Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease (JOINT-I)
This study has been completed.
Sponsor:
Auxilium Pharmaceuticals
Information provided by:
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00528840
First received: September 11, 2007
Last updated: January 18, 2012
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Dupuytren's Disease |
Biological: collagenase clostridium histolyticum |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease |
Resource links provided by NLM:
Further study details as provided by Auxilium Pharmaceuticals:
Primary Outcome Measures:
- Reduction in Contracture to 5° or Less [ Time Frame: Within 30 days after the last injection ] [ Designated as safety issue: No ]The Primary Outcome Measure is the percentage of 292 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
Secondary Outcome Measures:
- Clinical Improvement After the Last Injection [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: No ]
- Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: No ]
- Change From Baseline Range of Motion After the Last Injection [ Time Frame: 30 days after last treatment ] [ Designated as safety issue: No ]
- Time to First Achieve and Maintain Clinical Success After the Last Injection [ Time Frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation ] [ Designated as safety issue: No ]
- Clinical Success After the First Injection [ Time Frame: 30 days after first treatment ] [ Designated as safety issue: No ]
- Clinical Improvement After the First Injection [ Time Frame: 30 days after first treatment ] [ Designated as safety issue: No ]
- Percent Reduction From Baseline Contracture After the First Injection [ Time Frame: 30 days after first treatment ] [ Designated as safety issue: No ]
- Change From Baseline Range of Motion After the First Injection [ Time Frame: 30 days after first treatment ] [ Designated as safety issue: No ]
| Enrollment: | 201 |
| Study Start Date: | October 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AA4500 0.58 mg |
Biological: 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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528840
Locations
| United States, Arizona | |
| Hope Research Institute | |
| Phoenix, Arizona, United States, 85050 | |
| Tucson Orthopedic Institute, P.C. | |
| Tucson, Arizona, United States, 85172 | |
| United States, California | |
| Providence Clinical Research | |
| Burbank, California, United States, 91505 | |
| United States, Illinois | |
| Southern Illinois Hand Center, S.C. | |
| Effingham, Illinois, United States, 62401 | |
| Rockford Orthopedic Associates, Ltd. | |
| Rockford, Illinois, United States, 61107 | |
| United States, Indiana | |
| The Indiana Hand Center | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| Pri Via | |
| Wichita, Kansas, United States, 67214 | |
| United States, North Dakota | |
| St. Alexius Medical Center | |
| Bismark, North Dakota, United States, 58501 | |
| United States, Ohio | |
| David R. Mandel, Inc. | |
| Mayfield Village, Ohio, United States, 44143 | |
| United States, Oregon | |
| St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Hamot Center for Clinical Research | |
| Erie, Pennsylvania, United States, 16550 | |
| United States, Tennessee | |
| Alpha Clinical Research | |
| Clarksville, Tennessee, United States, 37043 | |
| United States, Texas | |
| The Rheumatic Disease Clinic of Houston | |
| Houston, Texas, United States, 77004 | |
| Accurate Clincal Research | |
| Houston, Texas, United States, 77034 | |
Sponsors and Collaborators
Auxilium Pharmaceuticals
Investigators
| Study Director: | John Rodzvilla, MD | Auxilium Pharmaceuticals, Inc |
More Information
Additional Information:
No publications provided
| Responsible Party: | John Rodzvilla/ Vice President, Medical Development, Auxilium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00528840 History of Changes |
| Other Study ID Numbers: | AUX-CC-856 |
| Study First Received: | September 11, 2007 |
| Results First Received: | September 24, 2010 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dupuytren Contracture Contracture Muscular Diseases Musculoskeletal Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 21, 2013