JPRN-UMIN000006889已完成4 期
Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy - Infliximab-GMA Effect of Loss of Response; INGRESS study
Department of Lower Gastroenterology, Hyogo College of Medicine0 个研究点目标入组 50 人开始时间: 2012年1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
- 50
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 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Cases that granulocyte count below 2000/mm3 (2) Cases that complication by infection present or suspected (3) Patients with severe heart disease (4) Patients with severe kidney disease (5) Patients with hypotension (Systolic blood pressure less than 80mmHg) (6) Patients willing or being pregnant (or lactation). (7) Patient with severe dehydration and/or hyper-viscosity. Patients with severe anemia (Hb <8g/dL) (8) Patients with malignant tumor (9) Patients with colostomy (10) Patients with uncontrollable external-fistulas. (11) Patients with intestinal stenosis. (12) Patients with severe extra-intestinal complications. (13) Patients with short bowel syndrome. (14) Patients after total colectomy. (15) Patients who have been treated with corticosteroids (iv, po, or topical) within 2 weeks. (16) Patients who have treated with intravenous hyperalimentation (IVH) within 4 weeks. (17) Patients who have been given more than 1,200kcal of elemental nutrition within 4 weeks. (18) Patients who have episode of starting or increasing dosage of thioprine within 8 weeks. (19) Patients who do not submit informed consent (20) Patients who have been treating with non-approval therapy and/or enrolling other clinical trials. (21) Other patients judged as inappropriate by the physician
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