Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease (JOINT-I)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00528840|
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : October 22, 2010
Last Update Posted : December 2, 2017
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 or disease||Intervention/treatment||Phase|
|Advanced Dupuytren's Disease||Biological: collagenase clostridium histolyticum||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
|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.
- Reduction in Contracture to 5° or Less [ Time Frame: Within 30 days after the last injection ]The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection
- Clinical Improvement After the Last Injection [ Time Frame: Baseline; within 30 days after last injection ]Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection.
- Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: Baseline, within 30 days after last injection ]Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture)
- Change From Baseline Range of Motion After the Last Injection [ Time Frame: Baseline, 30 days after last injection ]Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.
- Time to Reach Clinical Success [ Time Frame: First evaluation visit on which clinical success is achieved through the Day 30 evaluation ]Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories.
- Clinical Success After the First Injection [ Time Frame: Within 30 days after first injection ]Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.
- Clinical Improvement After the First Injection [ Time Frame: Baseline; within 30 days after first injection ]Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection
- Percent Reduction From Baseline Contracture After the First Injection [ Time Frame: Baseline; within 30 days after first injection ]Percent change in degree of contracture is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture.
- Change From Baseline Range of Motion After the First Injection [ Time Frame: Baseline; within 30 days after first injection ]Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528840
|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|
|Wichita, Kansas, United States, 67214|
|United States, North Dakota|
|St. Alexius Medical Center|
|Bismarck, North Dakota, United States, 58501|
|United States, Ohio|
|David R. Mandel, Inc.|
|Mayfield, 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|
|Study Director:||Veronica Urdaneta, MD||Endo Pharmaceuticals|