Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859

This study has been completed.
Sponsor:
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
  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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Veronica Urdaneta, MD Endo Health Solutions
  More Information

Additional Information:
No publications provided

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
Connective Tissue Diseases
Contracture
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 01, 2015