JPRN-UMIN000010058已完成未知
The Effect of Elemental Dietary Therapy Combined with Infliximab in Patients with Crohn's Disease Intractable to Infliximab Remission Maintenance Therapy (CERISIER-Trail) - CERISIER-Trial;Combination of Elemental Dietary Therapy and Infliximab for Secondary Failure to Infliximab in Patients with Crohn's Disease
Japanese Society of Inflammatory Bowel Disease0 个研究点目标入组 135 人开始时间: 2013年2月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 135
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
- 16years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients who have received the treatments stated below during the following treatment periods as indicated by the number of weeks in parentheses * Biological agents other than infliximab (0-16 weeks) * Cyclosporine or tacrolimus (0-8 weeks) * Methotrexate (0-12 weeks) * Surgery for Crohn's disease (0-16 weeks) * Total parenteral nutrition (TPN) (0-16 weeks) * Enteral nutrition at more than 300 kcal/day (0-8 weeks) * Corticosteroids at doses equivalent to or exceeding 20-mg/day prednisolone (0-4 weeks) 2) Patients who started one of the following therapies or changed the dosage of the drugs * Corticosteroids (0-4 weeks) * Azathioprine or mercaptopurine (0-16 weeks) * Metronidazole or ciprofloxacin (0-4 weeks) * 5-ASA reagents, including salazosulfapyridine (0-4 weeks) * Enteral nutrition (0-8 weeks), except the Elental receptivity test period 3) Patients with colorectal or ilecolonic Crohn's disease only with an anastomotic ulcer after enterocolostomy 4) Patients with severe stenosis in the ileum, colon, and rectum 5) Patients who underwent a colostomy 6) Patients with short bowel syndrome 7) Patients who are scheduled to have surgery for Crohn's disease during this trial 8) Patients with severe infectious disease or complications due to infection within 1 year prior to the trial 9) Patients with intra-abdominal abscess 10) Patients with a serum creatinine level of >2.0 mg/dL 11) Patients with a total bilirubin of >3.0 mg/dL or AST or ALT of >100 IU/L 12) Patients with a history of severe drug allergy 13) Patients with malignancy 14) Patients with mental manifestation 15) Patients with a history or complications of drug or alcohol dependency 16) Patients who are pregnant or likely to be pregnant 17) Patients who participated in another clinical trial within 12 weeks prior to the trial 18) Patients who are considered to be unsuitable by the trial investigators
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