EUCTR2009-013890-16-PT进行中（未招募）不适用
Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1- Must be eligible to start infliximab treatment according to the Portuguese approved Summary of Product Characteristics
- •2- Patients older than 18 years of age up to 65 years of age at the time of informed consent, of both gender and any race.
- •3- Patients with moderate to severe UC - Mayo Score (6-12); endoscopic subscore =2
- •4.1 Patients must have responded inadequately to corticosteroids at least a dose of 40mg/day with or without 5-ASA or patients steroid-dependent
- •4.2- Patients must have responded inadequately to azathioprine or 6-MP (treatment with thiopurines must be at least 3 months in duration) or be intolerant to these agents.
- •5- Patients must be naïve to infliximab or other anti-TNF agents
- •6- No history of latent or active TB prior to screening. No signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- •7- Patients must be capable of providing written informed consent prior to trial entry.
- •8- Subjects must be willing and able to adhere to visit protocol schedule and procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1- Any Contraindication as specified in the Portuguese infliximab approved Summary of Product Characteristics (See Supplement 15.3)
- •2- Patients with severe anemia (haemoglobin<8.0 g/dL)
- •3- Any malignancy in the past 5 years, including lymphoproliferative disorders
- •4- Existence of not removed adenomatous polyps
- •5- History of opportunistic infections in the last 6 months
- •6- Subjects who have a known viral infection such as CMV, HIV, HBV or HCV
- •7- Patients with a history of demyelinating diseases
- •8- Pregnant or breastfeeding women
- •9- Topical treatment with 5-ASA and steroids
- •10-Patients with only rectal involvement
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