Clinical trial NCT00528424: AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Official title: A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Dupuytren's Disease
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Reduction in Contracture to 5° or Less
timeFrame: Within 30 days after last injection
Secondary outcomes:
measure: Clinical Improvement After the Last Injection
timeFrame: Baseline, within 30 days after last injection
measure: Percent Reduction From Baseline Contracture After the Last Injection
timeFrame: Baseline, Day 30 after last injection
measure: Change From Baseline Range of Motion After the Last Injection
timeFrame: Baseline, Day 30 after last injection
measure: Time to Reach Clinical Success
timeFrame: Within 30 days after last injection
measure: Clinical Success After the First Injection
timeFrame: Within 30 days after first injection
measure: Clinical Improvement After the First Injection
timeFrame: Baseline, within 30 days after first injection
measure: Percent Reduction From Baseline Contracture After the First Injection
timeFrame: Baseline, Day 30 after first injection
measure: Change From Baseline Range of Motion After the First Injection
timeFrame: Baseline, Day 30 after first injection
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 100 UCLA Medical Plaza, Suite 305
state: California
city: Palo Alto
country: United States
facility: Hand Surgery Clinic
state: California
city: Denver
country: United States
facility: Hand Surgery Associates, PC
state: Colorado
city: Atlanta
country: United States
facility: The Hand and Upper Extremity Center of Georgia, P.C.
state: Georgia
city: Rockford
country: United States
facility: Rockford Orthopedic Associates, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: The Indiana Hand Center
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital, Department of Orthopedic Surgery
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook - Department of Orthopedics
state: New York
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Erie
country: United States
facility: Hand Microsurgery & Reconstructive Orthopaedics
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Providence
country: United States
facility: Department of Orthopaedics, Brown University, Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Endo Pharmaceuticals
name: Veronica Urdaneta, MD
role: STUDY_DIRECTOR
References: