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Completed

NCT Number: NCT00528840

Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

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.

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Key information

Conditions

Advanced Dupuytren's Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hope Research Institute, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collagenase Clostridium Histolyticum

Biological

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: XIAFLEX®, AA4500

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease

Acronym: JOINT-I

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2007
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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