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

Endo Pharmaceuticals201 enrolled

Overview

This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for evaluation and injection were enrolled. 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

201

Conditions

Advanced Dupuytren's Disease

Interventions

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 one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-855. * Were judged to be in good health. 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 (14)

Hope Research Institute

Phoenix, Arizona, United States

Tucson Orthopedic Institute, P.C.

Tucson, Arizona, United States

Providence Clinical Research

Burbank, California, United States

Southern Illinois Hand Center, S.C.

Effingham, Illinois, United States

Rockford Orthopedic Associates, Ltd.

Rockford, Illinois, United States

The Indiana Hand Center

Indianapolis, Indiana, United States

Pri Via

Wichita, Kansas, United States

St. Alexius Medical Center

Bismarck, North Dakota, United States

David R. Mandel, Inc.

Mayfield, Ohio, United States

St. Vincent Medical Center

Portland, Oregon, United States

...and 4 more locations

Outcomes

Primary Outcomes

Reduction in Contracture to 5° or Less

The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection

Time frame: Within 30 days after the last injection

Secondary Outcomes

Clinical Improvement After the Last Injection

Clinical Improvement is defined as \>=50% percent reduction from baseline in 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 measured as 100\*(baseline contracture -last available post-injection contracture)/baseline contracture)

Time frame: Baseline, within 30 days after last injection

Change From Baseline Range of Motion After the Last Injection

Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.

Time frame: Baseline, 30 days after last injection

Time to Reach Clinical Success

Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories.

Time frame: First evaluation visit on which clinical success is achieved through the Day 30 evaluation

Clinical Success After the First Injection

Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.

Time frame: Within 30 days after first injection

Clinical Improvement After the First Injection

Clinical Improvement is defined as \>=50% reduction from baseline in the degree of contracture within 30 days after the first injection

Time frame: Baseline; within 30 days after first injection

Percent Reduction From Baseline Contracture After the First Injection

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

Time frame: Baseline; within 30 days after first injection

Change From Baseline Range of Motion After the First Injection

Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion.

Time frame: Baseline; within 30 days after first injection