Clinical trial NCT00954746: Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
Official title: CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dupuytren's Disease
Keywords: Advanced Dupuytren's Disease
Muscular Diseases
Musculoskeletal Diseases
Contracture Joint Diseases
Connective Tissue Diseases
Dupuytren's Contracture
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-08-07
Enrollment: 645
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Advanced Dupuytren's Disease Previously Treated with AA4500 in Studies AUX-CC-854, AUX-CC-856, AUX-CC-857/AUX-CC-858, and AUX-CC-859

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.

Eligibility criteria: 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

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