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

NCT ID: NCT00528424

Last Updated: 2017-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-11-30

Brief 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.

Conditions

Advanced Dupuytren's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AA4500 0.58 mg

Group Type: EXPERIMENTAL

AA4500

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

XIAFLEX®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronica Urdaneta, MD

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

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

Countries

United States

Related Links

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf

XIAFLEX Prescribing Information

Other Identifiers

AUX-CC-858

Identifier Type: -

Identifier Source: org_study_id