Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study
1 other identifier
observational
645
6 countries
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJune 16, 2015
June 1, 2015
3.8 years
August 6, 2009
June 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contracture Measurements
yearly
Secondary Outcomes (1)
Immunogenicity, concomitant medications, medical history, and adverse events
yearly
Study Arms (1)
Follow-up
Subjects Previously Treated with AA4500
Eligibility Criteria
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
You may qualify if:
- 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)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Hope Research Institute
Phoenix, Arizona, 85050, United States
Tucson Orthopedic Institute, P.C.
Tucson, Arizona, 85172, United States
Providence Clinical Research
Burbank, California, 91505, United States
100 UCLA Medical Plaza, Suite 305
Los Angeles, California, 90024, United States
Hand Surgery Clinic
Palo Alto, California, 94304, United States
The Hand and Upper Extremity Center of Georgia, P.C.
Atlanta, Georgia, 30342, United States
Southern Illinois Hand Center, S.C.
Effingham, Illinois, 62401, United States
Rockford Orthopedic Associates, Ltd.
Rockford, Illinois, 61107, United States
The Indiana Hand Center
Indianapolis, Indiana, 46260, United States
Via Christi Research
Wichita, Kansas, 67214, United States
Brigham and Women's Hospital, Department of Orthopedic Surgery
Boston, Massachusetts, 02115, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Marquette General Health System
Marquette, Michigan, 49855, United States
TRIA Orthopaedic Center
Minneapolis, Minnesota, 55431, United States
Hospital for Special Surgery
New York, New York, 10021, United States
SUNY Stony Brook - Department of Orthopedics
Stony Brook, New York, 11794, United States
The Bone and Joint Center
Bismarck, North Dakota, 58502, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Hand Microsurgery & Reconstructive Orthopedics
Erie, Pennsylvania, 16507, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
University Orthopedics, Inc.
Providence, Rhode Island, 02905, United States
Alpha Clinical Research
Clarksville, Tennessee, 37043, United States
Accurate Clincal Research
Houston, Texas, 77034, United States
Royal North Shore Hospital
St Leonards, New South Wales, NSW 2065, Australia
Rivercity Hospital
Auchenflower, Queensland, QLD4067, Australia
Caboolture Clinical Research Centre
Caboolture, Queensland, QLD4510, Australia
Peninsula Clinical Research
Kippa-Ring, Queensland, QLD 4021, Australia
Menzies Research Institute
Hobart, Tasmania, TAS7000, Australia
Emeritus Research
Malvern, Victoria, VIC 3144, Australia
Gentofte Hospital
Hellerup, Copenhagen, DK-2900, Denmark
Hospital of Aalborg
Aalborg, 9100, Denmark
Rigshospitalet
Copenhagen, DK-2100, Denmark
Dextra
Helsinki, 00305, Finland
Koskiklinikka
Tampere, 33100, Finland
Department of Hand Surgery
Malmo, S-205 02, Sweden
Department of Hand Surgery, Akademiska University Hospital
Uppsala, S-751 85, Sweden
Pulvertaft Hand Clinic
Derby, Derbyshire, DE22 3NE, United Kingdom
Newcastle Biomedicine Clinical Research Facility
Newcastle, Newcastle Upon Tyne, NE1 4LP, United Kingdom
Welsh Centre for Plastic Surgery Morriston Hospital
Swansea, Wales, SA6 6NL, United Kingdom
Related Links
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Veronica Urdaneta, MD
Endo Health Solutions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 7, 2009
Study Start
July 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
June 16, 2015
Record last verified: 2015-06