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Therapeutic Areas: Gastroenterology
Disease Category: Ulcerative Colitis

Trial Information

A Phase 2/3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Purpose

The purpose of this trial is to determine if treatment with an experimental drug (golimumab) that is subcutaneously (under the skin) administered can safely and effectively reduce the signs and symptoms of active ulcerative colitis (such as diarrhea and rectal bleeding) better than treatment with placebo. A placebo is an inactive or dummy treatment that looks the same as the study drug but does not contain any active medication. Golimumab is not approved for use in ulcerative colitis.

Study Design

About 676 patients will participate in the study at approximately 150 centers. Participation in the study will last for six weeks. Subjects will receive multiple injections (under the skin) of placebo or golimumab. At Week 6, subjects will be asked to participate in an additional 54-week maintenance study (NCT00488631) and a long-term extension study that will last approximately 3 years. If the subject chooses not to participate in the maintenance study, his/her participation in this study will extend 16 weeks after the last dose of study medication.

Eligibility

Men and women, 18 years of age or older

Criteria
If you meet the following criteria (there are other criteria not listed) you may qualify for this study:

• You must have a diagnosis of moderately to severely active ulcerative colitis confirmed by biopsy.
• You must either be currently receiving treatment with, or have a history of having failed to respond to, or tolerate, at least one of the following therapies: oral corticosteroids, 6-mercaptopurine (6MP) and azathioprine (AZA).

In addition, you can not:

• Have severe extensive ulcerative colitis that is likely to require a colectomy within 12 weeks of study entry
• Have ulcerative colitis limited to the rectum only or to <20 cm of the colon
• Have a stoma
• Have a history of a fistula
• Have previous exposure to anti-TNF therapies

If you are interested in participating in this study and would like more information, please contact http://clinicaltrials.gov/ct and reference NCT00487539.

Patti Lewis, Primary Study Coordinator
Southern Gastroenterology Associates
3100 Wellons Blvd.
New Bern NC 28562
Phone: 1 252 6349000
Fax: 1 252 6349001
EMail: fnplewis@yahoo.com

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