Dupuytren's DiseasePhase 4NCT01498640
Retreatment of Recurrent Dupuytren's Contractures
A Phase 4 study testing Collagenase clostridium histolyticum in people with Dupuytren's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 13 sites in 4 countries.
Trial summary
The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease
- What is being tested?
- Collagenase clostridium histolyticum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Mar 2012to Oct 2013
- Phase
- Phase 4
- 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
- Provide written informed consent
- Be currently participating in the AUX-CC-860 follow-up study
- Have at least one joint with all of the following:
- The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
- The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
- A palpable cord is present in the joint to be treated
- Be able to comply with the study visit schedule as specified in the protocol
Who cannot join
- Is a pregnant or lactating female or female intending to become pregnant during the study
- Has hypersensitivity to AA4500 or any of the AA4500 excipients
- Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before injection of AA4500
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States7 sites
Hand Microsurgery and Reconstructive Orthopaedics
Erie, Pennsylvania, 16507
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Marquette General Health System
Marquette, Michigan, 49855
East River Professional Building
New York, New York, 10021
Health Reserarch Institute
Oklahoma City, Oklahoma, 73109
HOPE Research Institute
Phoenix, Arizona, 85050
Rockford Orthopedic Associates
Rockford, Illinois, 61107
Australia3 sites
Peninsula Private Hospital
Kippa-Ring, Queensland, 4021
Emeritus Research
Malvern East, Victoria, 3145
AusTrials Sherwood
Sherwood, Queensland, 4075
United Kingdom2 sites
Pulvertaft Hand Center
Derby, GB, DE22 3NE
Newcastle Upon Tyne Hospitals
Newcastle, GB, NE1 4LP
About this study
Official title: Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe
The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.
Read the detailed description
Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.
Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.
- Conditions
- Dupuytren's Disease
- Being tested
- Collagenase clostridium histolyticum
- Keywords
- XIAFLEX, XIAPEX, Dupuytren's disease, contracture
- Medical subject headings
- Dupuytren Contracture, Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase clostridium histolyticumBiological
Also called XIAFLEX, XIAPEX, AA4500
up to three 0.58 mg injections
| Study group | Role | What they receive |
|---|---|---|
| XIAFLEX/XIAPEX MP Joint | Experimental | Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord Receives: Biological: Collagenase clostridium histolyticum |
| XIAFLEX/XIAPEX PIP Joint | Experimental | Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord Receives: Biological: Collagenase clostridium histolyticum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500
Measured: 30 days after last injection
Percent Change From Baseline in Degree of Contracture
Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Measured: Baseline and 30 days after last injection
Change in Range of Motion
Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
Measured: Baseline and 30 days after last injection
Secondary outcomes (3)
Physician Global Assessment of Improvement
Physician global assessment of change (improvement) in subject's Dupuytren's contracture
Measured: 30 days after last injection
Subject Global Assessment of Satisfaction
Subject global assessment of overall treatment satisfaction
Measured: 30 days after last injection
Recurrence of Contracture
Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
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 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 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, MPPH, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498640
- Sponsor's protocol ID
- AUX-CC-862
- Status last verified
- Sep 2017
- First submitted
- 17 Dec 2011
- Last updated
- 5 Oct 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 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe
- ClinicalTrials.gov ID
- NCT01498640
- Acronym / sponsor ID
- AUX-CC-862
- Conditions
- Dupuytren's Disease
- Keywords
- XIAFLEX, XIAPEX, Dupuytren's disease, contracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Posted 20 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.
Detailed description
Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.
Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XIAFLEX/XIAPEX MP Joint | Experimental | Biological: Collagenase clostridium histolyticumUp to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord |
| XIAFLEX/XIAPEX PIP Joint | Experimental | Biological: Collagenase clostridium histolyticumUp to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written informed consent
- Be currently participating in the AUX-CC-860 follow-up study
- Have at least one joint with all of the following:
- Be able to comply with the study visit schedule as specified in the protocol
Key exclusion criteria (3 listed)
- Is a pregnant or lactating female or female intending to become pregnant during the study
- Has hypersensitivity to AA4500 or any of the AA4500 excipients
- Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before injection of AA4500
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 |
|---|---|---|
| Collagenase clostridium histolyticumAlso: XIAFLEX, XIAPEX, AA4500up to three 0.58 mg injections | Biological | XIAFLEX/XIAPEX MP Joint, XIAFLEX/XIAPEX PIP Joint |
Primary outcome
Clinical Success
Time frame: 30 days after last injection
Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500
Percent Change From Baseline in Degree of Contracture
Time frame: Baseline and 30 days after last injection
Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Change in Range of Motion
Time frame: Baseline and 30 days after last injection
Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
3 secondary outcomes
Physician Global Assessment of Improvement
Time frame: 30 days after last injection
Subject Global Assessment of Satisfaction
Time frame: 30 days after last injection
Recurrence of Contracture
Time frame: Day 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MPPH study director
Endo USA Inc., a Keenova Therapeutics Company
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagenase clostridium histolyticum in people with Dupuytren's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 13 sites in 4 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 7 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, United Kingdom, Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 20 Feb 2015). 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?
Clinical Success (time frame: 30 days after last injection). The study lists 3 primary outcomes in all. 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 5 Oct 2017.