Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
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ClinicalTrials.gov Identifier: NCT00954746 |
Recruitment Status :
Completed
First Posted : August 7, 2009
Last Update Posted : June 16, 2015
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Condition or disease |
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Dupuytren's Disease |
Study Type : | Observational |
Actual Enrollment : | 645 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |

Group/Cohort |
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Follow-up
Subjects Previously Treated with AA4500
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- Contracture Measurements [ Time Frame: yearly ]
- Immunogenicity, concomitant medications, medical history, and adverse events [ Time Frame: yearly ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT00954746

Study Director: | Veronica Urdaneta, MD | Endo Health Solutions |
Responsible Party: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00954746 |
Other Study ID Numbers: |
AUX-CC-860 |
First Posted: | August 7, 2009 Key Record Dates |
Last Update Posted: | June 16, 2015 |
Last Verified: | June 2015 |
Advanced Dupuytren's Disease Muscular Diseases Musculoskeletal Diseases |
Contracture Joint Diseases Connective Tissue Diseases Dupuytren's Contracture |
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 |