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

Endo Pharmaceuticals645 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

645

Conditions

Dupuytren's Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (39)

Outcomes

Primary Outcomes

Contracture Measurements

Time frame: yearly

Secondary Outcomes

Immunogenicity, concomitant medications, medical history, and adverse events

Time frame: yearly

Data from ClinicalTrials.gov

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