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

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ClinicalTrials.gov Identifier: NCT00528424
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : October 22, 2010
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

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.


Condition or disease Intervention/treatment Phase
Advanced Dupuytren's Disease Biological: AA4500 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : December 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: XIAFLEX®




Primary Outcome Measures :
  1. Reduction in Contracture to 5° or Less [ Time Frame: Within 30 days after last injection ]
    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.


Secondary Outcome Measures :
  1. Clinical Improvement After the Last Injection [ Time Frame: Baseline, within 30 days after last injection ]
    Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection

  2. Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: Baseline, Day 30 after last injection ]
    Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture.

  3. Change From Baseline Range of Motion After the Last Injection [ Time Frame: Baseline, Day 30 after last injection ]
    Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion − baseline range of motion

  4. Time to Reach Clinical Success [ Time Frame: Within 30 days after last injection ]
    Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories

  5. Clinical Success After the First Injection [ Time Frame: Within 30 days after first injection ]
    Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

  6. Clinical Improvement After the First Injection [ Time Frame: Baseline, within 30 days after first injection ]
    Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection

  7. Percent Reduction From Baseline Contracture After the First Injection [ Time Frame: Baseline, Day 30 after first injection ]
    Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture − last available post-injection contracture)/baseline contracture.

  8. Change From Baseline Range of Motion After the First Injection [ Time Frame: Baseline, Day 30 after first injection ]
    Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion − baseline range of motion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528424


Locations
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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
Endo Pharmaceuticals
Investigators
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Study Director: Veronica Urdaneta, MD Endo Pharmaceuticals

Additional Information:
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00528424     History of Changes
Other Study ID Numbers: AUX-CC-858
First Posted: September 12, 2007    Key Record Dates
Results First Posted: October 22, 2010
Last Update Posted: December 2, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Dupuytren Contracture
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Contracture
Muscular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases