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

June 12, 2015 updated by: Endo Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

645

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • St Leonards, New South Wales, Australia, NSW 2065
        • Royal North Shore Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, QLD4067
        • Rivercity Hospital
      • Caboolture, Queensland, Australia, QLD4510
        • Caboolture Clinical Research Centre
      • Kippa Ring, Queensland, Australia, QLD 4021
        • Peninsula Clinical Research
    • Tasmania
      • Hobart, Tasmania, Australia, TAS7000
        • Menzies Research Institute
    • Victoria
      • Malvern, Victoria, Australia, VIC 3144
        • Emeritus Research
      • Aalborg, Denmark, 9100
        • Hospital of Aalborg
      • Copenhagen, Denmark, DK-2100
        • Rigshospitalet
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, DK-2900
        • Gentofte Hospital
      • Helsinki, Finland, 00305
        • Dextra
      • Tampere, Finland, 33100
        • Koskiklinikka
      • Malmo, Sweden, S-205 02
        • Department of Hand Surgery
      • Uppsala, Sweden, S-751 85
        • Department of Hand Surgery, Akademiska University Hospital
    • Derbyshire
      • Derby, Derbyshire, United Kingdom, DE22 3NE
        • Pulvertaft Hand Clinic
    • Newcastle Upon Tyne
      • Newcastle, Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Newcastle Biomedicine Clinical Research Facility
    • Wales
      • Swansea, Wales, United Kingdom, SA6 6NL
        • Welsh Centre for Plastic Surgery Morriston Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Hope Research Institute
      • Tucson, Arizona, United States, 85172
        • Tucson Orthopedic Institute, P.C.
    • California
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Los Angeles, California, United States, 90024
        • 100 UCLA Medical Plaza, Suite 305
      • Palo Alto, California, United States, 94304
        • Hand Surgery Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • The Hand and Upper Extremity Center of Georgia, P.C.
    • Illinois
      • Effingham, Illinois, United States, 62401
        • Southern Illinois Hand Center, S.C.
      • Rockford, Illinois, United States, 61107
        • Rockford Orthopedic Associates, Ltd.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • The Indiana Hand Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Via Christi Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital, Department of Orthopedic Surgery
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
    • Michigan
      • Marquette, Michigan, United States, 49855
        • Marquette General Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55431
        • TRIA Orthopaedic Center
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • Stony Brook, New York, United States, 11794
        • SUNY Stony Brook - Department of Orthopedics
    • North Dakota
      • Bismark, North Dakota, United States, 58502
        • The Bone and Joint Center
    • Oklahoma
      • Oklahoma city, Oklahoma, United States, 73109
        • Health Research Institute
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Hand Microsurgery & Reconstructive Orthopedics
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Orthopedics, Inc.
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Alpha Clinical Research
    • Texas
      • Houston, Texas, United States, 77034
        • Accurate Clincal Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Follow-up
Subjects Previously Treated with AA4500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contracture Measurements
Time Frame: yearly
yearly

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity, concomitant medications, medical history, and adverse events
Time Frame: yearly
yearly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Veronica Urdaneta, MD, Endo Health Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 12, 2015

Last Verified

June 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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