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Completed

NCT Number: NCT01498640

Retreatment of Recurrent Dupuytren's Contractures

The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.

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Key information

Conditions

Dupuytren's Disease Connective Tissue Diseases Contracture Dupuytren Contracture Fibroma Joint Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peninsula Private Hospital, Kippa-Ring, Queensland, Australia

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About this study

Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.

Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provide written informed consent
  • Be currently participating in the AUX-CC-860 follow-up study
  • Have at least one joint with all of the following:
  • The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
  • The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
  • A palpable cord is present in the joint to be treated
  • Be able to comply with the study visit schedule as specified in the protocol

Exclusion criteria

  • Is a pregnant or lactating female or female intending to become pregnant during the study
  • Has hypersensitivity to AA4500 or any of the AA4500 excipients
  • Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before injection of AA4500

Treatment and study plan

Collagenase Clostridium Histolyticum

Biological

up to three 0.58 mg injections

Other names: XIAFLEX, XIAPEX, AA4500

Primary outcomes

  1. Clinical Success

    Time frame: 30 days after last injection

    Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500

  2. Percent Change From Baseline in Degree of Contracture

    Time frame: Baseline and 30 days after last injection

    Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees

  3. Change in Range of Motion

    Time frame: Baseline and 30 days after last injection

    Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees

Secondary outcomes

  1. Physician Global Assessment of Improvement

    Time frame: 30 days after last injection

    Physician global assessment of change (improvement) in subject's Dupuytren's contracture

  2. Subject Global Assessment of Satisfaction

    Time frame: 30 days after last injection

    Subject global assessment of overall treatment satisfaction

  3. Recurrence of Contracture

    Time frame: Day 365

    Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 23, 2011
Registry last updated
Oct 5, 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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