DRKS00032030招募中Unknown
GUIDE-IBD - Molecular Therapy Guidance in Inflammatory Bowel Disease - GUIDE-IBD
niversitätsklinikum Schleswig-Holstein, Campus Kiel0 个研究点目标入组 100 人开始时间: 2023年6月9日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •The patient gave written consent to the study
- •-Diagnosis of CD/UC confirmed since 3 months
- •-Active moderate-to-severe disease despite medication with 5-ASA, budesonide (max 9mg/d), and/or other immunosuppressants like AZA, 6-MP and MTX
- •oCD: CDAI 221-450 (or PRO2 14-34), CDEIS = 6 with Ulcers in min. 1 segment
- •oUC: Mayo-Score = 6 with Bleeding/diarrhea score of each = 2 and endoscopic mayo score = 2
- •-Indication for i.v. anti-TNF therapy and completed shared therapy decision through treating physician/patient
- •-Patient is Biologics/JAK inbibitor naive
- •-If anti-inflammatory medication is taken:
- •oDosing within the respective indication (Mesalamine/5-ASA, sulfasalazine, azathioprine, 6-mercaptopurine, methotrexate)
- •oPrednisolone max. 20mg/d at inclusion
排除标准
- •-Other diagnosis or causes of intestinal inflammation, like indeterminate colitis, microscopic colitis, infectious colitis, ischemic colitis, radiation-induced colitis
- •-Prior peri-interventional complications in endoscopic assessments
- •-Patient does not understand the study or is not able to attend the scheduled visits
- •-Hemoglobin levels <10 g/dl
研究者
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