Dupuytren's DiseaseNCT00954746
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
An observational study of Dupuytren's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 39 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease
- How many people
- 645 participants
- Where
- 39 sitesin 6 countries
- Study dates
- Jul 2009to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
39 sites in 6 countries.
39 sites in 6 countries
United States23 sites
The Hand and Upper Extremity Center of Georgia, P.C.
Atlanta, Georgia, 30342
The Bone and Joint Center
Bismarck, North Dakota, 58502
Brigham and Women's Hospital, Department of Orthopedic Surgery
Boston, Massachusetts, 02115
Providence Clinical Research
Burbank, California, 91505
Alpha Clinical Research
Clarksville, Tennessee, 37043
Southern Illinois Hand Center, S.C.
Effingham, Illinois, 62401
Hand Microsurgery & Reconstructive Orthopedics
Erie, Pennsylvania, 16507
Accurate Clincal Research
Houston, Texas, 77034
The Indiana Hand Center
Indianapolis, Indiana, 46260
100 UCLA Medical Plaza, Suite 305
Los Angeles, California, 90024
Marquette General Health System
Marquette, Michigan, 49855
TRIA Orthopaedic Center
Minneapolis, Minnesota, 55431
Hospital for Special Surgery
New York, New York, 10021
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Health Research Institute
Oklahoma City, Oklahoma, 73109
Hand Surgery Clinic
Palo Alto, California, 94304
Hope Research Institute
Phoenix, Arizona, 85050
University Orthopedics, Inc.
Providence, Rhode Island, 02905
Rockford Orthopedic Associates, Ltd.
Rockford, Illinois, 61107
University Orthopedics Center
State College, Pennsylvania, 16801
SUNY Stony Brook - Department of Orthopedics
Stony Brook, New York, 11794
Tucson Orthopedic Institute, P.C.
Tucson, Arizona, 85172
Via Christi Research
Wichita, Kansas, 67214
Australia6 sites
Rivercity Hospital
Auchenflower, Queensland, QLD4067
Caboolture Clinical Research Centre
Caboolture, Queensland, QLD4510
Menzies Research Institute
Hobart, Tasmania, TAS7000
Peninsula Clinical Research
Kippa-Ring, Queensland, QLD 4021
Emeritus Research
Malvern, Victoria, VIC 3144
Royal North Shore Hospital
St Leonards, New South Wales, NSW 2065
Denmark3 sites
Hospital of Aalborg
Aalborg, 9100
Rigshospitalet
Copenhagen, DK-2100
Gentofte Hospital
Hellerup, Copenhagen, DK-2900
United Kingdom3 sites
Pulvertaft Hand Clinic
Derby, Derbyshire, DE22 3NE
Newcastle Biomedicine Clinical Research Facility
Newcastle, Newcastle Upon Tyne, NE1 4LP
Welsh Centre for Plastic Surgery Morriston Hospital
Swansea, Wales, SA6 6NL
Sweden2 sites
Department of Hand Surgery
Malmö, S-205 02
Department of Hand Surgery, Akademiska University Hospital
Uppsala, S-751 85
About this study
Official title: 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.
Read the 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.
- Conditions
- Dupuytren's Disease
- Keywords
- Advanced Dupuytren's Disease, Muscular Diseases, Musculoskeletal Diseases, Contracture Joint Diseases, Connective Tissue Diseases, Dupuytren's Contracture
- Medical subject headings
- Dupuytren Contracture, Muscular Diseases, Musculoskeletal Diseases, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up | Subjects Previously Treated with AA4500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contracture Measurements
Measured: yearly
Secondary outcomes (1)
Immunogenicity, concomitant medications, medical history, and adverse events
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Urdaneta, MD, Study director, Endo Health Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954746
- Sponsor's protocol ID
- AUX-CC-860
- Status last verified
- Jun 2015
- First submitted
- 6 Aug 2009
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study
- ClinicalTrials.gov ID
- NCT00954746
- Acronym / sponsor ID
- AUX-CC-860
- Conditions
- Dupuytren's Disease
- Keywords
- Advanced Dupuytren's Disease, Muscular Diseases, Musculoskeletal Diseases, Contracture Joint Diseases, Connective Tissue Diseases, Dupuytren's Contracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up | – | –Subjects Previously Treated with AA4500 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Contracture Measurements
Time frame: yearly
1 secondary outcome
Immunogenicity, concomitant medications, medical history, and adverse events
Time frame: yearly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2015.
- CollagenaseLink provided by the sponsor.
- Dupuytren SocietyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Urdaneta, MD study director
Endo Health Solutions
39 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 39 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Australia, Denmark, United Kingdom, Finland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contracture Measurements (time frame: yearly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.