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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00954746

Enrollment

645

Registered

2009-08-07

Start date

2009-07-31

Completion date

2013-05-31

Last updated

2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dupuytren's Disease

Keywords

Advanced Dupuytren's Disease, Muscular Diseases, Musculoskeletal Diseases, Contracture Joint Diseases, Connective Tissue Diseases, Dupuytren's Contracture

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Contracture Measurements	yearly

Secondary

Measure	Time frame
Immunogenicity, concomitant medications, medical history, and adverse events	yearly

Countries

Australia, Denmark, Finland, Sweden, United Kingdom, United States

Outcome results