Trial Information

Summary: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance 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 in subjects who have participated in NCT00488774 or NCT00487539. 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

Approximately 1350 subjects will participate in the study at approximately 300 centers. Following participation in one of the previous 6-week induction studies (NCT00488774 or NCT00487539), subjects will be eligible to participate in this maintenance study that will last up to 54 weeks. Subjects will receive multiple subcutaneous (under the skin) injections of placebo or golimumab every 4 weeks through Week 52. On completing this study, subjects will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years.

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 received all study agent administrations and completed the Week 6 Mayo score evaluation in one of the induction studies of CNTO 148 (golimumab) for (UC) Ulcerative Colitis (CR014176, CR014188)

    • In addition, you can not:

    • have started or increased the dose of concomitant ulcerative colitis medications since Week 0 of an induction study (CR014176, CR014188)

    If you are interested in participating in this study and would like more information, please contact http://clinicaltrials.gov/ct and reference NCT00488631.

    Contact:

    Nahla Hasabou, Primary Study Coordinator
    Evanston Northwestern Healthcare
    2100 Pfingsten Road, B230
    Glenview, IL 60026
    Telephone: 847- 832-6212
    Fax: 847- 657-1961
    Email:

    Profile Page: Evanston Northwestern Healthcare, Glenview, IL

    If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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    Trial listings updated: June 1, 2008 at 6:42:47 AM


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