Dupuytren's contracture MedDRA version: 14.0 Level: PT Classification code 10013872 Term: Dupuytren's contracture System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Collagenase clostridium histolyticum
Product Code: AA4500
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AA4500
Other descriptive name: Collagenase clostrid
Sponsors
Auxilium UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This study is intended to recruit study participants who: Have received at least one injection of AA4500 in one of the previously conducted phase III studies (AUX-CC-854, AUX-CC-856, AUX-CC-857/858 and AUX-CC-859) Are able and willing to comply with the yearly assessments as outlined in the protocol Voluntarily sign and date an informed consent agreement approved by the appropriate Institutional Review Board/Independent Ethics Committee. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: This study is intended to recruit study participants who: Have received at least one injection of AA4500 in one of the previously conducted phase III studies (AUX-CC-854, AUX-CC-856, AUX-CC-857/858 and AUX-CC-859) Are able and willing to comply with the yearly assessments as outlined in the protocol Voluntarily sign and date an informed consent agreement approved by the appropriate Institutional Review Board/Independent Ethics Committee. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: There are no specific exclusion criteria for this study provided that the subject meets all of the inclusion criteria. ;Exclusion criteria: There are no specific exclusion criteria for this study provided that the subject meets all of the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to assess how long the response to a previous treatment of AA4500 will last for (durability of response); to assess the natural progression or recurrence of Dupuytren's disease in subjects previously treated with AA4500 and to assess the long term safety of AA4500.;Secondary Objective: All covered in primary objectives listed above in section A10.;Primary end point(s): The primary outcome measure for the study is the finger goniometry data (fixed and full flexion contracture measurements) and new medical/surgical interventions for Dupuytren's disease which will enable the durability of response in joints with measurable improvement in contracture (>20 degrees) after treatment with AA4500 in one of the previous phase III studies. The goniometry data and new medical/surgical intervention data will also allow the evaluation of the progression of Dupuytren's disease in joints that either were not treated with AA4500 or did not have a measurable improvement in contracture (20 degrees) after treatment with AA4500 in one of the previous phase III studies. The goniometry data and new medical/surgical intervention data will also allow the evaluation of the progression of Dupuytren's disease in joints that either were not treated with AA4500 or did not have a measurable improvement in contracture (<20 degrees) in one of the previous phase III studies. The other primary outcome measure is to assess the long term safety of treatment with AA4500. | — |
Countries
Denmark, Finland, Sweden, United Kingdom
Contacts
Public ContactClinical Research International;Clinical Research International ;
Auxilium Uk Limited;Auxilium Uk Limited
Outcome results
None listed