DRKS00030595招募中未知
Validation of an Intestinal Ultrasound Evaluating Inflammation and Treatment Response in Crohn´s Disease (USE-IT): A Prospective Multicenter Study - USE-IT
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 111
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Participants must meet each of the following criteria for enrolment into the study:
- •1. Confirmed diagnosis of CD according to standard clinical, endoscopic, and histologic criteria of at least 3 months duration
- •2. Adults 18 years of age or older
- •3. Moderate to severely active CD defined by:
- •a. Active symptoms with an HBI score = 5, and
- •b. Bowel wall inflammation defined as BWT > 3 mm in at least 1 segment of the ileum or colon as determined by IUS
- •4. Patients with planned introduction of an SOC biologic and/or JAK inhibitor therapy approved for CD as per their treating gastroenterologist to treat active disease
- •5. Written informed consent must be obtained and documented
排除标准
- •Patients who exhibit any of the following conditions are to be excluded from the study:
- •1. Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified
- •2. Patients with prior intestinal surgery
- •3. Disease-related structural bowel complications as defined by CONSTRICT criteria:11
- •a. Localized luminal narrowing (luminal diameter reduction of at least 50% relative to normal adjacent bowel loop), and
- •b. Bowel wall thickening (25% increase relative to adjacent unaffected bowel), and
- •c. Either: maximum associated small bowel dilation (luminal diameter greater than or equal to 3 cm) OR inability to pass an adult or pediatric colonoscope through the narrowed area prior to dilation and unequivocal proximal small bowel dilation (but may be less than 3 cm). Endoscopic diagnosis of stricture should be within 6 months of MRE
- •4. Disease-related penetrating complications (excluding perianal fistulizing disease; patients with perianal disease are eligible if there is additional inflammation in another bowel segment [other than the rectum])
- •5. Contraindication to IC or MRE
- •6. BMI greater than 35 at time of screening or other characteristics considered likely to preclude IUS visualization of all bowel segments
- •7. Disease limited to the rectum
- •8. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant’s ability to participate fully in the study
- •9. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant’s ability to comply with the study procedures
- •10. Pregnancy and female patients of child-bearing potential planning a pregnancy during the study period
研究者
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