Dupuytren's Contracture MedDRA version: 8.1 Level: LLT Classification code 10013872 Term: Dupuytren's contracture
Conditions
Interventions
Product Name: Clostridial Collagenase for Injection
Product Code: AA4500
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AA4500
Other descriptive name: Clostridial Collage
Sponsors
Auxilium UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to enter the study: 1. Subject is at least 18 years of age. 2. Subjects must have a diagnosis of Dupuytren’s contracture with a fixed-flexion (ie, = 20º but = 80º for PIP joint; = 20º but = 100º for MP joint) deformity of at least one finger, other than the thumb, that is caused by a palpable cord. 3. Subject must have a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. 4. Subject is naïve to AA4500 treatment or has received one or two injections of AA4500 for the treatment of Dupuytren’s contracture in Auxilium studies AUX CC 851, AUX-CC-853, or AUX-CC-855. 5. Subject is judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile. 6. Subject voluntarily signs and dates an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). 7. Female subjects of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (ie, no menses for at least 1 year). A pregnancy test will be performed prior to enrollment in the study. 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: Subjects will be excluded from study participation for the following reasons: 1. Female subjects who are nursing or pregnant, or plan to become pregnant during the treatment phase. 2. Subject has a chronic muscular, neurological, or neuromuscular disorder that affects the hands. 3. Subject has received an investigational drug within 30 days prior to the first dose of study drug. 4. Subject has received treatment for Dupuytren’s contracture within 90 days of enrollment on the joint selected for the initial injection of AA4500. Treatment for Dupuytren’s contracture include surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon. 5. Subject has a known allergy to collagenase or any other excipient of AA4500. 6. Subject has received doxycycline or doxycycline derivative during the 14 days prior to the first dose of study drug. 7. Subject has received any collagenase treatments within 30 days. 8. Subject is receiving anticoagulant medication or has received anticoagulant medication (except for aspirin = 150 mg daily) within 7 days before the first injection. 9. Subject has a known recent history of stroke, bleeding, a disease process that affects the hands, or other medical condition which in the investigator’s opinion would make the subject unsuitable for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Additional secondary objectives of the trial include clinical improvement (defined as 50% reduction in contracture); percentage reduction in contracture from baseline; percent improvement in range of motion of the affected finger(s) from baseline; time to reach clinical success or clinical improvement following last injection. ;Main Objective: The main objective of the study is to evaluate the safety and efficacy of up to five injections of AA4500 0.58mg (maximum three injections per joint) in reducing the degree of contracture (fixed flexion deformity) in joints of subjects with Dupuytren's Contracture. Clinical success of the treatment will be defined as a reduction in the joint contracture to 0 - 5 degrees of normal measured by digital goniometry. ;Primary end point(s): The efficacy endpoint is the reduction in contracture (flexion deformity) of each treated joint. A clinical success is defined as a reduction in contracture to within 0° 5° of normal measured by digital goniometry at the visit 30 days after the injection for each treated joint. If the Day 30 visit is missing, the last evaluation (LOCF) completed post-injection (Day 1 or Day 7) will be used to determine clinical success. | — |
Countries
Denmark, Finland, Sweden, United Kingdom
Outcome results
None listed