NL-OMON36566已完成4 期
A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study - Withdrawal of mesalazine in Crohn's Disease patients
niversitair Medisch Centrum Utrecht0 个研究点目标入组 906 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 906
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
- 18 至 99（—）
入选标准
- •18 years or older
- •- Mesalazine maintenance therapy >1 year
- •- Quiescent disease (definition: CDAI <150)
- •- Written informed consent
排除标准
- •- Flare-up(s) of CD within 12 months preceding inclusion
- •- Treatment with prednisone, budesonide, infliximab, adalumimab of ceroluzimab within 12 months of inclusion
- •- Treatment with methotrexate, mercaptopurine or azathioprine, when initiated within 6 months prior to inclusion
- •- Extra-intestinal CD manifestations such as fistulas or pyoderma gangrenosum demanding induction therapy
- •- Treatment with enteral or parenteral feeding within 6 months prior to inclusion
- •- Treatment with metronidazole, ciprofloxacin, rectal steroids or rectal aminosalicylates within 12 months prior to inclusion
- •- Previous ileo-colorectal resection, such as small bowel resections >100 cm, total proctocolectomy, subtotal colectomy, colostomy or ileostomy
- •- Primary sclerosing cholangitis (PSC)
- •- Hypersensitivity to mesalazine
- •- Disorders, which are likely to require systemic steroids (e.g. asthma)
- •- Abnormalities in liver function tests (definition: 2x upper limit of normal value of ALAT. Normal values ALAT: > 45 U/L (men) of >35 U/L (women)
- •- Abnormalities in kidney function tests (definition: creatinin > 120 µmol/L (men) or
- •>103 µmol/L (women)
- •- Dysplasia or neoplasia of the colon
- •- Pregnant or lactating women
研究者
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A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years or older. 3. Patients with mesalazine maintenance therapy > 1 year.MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's diseaseEUCTR2009-011220-62-NLniversity Medical Center Utrecht
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