EUCTR2006-005299-42-BE进行中（未招募）不适用
A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GETAID
- 入组人数
- 100
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
- •- Age > 18 years.
- •- Diagnosis of UC according to Lennard-Jones criteria (Appendix 1).
- •- Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.
- •- Severe acute flare of UC with a Lichtiger Index score > 10 (Appendix 2).
- •- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
- •- Adequate contraception for male or female subjects of childbearing potential, which will be continued throughout the study and at least 3 months after study termination.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Pregnant or breast-feeding woman.
- •-Previous treatment with cyclosporine or infliximab.
- •-Azathioprine or 6-mercaptopurine treatment initiated more than 4 weeks before inclusion.
- •-Indication for immediate surgery.
- •-History of colorectal dysplasia.
- •-Diagnosis of Crohn's disease.
- •-Positive stool tests for amoebiasis and/or positive bacteriological culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools.
- •-Renal failure (creatininemia > upper limit of normal laboratory value).
- •-Uncontrolled high blood pressure.
- •- HIV, HBV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months.
- •-Uncontrolled bacterial or active viral infection.
- •-Past medical history of malignant condition in the last 5 years (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.
- •- Past medical history of myocardial infarction or heart failure.
- •-Intradermal reaction to Tuberculin (Tubertest® 5 units) > 5mm.
- •-Active tuberculosis
- •-Untreated latent tuberculosis (see national recommendations. Appendix 3).
- •-Abnormal blood count with polynuclear neutrophils < 1,500 G/L or white cells < 3,000, or platelets < 100,000 G/L.
- •-Unexplained rise higher than 3 times the normal level for transaminases, alkaline phosphatases and/or higher than twice the normal level for bilirubin.
- •-Non-compliant subjects.
- •-Participation in another therapeutic study.
研究者
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