AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Condition: Advanced Dupuytren's Disease
MeSH terms: Dupuytren Contracture
Intervention: AA4500
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 286.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.