Text Size

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:
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
History of Changes
  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:

Drug Information available for: Collagenase
U.S. FDA Resources

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

  Show 39 Study Locations
Sponsors and Collaborators
Auxilium Pharmaceuticals
Investigators
Study Director: James Tursi, MD Auxilium Pharmaceuticals, Inc
  More Information

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

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 May 19, 2013