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Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease (JOINT-I)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00528840
First Posted: September 12, 2007
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Endo Pharmaceuticals
  Purpose

This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for evaluation and injection were enrolled.

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: collagenase clostridium histolyticum Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Reduction in Contracture to 5° or Less [ Time Frame: Within 30 days after the last injection ]
    The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection


Secondary Outcome Measures:
  • Clinical Improvement After the Last Injection [ Time Frame: Baseline; within 30 days after last injection ]
    Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection.

  • Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: Baseline, within 30 days after last injection ]
    Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture)

  • Change From Baseline Range of Motion After the Last Injection [ Time Frame: Baseline, 30 days after last injection ]
    Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.

  • Time to Reach Clinical Success [ Time Frame: First evaluation visit on which clinical success is achieved through the Day 30 evaluation ]
    Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories.

  • Clinical Success After the First Injection [ Time Frame: Within 30 days after first injection ]
    Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.

  • Clinical Improvement After the First Injection [ Time Frame: Baseline; within 30 days after first injection ]
    Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection

  • Percent Reduction From Baseline Contracture After the First Injection [ Time Frame: Baseline; within 30 days after first injection ]
    Percent change in degree of contracture is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture.

  • Change From Baseline Range of Motion After the First Injection [ Time Frame: Baseline; within 30 days after first injection ]
    Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion.


Enrollment: 201
Actual Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AA4500 0.58 mg Biological: collagenase clostridium histolyticum
Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.
Other Names:
  • XIAFLEX®
  • AA4500

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-855.
  • Were judged to be in good health.

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
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): NCT00528840


Locations
United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85050
Tucson Orthopedic Institute, P.C.
Tucson, Arizona, United States, 85172
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
United States, Illinois
Southern Illinois Hand Center, S.C.
Effingham, Illinois, United States, 62401
Rockford Orthopedic Associates, Ltd.
Rockford, Illinois, United States, 61107
United States, Indiana
The Indiana Hand Center
Indianapolis, Indiana, United States, 46260
United States, Kansas
Pri Via
Wichita, Kansas, United States, 67214
United States, North Dakota
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
David R. Mandel, Inc.
Mayfield, Ohio, United States, 44143
United States, Oregon
St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Hamot Center for Clinical Research
Erie, Pennsylvania, United States, 16550
United States, Tennessee
Alpha Clinical Research
Clarksville, Tennessee, United States, 37043
United States, Texas
The Rheumatic Disease Clinic of Houston
Houston, Texas, United States, 77004
Accurate Clincal Research
Houston, Texas, United States, 77034
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Veronica Urdaneta, MD Endo Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00528840     History of Changes
Other Study ID Numbers: AUX-CC-856
First Submitted: September 11, 2007
First Posted: September 12, 2007
Results First Submitted: September 24, 2010
Results First Posted: October 22, 2010
Last Update Posted: December 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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