AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture - Full Text View

Sponsored by:	Auxilium Pharmaceuticals
Information provided by:	Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00528424

Purpose

Study AUX-CC-858 is an open-label continuation of the double-blind Study AUX-CC-857. Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 will enter into Study AUX-CC-858. Subjects who require further treatment in Study AUX-CC-858 either because their treated joint was not a clinical success (primary joint received placebo or another joint received less than 3 injections) or they have other affected joints that were not treated will have the option to receive up to 5 injections of AA4500 in this extension study. Subjects will have follow-up visits through Month 9.

Condition	Intervention	Phase
Dupuytren's Contracture	Biological: Clostridial Collagenase for Injection (AA4500)	Phase III

Drug Information available for: Collagenase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture

Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:

Clinical success of each treated joint [ Time Frame: Within 30 days after the last injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical improvement of each treated joint. [ Time Frame: within 30 days after the last injection ] [ Designated as safety issue: No ]
Percent reduction from baseline in contracture of each treated joint. [ Time Frame: within 30 days after the last injection ] [ Designated as safety issue: No ]
Percent change from baseline in range of motion of each treated joint. [ Time Frame: within 30 days after the last injection ] [ Designated as safety issue: No ]
Time to clinical success of each treated joint. [ Time Frame: within 30 days after the last injection ] [ Designated as safety issue: No ]
Proportion of joints with recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	307
Study Start Date:	December 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Clostridial Collagenase for Injection (AA4500)	Biological: Clostridial Collagenase for Injection (AA4500) Up to 5 injections of AA4500 into the cords of the affected hand. Each injection separated by at least 30 days. Individual cords may receive up to a maximum of 3 AA4500 injections.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Dupuytren's contracture with a fixed flexion deformity of at least one finger, other than the thumb, that is at least 20° or no greater than 100° for MP (80° for PIP) contracture, caused by a palpable cord that has never been treated with AA4500.
Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Judged to be in good health.
Must have participated in protocol AUX-CC-857.

Exclusion Criteria:

A chronic muscular, neurological, or neuromuscular disorder that affects the hands.
Received a treatment for Dupuytren's contracture including surgery (fascietomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
A known recent history of stroke, bleeding, a disease process that affects the hands, or other medical condition which in the investigator's opinion would make the subject unsuitable for enrollment in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528424

Locations

United States, California
Hand Surgery Clinic
Palo Alto, California, United States, 94304
UCLA, David Geffen School of Medicine
Los Angeles, California, United States, 90095
United States, Colorado
Hand Surgery Associates, PC
Denver, Colorado, United States, 80210
United States, Georgia
The Hand and Upper Extremity Center of Georgia, P.C.
Atlanta, Georgia, United States, 30342
United States, Illinois
Rockford Orthopedic Associates, Ltd.
Rockford, Illinois, United States, 61107
United States, Indiana
The Indiana Hand Center
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Brigham and Women's Hospital, Department of Orthopedic Surgery
Boston, Massachusetts, United States, 02115
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
United States, Minnesota
TRIA Orthopaedic Center
Minneapolis, Minnesota, United States, 55431
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
SUNY Stony Brook - Department of Orthopedics
Stony Brook, New York, United States, 11794
United States, Oklahoma
Health Research Institute
Oklahoma city, Oklahoma, United States, 73109
United States, Pennsylvania
Hand Microsurgery & Reconstructive Orthopaedics
Erie, Pennsylvania, United States, 16550
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Rhode Island
Department of Orthopaedics, Brown University, Rhode Island Hospital
Providence, Rhode Island, United States, 02905

Sponsors and Collaborators

Auxilium Pharmaceuticals

Investigators

Study Director:

John Rodzvilla, MD

Auxilium Pharmaceuticals, Inc.

More Information

Responsible Party:	Auxilium Pharmaceuticals, Inc. ( John Rodzilla/ Vice President, Medical Development )
Study ID Numbers:	AUX-CC-858
Study First Received:	September 11, 2007
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00528424
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Muscular Diseases
Musculoskeletal Diseases
Contracture
Joint Diseases

Connective Tissue Diseases
Dupuytren's Contracture
Dupuytren's contracture

ClinicalTrials.gov processed this record on January 15, 2009