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

Status:	Completed
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	18 - Any
Updated:	12/3/2017
Start Date:	August 2007
End Date:	April 2008

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture

This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the
United States. Subjects with a diagnosis of Dupuytren's contracture 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 injection were randomized 2:1 to receive AA4500 0.58 mg or
placebo.

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.

Inclusion Criteria:

- Subjects with a diagnosis of Dupuytren's contracture, 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 that had
never been treated with AA4500.

- Had a positive "table top test," defined as the inability to simultaneously place the
affected finger(s) and palm flat against a table top.

- Judged to be in good health.

Exclusion Criteria:

- Had a chronic muscular, neurological, or neuromuscular disorder that affected the
hands.

- Had received a treatment for Dupuytren's contracture, including surgery (fasciectomy
or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil
and/or interferon on the selected primary joint within 90 days before the first dose
of study drug.

- 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.

We found this trial at

sites

Hospital for Special Surgery

535 E 70th St
New York, New York 10021

(212) 606-1000