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

Dupuytren's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954746
• Other study ID #: AUX-CC-860
• Status: Completed
• Phase: N/A
• First received: August 6, 2009
• Last updated: June 12, 2015
• Start date: July 2009
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationEuropean Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 645
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren's Disease

Locations

Country	Name	City	State
Australia	Rivercity Hospital	Auchenflower	Queensland
Australia	Caboolture Clinical Research Centre	Caboolture	Queensland
Australia	Menzies Research Institute	Hobart	Tasmania
Australia	Peninsula Clinical Research	Kippa Ring	Queensland
Australia	Emeritus Research	Malvern	Victoria
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Denmark	Hospital of Aalborg	Aalborg
Denmark	Rigshospitalet	Copenhagen
Denmark	Gentofte Hospital	Hellerup	Copenhagen
Finland	Dextra	Helsinki
Finland	Koskiklinikka	Tampere
Sweden	Department of Hand Surgery	Malmo
Sweden	Department of Hand Surgery, Akademiska University Hospital	Uppsala
United Kingdom	Pulvertaft Hand Clinic	Derby	Derbyshire
United Kingdom	Newcastle Biomedicine Clinical Research Facility	Newcastle	Newcastle Upon Tyne
United Kingdom	Welsh Centre for Plastic Surgery Morriston Hospital	Swansea	Wales
United States	The Hand and Upper Extremity Center of Georgia, P.C.	Atlanta	Georgia
United States	The Bone and Joint Center	Bismark	North Dakota
United States	Brigham and Women's Hospital, Department of Orthopedic Surgery	Boston	Massachusetts
United States	Providence Clinical Research	Burbank	California
United States	Alpha Clinical Research	Clarksville	Tennessee
United States	Southern Illinois Hand Center, S.C.	Effingham	Illinois
United States	Hand Microsurgery & Reconstructive Orthopedics	Erie	Pennsylvania
United States	Accurate Clincal Research	Houston	Texas
United States	The Indiana Hand Center	Indianapolis	Indiana
United States	100 UCLA Medical Plaza, Suite 305	Los Angeles	California
United States	Marquette General Health System	Marquette	Michigan
United States	TRIA Orthopaedic Center	Minneapolis	Minnesota
United States	Hospital for Special Surgery	New York	New York
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Health Research Institute	Oklahoma city	Oklahoma
United States	Hand Surgery Clinic	Palo Alto	California
United States	Hope Research Institute	Phoenix	Arizona
United States	University Orthopedics, Inc.	Providence	Rhode Island
United States	Rockford Orthopedic Associates, Ltd.	Rockford	Illinois
United States	University Orthopedics Center	State College	Pennsylvania
United States	SUNY Stony Brook - Department of Orthopedics	Stony Brook	New York
United States	Tucson Orthopedic Institute, P.C.	Tucson	Arizona
United States	Via Christi Research	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contracture Measurements		yearly	No
Secondary	Immunogenicity, concomitant medications, medical history, and adverse events		yearly	No

External Links

•   Collagenase
•   Dupuytren Society