Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00954746
First received: August 6, 2009
Last updated: June 12, 2015
Last verified: June 2015
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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 |
|---|
|
Dupuytren's Disease |
| 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 Endo 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 |
|---|
|
Follow-up
Subjects Previously Treated with AA4500
|
Detailed Description:
Phase 3 non-treatment study in which Year 2 to Year 5 year follow-up of subjects who received AA4500 in the 9-month open-label studies (AUX-CC-854 and AUX-CC-856) or the 12-month double-blind with open-label extension studies (AUX-CC-857/AUX-CC-858 and AUX-CC-859). After completion of one of the above mentioned studies, subjects are enrolled and followed once a calendar year for 4 consecutive years with at least 6 months between consecutive visits.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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:
Contacts and Locations
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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
Show 39 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954746
Show 39 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
| Study Director: | Veronica Urdaneta, MD | Endo Health Solutions |
More Information
Additional Information:
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00954746 History of Changes |
| Other Study ID Numbers: | AUX-CC-860 |
| Study First Received: | August 6, 2009 |
| Last Updated: | June 12, 2015 |
| 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 Endo 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 September 30, 2016