JPRN-UMIN000010612已完成4 期
A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis - A comparison of the efficacy of tacrolimus with infliximab in ulcerative colitis
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine0 个研究点目标入组 130 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
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
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients with only proctitis. 2. Patients having contraindications to tacrolimus including current use of cyclosporine, bozentan, or potassium-sparing diuretics. 3. Patients having contraindications to infliximab including serious infection (sepsis), active tuberculosis infection, allergy to murine-derive proteins. 4. Patients who have been administered anti-TNF agents, tacrolimus, or cyclosporine. 5. Concomitant medication: 1) Changed the dose of oral 5-aminosalicylate (ASA) agents within 1 week. 2) Used topical 5-ASA agents or topical steroid agents within 1 week. 3) Underwent cytapheresis within 1 week. 4) Started an immunomodulator (azathioprine, mercaptopurine) within 12 weeks or changed the dose of the agent within 4 weeks. 5) Changed the dose of oral prednisolone within 1 week. 6) Changed the dose of intravenous prednisolone within 1 week. 6. Patients who have a serious infection or are suspected to have it. 7. Patients who have a serious cardiovascular disease. 8. Patients who have a serious renal disease (Serum Cr >= 2.0 mg/dl) 9. Patients who have a serious hepatic disease (Total bilirubin >= 3.0 mg/dl or AST or ALT >= 200 IU/ml) 10. Patients who are pregnant, possible to be pregnant, or want to be during the study period, or are breastfeeding. 11. Patients who have a neoplasm or had a neoplasm. 12. Patients who have a psychological disorder. 13. Patients who underwent resection of the colon (excluding appendectomy) 14. Patients who are judged to be exclusive by investigators for a certain reason.
研究者
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