Santarus Completes Patient Enrollment in CONTRIBUTE Study with UCERIS (budesonide)
Santarus Completes Patient Enrollment in CONTRIBUTE Study with UCERIS (budesonide) as Add-on Treatment to 5-ASA Drugs
Santarus, Inc. (SNTS) today announced the completion of enrollment in the CONTRIBUTE clinical study designed to evaluate the incremental benefit of adding UCERIS® (budesonide) extended release 9 mg tablets to oral aminosalicylate (5-ASA) therapy for the induction of clinical remission in adult patients with active, mild to moderate ulcerative colitis. UCERIS is currently approved in the U.S. for the induction of remission in patients with active, mild to moderate ulcerative colitis.
A total of 509 patients were enrolled in the CONTRIBUTE study, a multicenter, randomized, double-blind, placebo controlled clinical trial. The primary endpoint of the study is clinical remission, defined as a score of 0 for both rectal bleeding and stool frequency on the Ulcerative Colitis Disease Activity Index (UCDAI) scale. All patients were randomized to either the UCERIS or placebo arm and will continue their existing background 5-ASA regimen during the 8 week study.
“We believe the data from this combination study will provide valuable information for physicians who treat patients with active ulcerative colitis,” said Wendell Wierenga, Ph.D., executive vice president of research and development. “We expect to have top-line data from the study available by year-end, and plan to release expanded study results at an appropriate medical meeting in 2014.”
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