A PHASE 3 MULTICENTER, RANDOMIZED PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. Golimumab may help fight ulcerative colitis by blocking the activity of TNF in the body and reducing the symptoms of ulcerative colitis. This study will assess the safety and effectiveness of Golimumab maintenance therapy administered subcutaneously in subjects with active ulcerative colitis who have participated in a previous study, C0524T16. The effect of subcutaneously administered Golimumab on the quality of life in subjects with ulcerative colitis will also be assessed. Subjects will be randomized to one of three intervention groups and will receive subcutaneous injections at Week 0 and every 4 weeks through Week 52. The possible intervention groups are as follows: Group 1: Placebo, Group 2: Golimumab 50 mg , Group 3: Golimumab 100mg. Vital signs, weight, TB evaluation, sigmoidoscopy, urine pregnancy test (if applicable), concomitant medication/adverse event review, study medication injection site evaluation, diary card review, ulcerative colitis assessments, questionnaires, stool sample, blood tests will be done periodically. The study may result in the development of a new therapy for ulcerative colitis.