AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

Endo Pharmaceuticals286 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

286

Conditions

Advanced Dupuytren's Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

100 UCLA Medical Plaza, Suite 305

Los Angeles, California, United States

Hand Surgery Clinic

Palo Alto, California, United States

Hand Surgery Associates, PC

Denver, Colorado, United States

The Hand and Upper Extremity Center of Georgia, P.C.

Atlanta, Georgia, United States

Rockford Orthopedic Associates, Ltd.

Rockford, Illinois, United States

The Indiana Hand Center

Indianapolis, Indiana, United States

Brigham and Women's Hospital, Department of Orthopedic Surgery

Boston, Massachusetts, United States

Newton-Wellesley Hospital

Newton, Massachusetts, United States

TRIA Orthopaedic Center

Minneapolis, Minnesota, United States

Hospital for Special Surgery

New York, New York, United States

...and 5 more locations

Outcomes

Primary Outcomes

Reduction in Contracture to 5° or Less

Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

Time frame: Within 30 days after last injection

Secondary Outcomes

Clinical Improvement After the Last Injection

Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection

Time frame: Baseline, within 30 days after last injection

Percent Reduction From Baseline Contracture After the Last Injection

Percent change in degree of contracture in non-primary joints measured as 100 \* (baseline contracture - last available post-injection contracture)/baseline contracture.

Time frame: Baseline, Day 30 after last injection

Change From Baseline Range of Motion After the Last Injection

Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion

Time frame: Baseline, Day 30 after last injection

Time to Reach Clinical Success

Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories

Time frame: Within 30 days after last injection

Clinical Success After the First Injection

Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

Time frame: Within 30 days after first injection

Clinical Improvement After the First Injection