Advanced Dupuytren's DiseasePhase 3NCT00528424
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
A Phase 3 study testing AA4500 in people with Advanced Dupuytren's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 15 sites in United States.
Trial summary
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Dupuytren's Disease
- What is being tested?
- AA4500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 15 sitesUnited States
- Study dates
- Dec 2007to Nov 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
- Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- Were naïve to AA4500 treatment or had received only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
- Were judged to be in good health.
- Must have participated in protocol AUX-CC-857 (NCT00528606).
Who cannot join
- Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
- Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
The Hand and Upper Extremity Center of Georgia, P.C.
Atlanta, Georgia, 30342
Brigham and Women's Hospital, Department of Orthopedic Surgery
Boston, Massachusetts, 02115
Hand Surgery Associates, PC
Denver, Colorado, 80210
Hand Microsurgery & Reconstructive Orthopaedics
Erie, Pennsylvania, 16550
The Indiana Hand Center
Indianapolis, Indiana, 46260
100 UCLA Medical Plaza, Suite 305
Los Angeles, California, 90095
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
Department of Orthopaedics, Brown University, Rhode Island Hospital
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
About this study
Official title: A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.
- Conditions
- Advanced Dupuytren's Disease
- Being tested
- AA4500
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AA4500Biological
Also called XIAFLEX®
Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may have received up to a maximum of three AA4500 injections.
| Study group | Role | What they receive |
|---|---|---|
| AA4500 0.58 mg | Experimental | Not described Receives: Biological: AA4500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Contracture to 5° or Less
Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Measured: Within 30 days after last injection
Secondary outcomes (8)
Clinical Improvement After the Last Injection
Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Measured: Baseline, within 30 days after last injection
Percent Reduction From Baseline Contracture After the Last Injection
Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
Measured: Baseline, Day 30 after last injection
Change From Baseline Range of Motion After the Last Injection
Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
Measured: Baseline, Day 30 after last injection
Time to Reach Clinical Success
Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories
Measured: Within 30 days after last injection
Clinical Success After the First Injection
Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Measured: Within 30 days after first injection
Clinical Improvement After the First Injection
Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Measured: Baseline, within 30 days after first injection
Percent Reduction From Baseline Contracture After the First Injection
Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
Measured: Baseline, Day 30 after first injection
Change From Baseline Range of Motion After the First Injection
Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
Measured: Baseline, Day 30 after first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startDec 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 286 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 USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528424
- Sponsor's protocol ID
- AUX-CC-858
- Status last verified
- Oct 2017
- First submitted
- 11 Sep 2007
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
- ClinicalTrials.gov ID
- NCT00528424
- Acronym / sponsor ID
- AUX-CC-858
- Conditions
- Advanced Dupuytren's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2007 (actual)
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Sep 2007 (estimated)
- Results
- Posted 22 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AA4500 0.58 mg | Experimental | Biological: AA4500 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
- Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- Were naïve to AA4500 treatment or had received only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
- Were judged to be in good health.
- Must have participated in protocol AUX-CC-857 (NCT00528606).
Key exclusion criteria (3 listed)
- Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
- Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AA4500Also: XIAFLEX®Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may have received up to a maximum of three AA4500 injections. | Biological | AA4500 0.58 mg |
Primary outcome
Reduction in Contracture to 5° or Less
Time frame: Within 30 days after last injection
Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
8 secondary outcomes
Clinical Improvement After the Last Injection
Time frame: Baseline, within 30 days after last injection
Percent Reduction From Baseline Contracture After the Last Injection
Time frame: Baseline, Day 30 after last injection
Change From Baseline Range of Motion After the Last Injection
Time frame: Baseline, Day 30 after last injection
Time to Reach Clinical Success
Time frame: Within 30 days after last injection
Clinical Success After the First Injection
Time frame: Within 30 days after first injection
Clinical Improvement After the First Injection
Time frame: Baseline, within 30 days after first injection
Percent Reduction From Baseline Contracture After the First Injection
Time frame: Baseline, Day 30 after first injection
Change From Baseline Range of Motion After the First Injection
Time frame: Baseline, Day 30 after first injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- XIAFLEX Prescribing InformationLink provided by the sponsor.
Related trials for Advanced Dupuytren's Disease
RecruitingPhase 2
Nodular Shrinking in Dupuytren Disease
Dupuytren's Disease
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 USA Inc., a Keenova Therapeutics Company
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AA4500 in people with Advanced Dupuytren's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 15 sites in United States.
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 5 inclusion and 3 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in Contracture to 5° or Less (time frame: Within 30 days after last injection). 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 2 Dec 2017.