Monitoring of Vedolizumab Infusion Therapy response with fecal calprotectin, ultrasound and trough serum level in Ulcerative colitis. A multicentric, prospective non-interventional Study - MOVE-IT

Internistische Gemeinschaftspraxis0 个研究点目标入组 50 人开始时间: 2018年7月18日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Reliable diagnosis of ulcerative colitis> 3 months (endoscopically and clinically)
•2. Secured disease due to increased fecal calprotectin = 100 µg / g and / or endoscopic score UCEIS = 3, within 3 weeks prior to baseline
•3. Ultrasound detectable disease; Sonographic signs of active inflammation, determined by the thickness of the intestinal wall:> 3 mm (colon)
•4. If treatment with vedolizumab independent of the present study has been performed in accordance with routine medical practice, there should be at least a 12 week break between end and beginning
•5. Age between = 18 and 80 years
•6. Signed written consent is available

•1. Pregnancy and lactation
•2. Indication for vedolizumab therapy outside the product information
•3. Contraindications for treatment with vedolizumab (according to product information)
•4. ileostomy or ileoanal pouch
•5. Infectious colitis (e.g., Clostridium difficile colitis, cytomegalovirus colitis)
•6. Obesity = Grade I (BMI> 30): inadequate sonographic log wall imaging
•7. Proctitis
•8. Participation in an intervention study within the last 30 days prior to initiation of therapy.
•9. Other medical reasons.

发起方

Internistische Gemeinschaftspraxis