EUCTR2013-003199-11-FR进行中（未招募）1 期
Changing the coUrse of cRohn’s disease with an Early use of adalimumab: CURE STUDY - CURE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GETAID
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patient aged 18 to 75
- •2.Patient with early luminal Crohn’s disease (less than 24 months since diagnosis),
- •-intolerant to immunosuppressants or steroids, or
- •-primarily not responders to immunosuppressants for at least 3 months [azathioprine: at least 2.5 mg/kg/d; 6-mercaptopurine: at least 1.5 mg/kg/d; methotrexate: 25 mg/week (subcutaneous or intramuscular route)], and/or
- •-not responder to steroids [prednisolone equivalent at least 40 mg/d], and/or
- •-steroid-dependent [unable to reduce corticosteroids below the equivalent of prednisolone 10 mg/d or budesonide < 6 mg/d within 3 months of starting corticosteroids without recurrent active disease, or who have a relapse within 3 months of stopping corticosteroids],
- •4.Patient with CDAI > 150,
- •5.Patient with at least one ulcer in at least one affected segment (Magnetic Resonance Imaging (MRI) of gastrointestinal tract or colonoscopy conducted after failure of conventional therapy and within 12 weeks before inclusion in the study, or capsule endoscopy
- •6.Patient naïve for all biologics known to be effective for Crohn's Disease
- •7.Patient whose physician decides to start adalimumab as monotherapy independently from the study protocol,
- •8.Patient followed in a centre belonging to the GETAID network.
- •9.Written consent.
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patient Active with complex perianal fistula according to the definition of the American Gastroenterological Association (AGA) [high anal fistula, abscess, proctitis, multiple external openings],
- •-Patient with stoma,
- •-Pregnant or breastfeeding women, absence of contraception
- •-Patient with any contra-indication to adalimumab.
- •-Patient with any contra-indication to MRI
- •-Minors and people unable to give their consent (because of their physical or mental state).
- •-Subject who has not given his/her consent to participate.
- •-Subject participating in another study.
研究者
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