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

NCT00528424 | Completed Phase 3 Results

• 1 other identifier: AUX-CC-858
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 15

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical Improvement After the Last Injection

  Baseline, within 30 days after last injection

• Percent Reduction From Baseline Contracture After the Last Injection

  Baseline, Day 30 after last injection

• Change From Baseline Range of Motion After the Last Injection

  Baseline, Day 30 after last injection

• Time to Reach Clinical Success

  Within 30 days after last injection

• Clinical Success After the First Injection

  Within 30 days after first injection

Study Arms (1)

AA4500 0.58 mg

EXPERIMENTAL

Biological: AA4500

Interventions

AA4500 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.

Also known as: XIAFLEX®

AA4500 0.58 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (15)

100 UCLA Medical Plaza, Suite 305

Los Angeles, California, 90095, United States

Location

Hand Surgery Clinic

Palo Alto, California, 94304, United States

Location

Hand Surgery Associates, PC

Denver, Colorado, 80210, United States

Location

The Hand and Upper Extremity Center of Georgia, P.C.

Atlanta, Georgia, 30342, United States

Location

Rockford Orthopedic Associates, Ltd.

Rockford, Illinois, 61107, United States

Location

The Indiana Hand Center

Indianapolis, Indiana, 46260, United States

Location

Brigham and Women's Hospital, Department of Orthopedic Surgery

Boston, Massachusetts, 02115, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

TRIA Orthopaedic Center

Minneapolis, Minnesota, 55431, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

SUNY Stony Brook - Department of Orthopedics

Stony Brook, New York, 11794, United States

Location

Health Research Institute

Oklahoma City, Oklahoma, 73109, United States

Location

Hand Microsurgery & Reconstructive Orthopaedics

Erie, Pennsylvania, 16550, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Department of Orthopaedics, Brown University, Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

Related Links

• XIAFLEX Prescribing Information

MeSH Terms

Interventions

Microbial Collagenase

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Veronica Urdaneta, MD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: December 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 2, 2017
• Results First Posted: October 22, 2010

Record last verified: 2017-10

Locations

US (15)