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

Purpose

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.

Condition	Intervention	Phase
Advanced Dupuytren's Disease	Biological: AA4500	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:

Reduction in Contracture to 5° or Less [ Time Frame: Within 30 days after the last injection ] [ Designated as safety issue: No ]
The Primary Outcome Measure is the percentage of 320 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.

Secondary Outcome Measures:

Clinical Improvement After the Last Injection [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: No ]
Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: No ]
Change From Baseline Range of Motion After the Last Injection [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: No ]
Time to First Achieve and Maintain Clinical Success After the Last Injection [ Time Frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation ] [ Designated as safety issue: No ]
Clinical Success After the First Injection [ Time Frame: 30 days after first treatment ] [ Designated as safety issue: No ]
Clinical Improvement After the First Injection [ Time Frame: 30 days after first treatment ] [ Designated as safety issue: No ]
Percent Reduction From Baseline Contracture After the First Injection [ Time Frame: 30 days after first treatment ] [ Designated as safety issue: No ]
Change From Baseline Range of Motion After the First Injection [ Time Frame: 30 days after first treatment ] [ Designated as safety issue: No ]

Enrollment:	286
Study Start Date:	December 2007
Study Completion Date:	May 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AA4500 0.58 mg	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. Other Names: XIAFLEX® AA4500

Eligibility

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

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.

Contacts and Locations

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

Locations

United States, California
100 UCLA Medical Plaza, Suite 305
Los Angeles, California, United States, 90095
Hand Surgery Clinic
Palo Alto, California, United States, 94304
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

Additional Information:

XIAFLEX Medication Guide This link exits the ClinicalTrials.gov site

XIAFLEX Prescribing Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00528424 History of Changes
Other Study ID Numbers:	AUX-CC-858
Study First Received:	September 11, 2007
Results First Received:	September 24, 2010
Last Updated:	January 18, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dupuytren Contracture
Contracture
Muscular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013