohio
United States	Hope Research Institute	Phoenix	Arizona
United States	St. Vincent Medical Center	Portland	Oregon
United States	Rockford Orthopedic Associates, Ltd.	Rockford	Illinois
United States	Tucson Orthopedic Institute, P.C.	Tucson	Arizona
United States	Pri Via	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Contracture to 5° or Less	The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection	Within 30 days after the last injection
Secondary	Clinical Improvement After the Last Injection	Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection.	Baseline; within 30 days after last injection
Secondary	Percent Reduction From Baseline Contracture After the Last Injection	Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture)	Baseline, within 30 days after last injection
Secondary	Change From Baseline Range of Motion After the Last Injection	Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.	Baseline, 30 days after last injection
Secondary	Time to Reach Clinical Success	Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories.	First evaluation visit on which clinical success is achieved through the Day 30 evaluation
Secondary	Clinical Success After the First Injection	Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.	Within 30 days after first injection
Secondary	Clinical Improvement After the First Injection	Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection	Baseline; within 30 days after first injection
Secondary	Percent Reduction From Baseline Contracture After the First Injection	Percent change in degree of contracture is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture.	Baseline; within 30 days after first injection
Secondary	Change From Baseline Range of Motion After the First Injection	Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion.	Baseline; within 30 days after first injection

External Links

•   XIAFLEX Medication Guide
•   XIAFLEX Prescribing Information