DRKS00023031招募中不适用
A multicentre prospective longitudinal observational study to evaluate biomarkers and mechanistic principles in moderate to severe ulcerative colitis (UC) patients treated with different targeted therapies - ImmUniverse UC
niversitätskliniikum Schleswig-Holstein, Campus Kiel Klinik für Innere Medizin I für die deutschen Partner der multizentrischen Studie0 个研究点目标入组 270 人开始时间: 2020年9月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Signed written Informed Consent
- •2. Established diagnosis of ulcerative colitis with a minimum disease duration of 3 months
- •3. Moderate to severe active UC, defined by Mayo Score = 6 including endoscopy score of = 2
- •4. Indication to start any biological or small molecule agent (anti-TNF, anti- IL12/23, anti-integrin and JAK-inhibitors)
- •5. In case of treatment with corticosteroid: stabile dose for at least 3 weeks prior to baseline, dosage = 20 mg prednisone
- •6. Indication for colonoscopy for the assessment of disease activity as for standards of care and current guidelines
- •7. Able to comply with the study procedures
排除标准
- •1. Diagnosis of indeterminate colitis, microscopic colitis, ischaemic colitis, infectious colitis, radiation colitis
- •2. Absolute contraindications to colonoscopy procedures, complication during previous endoscopy
- •3. Bleeding disorders
- •4. Indication for surgery for UC
- •5. Legal incapacity
- •6. Rectal topical therapy (enemas or suppositories) = 2 weeks prior to baseline
- •7. Treatment with > 20 mg prednisone within 3 weeks prior to baseline
- •8. anaemia (haemoglobin < 10 g/dl) at baseline
- •9. Pregnant or breastfeeding women
- •10. Any circumstances which could contradict a study participation and lead the Investigator to assess the patient as unsuitable for study participation for any other reason
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