Phase 3, Open Label Study of Safety and Efficacy of AA4500 in Subjects With Dupuytren's Contracture - Open Label Study of AA4500 in Subjects with Dupuytren's Contracture

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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