CTRI/2022/08/044613暂停未知
A Prospective PlaceboControlled Randomized ClinicalStudy Of Tofacitinib As AnAdjunct to corticosteroids inAcute Severe Ulcerative Colitis
Dr Ajit Sood0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients with acute severe ulcerative colitis (defined by Truelove
- •Witts Criteria)
- •2. Subject must be at least 18 years of age.
- •3. Subjects who are willing and able to comply with treatment plan,
- •laboratory tests, daily bowel movement diary call, and other study
- •procedures.
- •4. Subjects who are willing to provide a written informed consent.
排除标准
- •1. Presence of indeterminate colitis, microscopic colitis, ischemic
- •colitis, infectious colitis, or clinical findings suggestive of Crohnâ??s
- •2. Subjects displaying clinical signs of fulminant colitis or toxic
- •3. Subjects infected with human immunodeficiency virus (HIV) or
- •hepatitis B or C viruses
- •4. Subjects who have been vaccinated with live or attenuated vaccine
- •within 6 weeks of baseline or scheduled to receive these vaccines
- •during study period or within 6 weeks after last dose of study
- •5. Subjects with malignancies or a history of malignancies, with the
- •exception of adequately treated or excised non-metastatic basal cell
- •or squamous cell cancer of the skin.
- •6. Subjects with current or recent history of severe, progressive, or
- •uncontrolled renal, hepatic, hematological, gastrointestinal,
- •metabolic, endocrine, pulmonary, cardiac, neurological disease.
- •7. Pregnant females
研究者
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