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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
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Description
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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.

Condition or disease
Dupuytren's Disease

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.

Study Design
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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

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Follow-up
Subjects Previously Treated with AA4500


Outcome Measures
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Primary Outcome Measures :
  1. Contracture Measurements [ Time Frame: yearly ]

Secondary Outcome Measures :
  1. Immunogenicity, concomitant medications, medical history, and adverse events [ Time Frame: yearly ]

Biospecimen Retention:   Samples Without DNA
serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Veronica Urdaneta, MD Endo Health Solutions
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Collagenase  This link exits the ClinicalTrials.gov site
Dupuytren Society  This link exits the ClinicalTrials.gov site

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00954746     History of Changes
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

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
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