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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 Golimumab是一种肿瘤坏死因子(TNF)抑制剂。肿瘤坏死因子是一种自然存在于体内的物质，这种物质可能会引起长期的炎症。Golimumab可能通过阻断体内肿瘤坏死因子的活性和减轻溃疡性结肠炎的症状来帮助对抗溃疡性结肠炎。这项研究将评估曾参加过C0524T16研究的活动期溃疡性结肠炎患者皮下注射Golimumab维持疗法的安全性和有效性。皮下注射Golimumab对溃疡性结肠炎患者生活质量的影响也将得到评估。受试者将被随机分到三个干预组中的一个，并在0周和52周期间每4周接受一次皮下注射。可能的干预组如下：第1组：安慰剂，第2组：Golimumab 50 mg，第3组：Golimumab 100 mg。定期进行生命体征、体重、结核病评估、乙状结肠镜检查、尿孕试验(如果适用)、伴随用药/不良事件评估、研究用药注射部位评估、日记卡片评估、溃疡性结肠炎评估、问卷调查、粪便样本、血液测试。这项研究可能会导致一种治疗溃疡性结肠炎的新疗法的开发。

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.