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

一项 3 期多中心、随机安慰剂对照、双盲研究

• 批准号: 7952139
• 负责人: JOSEPH H SELLIN
• 金额: $ 0.05万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952139
• 关键词: Adverse event; Blood Tests; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Development; Double-Blind Method; Effectiveness; Evaluation; Feces; Funding; Grant; Inflammation; Injection of therapeutic agent; Institution; Maintenance Therapy; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Pregnancy Tests; Quality of life; Questionnaires; Randomized; Research; Research Personnel; Resources; Safety; Sampling; Sigmoidoscopy; Site; Source; Subcutaneous Injections; Symptoms; Tumor Necrosis Factor-alpha; Tumor Necrosis Factors; Ulcerative Colitis; United States National Institutes of Health; Urine; Weight; diaries; fighting; group intervention; inhibitor/antagonist

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 戈利木单抗是一种肿瘤坏死因子（TNF）抑制剂。肿瘤坏死因子是一种天然存在于体内的物质，这种物质可能会导致长期炎症。 戈利木单抗可能通过阻断体内TNF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。本研究将评估戈利木单抗维持治疗皮下给药在既往参加过研究C 0524 T16的活动性溃疡性结肠炎受试者中的安全性和有效性。 还将评估戈利木单抗皮下给药对溃疡性结肠炎受试者生活质量的影响。受试者将被随机分配至三个干预组之一，并将在第0周和每4周一次接受皮下注射，直至第52周。 可能的干预组如下：第1组：安慰剂，第2组：戈利木单抗50 mg，第3组：戈利木单抗100 mg。将定期进行生命体征、体重、TB评价、乙状结肠镜检查、尿妊娠试验（如适用）、合并用药/不良事件审查、研究药物注射部位评价、日记卡审查、溃疡性结肠炎评估、问卷调查、粪便样本、血液检查。这项研究可能会导致溃疡性结肠炎的新疗法的发展。