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

Advanced Dupuytren's Disease Clinical Trial

Official title:

A Phase 3, Open-Label Extension 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: NCT00528424
• Other study ID #: AUX-CC-858
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2007
• Last updated: October 26, 2017
• Start date: December 2007
• Est. completion date: November 2008

Study information

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

Clinical Trial Summary

Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.

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: 286
• Est. completion date: November 2008
• Est. primary completion date: November 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 only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).

• Were judged to be in good health.

• Must have participated in protocol AUX-CC-857 (NCT00528606).

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:
• AA4500
Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may have received up to a maximum of three AA4500 injections.

Locations

Country	Name	City	State
United States	The Hand and Upper Extremity Center of Georgia, P.C.	Atlanta	Georgia
United States	Brigham and Women's Hospital, Department of Orthopedic Surgery	Boston	Massachusetts
United States	Hand Surgery Associates, PC	Denver	Colorado
United States	Hand Microsurgery & Reconstructive Orthopaedics	Erie	Pennsylvania
United States	The Indiana Hand Center	Indianapolis	Indiana
United States	100 UCLA Medical Plaza, Suite 305	Los Angeles	California
United States	TRIA Orthopaedic Center	Minneapolis	Minnesota
United States	Hospital for Special Surgery	New York	New York
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Health Research Institute	Oklahoma City	Oklahoma
United States	Hand Surgery Clinic	Palo Alto	California
United States	Department of Orthopaedics, Brown University, Rhode Island Hospital	Providence	Rhode Island
United States	Rockford Orthopedic Associates, Ltd.	Rockford	Illinois
United States	University Orthopedics Center	State College	Pennsylvania
United States	SUNY Stony Brook - Department of Orthopedics	Stony Brook	New York

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	Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.	Within 30 days after last injection
Secondary	Clinical Improvement After the Last Injection	Clinical improvement in non-primary joints defined as =50% reduction from baseline in the 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 in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.	Baseline, Day 30 after last injection
Secondary	Change From Baseline Range of Motion After the Last Injection	Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion	Baseline, Day 30 after last injection
Secondary	Time to Reach Clinical Success	Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories	Within 30 days after last injection
Secondary	Clinical Success After the First Injection	Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.	Within 30 days after first injection
Secondary	Clinical Improvement After the First Injection	Clinical improvement in non-primary joints defined as =50% reduction from baseline in the degree of contracture within 30 days after injection	Baseline, within 30 days after first injection
Secondary	Percent Reduction From Baseline Contracture After the First Injection	Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.	Baseline, Day 30 after first injection
Secondary	Change From Baseline Range of Motion After the First Injection	Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion	Baseline, Day 30 after first injection

External Links

•   XIAFLEX Medication Guide
•   XIAFLEX Prescribing Information