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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study|
- Contracture Measurements [ Time Frame: yearly ] [ Designated as safety issue: No ]
- Immunogenicity, concomitant medications, medical history, and adverse events [ Time Frame: yearly ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||July 2009|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Subjects Previously Treated with AA4500
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954746
Show 39 Study Locations
|Study Director:||Veronica Urdaneta, MD||Endo Health Solutions|