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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00528840




Registration number
NCT00528840
Ethics application status
Date submitted
11/09/2007
Date registered
12/09/2007
Date last updated
2/12/2017

Titles & IDs
Public title
Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Scientific title
A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Secondary ID [1] 0 0
AUX-CC-856
Universal Trial Number (UTN)
Trial acronym
JOINT-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Dupuytren's Disease 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - collagenase clostridium histolyticum

Experimental: AA4500 0.58 mg -


Other interventions: collagenase clostridium histolyticum
Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in Contracture to 5° or Less
Timepoint [1] 0 0
Within 30 days after the last injection
Secondary outcome [1] 0 0
Clinical Improvement After the Last Injection
Timepoint [1] 0 0
Baseline; within 30 days after last injection
Secondary outcome [2] 0 0
Percent Reduction From Baseline Contracture After the Last Injection
Timepoint [2] 0 0
Baseline, within 30 days after last injection
Secondary outcome [3] 0 0
Change From Baseline Range of Motion After the Last Injection
Timepoint [3] 0 0
Baseline, 30 days after last injection
Secondary outcome [4] 0 0
Time to Reach Clinical Success
Timepoint [4] 0 0
First evaluation visit on which clinical success is achieved through the Day 30 evaluation
Secondary outcome [5] 0 0
Clinical Success After the First Injection
Timepoint [5] 0 0
Within 30 days after first injection
Secondary outcome [6] 0 0
Clinical Improvement After the First Injection
Timepoint [6] 0 0
Baseline; within 30 days after first injection
Secondary outcome [7] 0 0
Percent Reduction From Baseline Contracture After the First Injection
Timepoint [7] 0 0
Baseline; within 30 days after first injection
Secondary outcome [8] 0 0
Change From Baseline Range of Motion After the First Injection
Timepoint [8] 0 0
Baseline; within 30 days after first injection

Eligibility
Key inclusion criteria
- 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 one or two injections of AA4500 for the
treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853,
or AUX-CC-855.

- Were judged to be in good health.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2008
Sample size
Target
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
North Dakota
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Endo Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a
diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal
interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one
finger, other than the thumb, that was at least 20° as measured by finger goniometry and was
suitable for evaluation and injection were enrolled.

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00528840
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Veronica Urdaneta, MD
Address 0 0
Endo Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries