JPRN-UMIN000005146已完成4 期
Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study) - Study of Combination Therapy of Adalimumab and an Immunomodulator for Crohn's Disease(Diamond study)
Department of Internal Medicine, School of Medicine, Keio University0 个研究点目标入组 200 人开始时间: 2011年2月25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
- 200
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
- 15years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Adalimumab contraindication 1)Patients with severe infection (Sepsis, etc) 2)Patients with active tuberculosis 3)Patients with history of hypersensitivity to any of the other ingredients of Adalimumab 4)Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease 5)Patients with congestive heart failure (2)Azathioprine contraindication 1)Patients with history of hypersensitivity to any of the other ingredients of Azathioprine 2)Patients with the number of leukocytes ≤ 3000/mm3 3)Pregnant or likely to be pregnant women (3)Pregnant or lactating women (4)Patients < 20 years of age (5)Patients not approving the study consent (6)Patients who have ever received anti-TNF antibodies before (7)Patients who have received immunomodulators like Azathioprine, 6-mercaptopurine, Tacrolimus and Methotrexate (8)Patients with malignancy (9)Patients in 6 months after surgery (10)Patients with short bowel syndrome (11)Patients judged as inadequate at the discretion of physicians
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