Long-term Observational Evaluation of Subjects Treated With AA4500 in Studies AUX-CC-854, AUX-CC-856, AUX-CC-857/AUX-CC-858 and AUX-CC-859

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00954746
First received: August 6, 2009
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500 treatment regimen. This study will also evaluate long-term safety and progression of disease in joints.


Condition Intervention
Dupuytren's Disease
Biological: Collection of immunogenicity samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study

Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:
  • Contracture Measurements [ Time Frame: yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity, concomitant medications, medical history, and adverse events [ Time Frame: yearly ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 645
Study Start Date: July 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Follow-up
Subjects Previously Treated with AA4500
Biological: Collection of immunogenicity samples
no treatment to be administered - observational only
Other Name: AA4500, collagenase clostridium histolyticum

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with Advanced Dupuytren's Disease Previously Treated with AA4500 in Studies AUX-CC-854, AUX-CC-856, AUX-CC-857/AUX-CC-858, and AUX-CC-859

Criteria

Inclusion Criteria:

To be eligible for this study a subject had to:

  • Have received at least one injection of AA4500 in one of the Auxilium sponsored studies (AUX-CC-854, AUX-CC-856, Studies AUX-CC-857/AUX-CC-858, or AUX-CC-859) and have at least one fixed-flexion contracture measurement after treatment with AA4500
  • Be able and willing to comply with the yearly assessments outlined in the protocol, as determined by the investigator
  • Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)

Exclusion Criteria:

  • None
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954746

  Hide Study Locations
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
100 UCLA Medical Plaza, Suite 305
Los Angeles, California, United States, 90024
Hand Surgery Clinic
Palo Alto, California, United States, 94304
United States, Georgia
The Hand and Upper Extremity Center of Georgia, P.C.
Atlanta, Georgia, United States, 30342
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
Via Christi Research
Wichita, Kansas, United States, 67214
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, Michigan
Marquette General Health System
Marquette, Michigan, United States, 49855
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, North Dakota
The Bone and Joint Center
Bismark, North Dakota, United States, 58502
United States, Oklahoma
Health Research Institute
Oklahoma city, Oklahoma, United States, 73109
United States, Pennsylvania
Hand Microsurgery & Reconstructive Orthopedics
Erie, Pennsylvania, United States, 16507
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Rhode Island
University Orthopedics, Inc.
Providence, Rhode Island, United States, 02905
United States, Tennessee
Alpha Clinical Research
Clarksville, Tennessee, United States, 37043
United States, Texas
Accurate Clincal Research
Houston, Texas, United States, 77034
Australia, New South Wales
Royal North Shore Hospital
St Leonards, New South Wales, Australia, NSW 2065
Australia, Queensland
Rivercity Hospital
Auchenflower, Queensland, Australia, QLD4067
Caboolture Clinical Research Centre
Caboolture, Queensland, Australia, QLD4510
Peninsula Clinical Research
Kippa Ring, Queensland, Australia, QLD 4021
Australia, Tasmania
Menzies Research Institute
Hobart, Tasmania, Australia, TAS7000
Australia, Victoria
Emeritus Research
Malvern, Victoria, Australia, VIC 3144
Denmark
Gentofte Hospital
Hellerup, Copenhagen, Denmark, DK-2900
Hospital of Aalborg
Aalborg, Denmark, 9100
Rigshospitalet
Copenhagen, Denmark, DK-2100
Finland
Dextra
Helsinki, Finland, 00305
Koskiklinikka
Tampere, Finland, 33100
Sweden
Department of Hand Surgery
Malmo, Sweden, S-205 02
Department of Hand Surgery, Akademiska University Hospital
Uppsala, Sweden, S-751 85
United Kingdom
Pulvertaft Hand Clinic
Derby, Derbyshire, United Kingdom, DE22 3NE
Newcastle Biomedicine Clinical Research Facility
Newcastle, Newcastle Upon Tyne, United Kingdom, NE1 4LP
Welsh Centre for Plastic Surgery Morriston Hospital
Swansea, Wales, United Kingdom, SA6 6NL
Sponsors and Collaborators
Auxilium Pharmaceuticals
Investigators
Study Director: James Tursi, MD Auxilium Pharmaceuticals, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00954746     History of Changes
Other Study ID Numbers: AUX-CC-860
Study First Received: August 6, 2009
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
European Union: European Medicines Agency

Keywords provided by Auxilium Pharmaceuticals:
Advanced Dupuytren's Disease
Muscular Diseases
Musculoskeletal Diseases
Contracture Joint Diseases
Connective Tissue Diseases
Dupuytren's Contracture

Additional relevant MeSH terms:
Dupuytren Contracture
Connective Tissue Diseases
Contracture
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 22, 2014