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 is ongoing, but not recruiting participants.
Sponsor:
Auxilium Pharmaceuticals
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00954746
First received: August 6, 2009
Last updated: March 19, 2013
Last verified: March 2013
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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 |
Resource links provided by NLM:
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
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954746
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Hide Study LocationsLocations
| 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: | March 19, 2013 |
| 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 Contracture Muscular Diseases Musculoskeletal Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on June 18, 2013