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Completed

NCT Number: NCT00528424

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

Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.

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

100 UCLA Medical Plaza, Suite 305, Los Angeles, California, United States

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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 only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
  • Were judged to be in good health.
  • Must have participated in protocol AUX-CC-857 (NCT00528606).

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

AA4500

Biological

Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days. Individual cords may have received up to a maximum of three AA4500 injections.

Other names: XIAFLEX®

Primary outcomes

  1. Reduction in Contracture to 5° or Less

    Time frame: Within 30 days after last injection

    Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° 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 in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection

  2. Percent Reduction From Baseline Contracture After the Last Injection

    Time frame: Baseline, Day 30 after last injection

    Percent change in degree of contracture in non-primary joints 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, Day 30 after last injection

    Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion

  4. Time to Reach Clinical Success

    Time frame: Within 30 days after last injection

    Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories

  5. Clinical Success After the First Injection

    Time frame: Within 30 days after first injection

    Clinical success in non-primary joints defined as reduction in contracture to within 0-5° 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 in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection

  7. Percent Reduction From Baseline Contracture After the First Injection

    Time frame: Baseline, Day 30 after first injection

    Percent change in degree of contracture in non-primary joints 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, Day 30 after first injection

    Change in degree of range of motion in non-primary joints 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 Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease

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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