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

Completed · Phase 3

Conditions studied: Advanced Dupuytren's Disease

In brief

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.

Key facts

Study ID

NCT00528424

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

286

Starts

2007-12-01

Expected to finish

2008-11-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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