EUCTR2017-004496-31-FR进行中（未招募）1 期
A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6- mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis [UC]) OR required more than 3 courses of corticosteroids in the past year
- •- Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist], inclusive), including a (sigmoidoscopy or colonoscopy) sub
- •score greater than or equal to (>=2)
- •- If receiving parenteral or enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0
- •- No history of latent or active tuberculosis prior to screening
- •- Acceptable evidence of immunity to measles, mumps, rubella, and varicella
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 125
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances
- •- History of malignancy or macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
- •- Have UC limited to the rectum only or to <20 percent (%) of the colon
- •- Presence of a stoma
- •- Presence or history of a fistula
- •- Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (TNF-alpha) therapy per local prescribing information
研究者
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尚未招募
3 期
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