EUCTR2009-011220-62-NL进行中（未招募）不适用
A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- 18 years or older
- •- Mesalazine maintenance therapy >1 year
- •- Quiescent disease (definition: CDAI <150)
- •- Written informed 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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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