Phase 3
N=286
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Advanced Dupuytren's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00528424 ↗Enrolled (actual)
286
Serious AEs
3.2%
Results posted
Oct 2010
Primary outcome: Primary: Reduction in Contracture to 5° or Less — 41.9 Percentage of joints
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AA4500 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Contracture to 5° or Less |
41.9 | — |
| SECONDARY Clinical Improvement After the Last Injection |
65.0 | — |
| SECONDARY Percent Reduction From Baseline Contracture After the Last Injection |
60.8 | — |
| SECONDARY Change From Baseline Range of Motion After the Last Injection |
24.0 | — |
| SECONDARY Time to Reach Clinical Success |
12.5; 15.9; 5.9; 0.0; 2.2; 1.3 | — |
| SECONDARY Clinical Success After the First Injection |
34.1 | — |
| SECONDARY Clinical Improvement After the First Injection |
56.3 | — |
| SECONDARY Percent Reduction From Baseline Contracture After the First Injection |
53.9 | — |
| SECONDARY Change From Baseline Range of Motion After the First Injection |
20 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00528424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.