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Completed

NCT Number: NCT00954746

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

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.

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Key information

Conditions

Dupuytren's Disease Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Nervous System Diseases Neuromuscular Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal North Shore Hospital, St Leonards, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Contracture Measurements

    Time frame: yearly

Secondary outcomes

  1. Immunogenicity, concomitant medications, medical history, and adverse events

    Time frame: yearly

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 7, 2009
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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