TRansabdominal UltraSonography of the bowel To monitor disease activity in Subjects with Ulcerative Colitis
- Conditions
- Ulcerative colitis, unspecifiedK51.9
- Registration Number
- DRKS00008990
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 225
Inclusion Criteria
Patients = 18 years
- Patients with a proven diagnosis of proctosigmoiditis, left-sided colitis or pancolitis and currently at relapse (SCCAI = 5)
Exclusion Criteria
- Patients having disease limited to the rectum (ulcerative proctitis)
- Pregnancy
- Patients with ileal stoma or ileoanal pouch
- Infectious colitis (e.g. CMV, C. diff.)
- Preparation for colonoscopy at day of US examination or the day before
- Patients not capable of signing written consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the decrease of bowel wall thickening in patients with clinical response at week 6 and/or week 12.
- Secondary Outcome Measures
Name Time Method - the correlation of calprotectin with clinical response<br>- the correlation of CRP with clinical response<br>- the change of US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) in patients with clinical response at week 6 and/or week 12.<br>- the change of US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) in patients with clinical remission at week 6 and/or week 12<br>- does sonographic non-response at week 6 in patients with clinical response at week 6 predict early relapse before or by week 12?<br>- the correlation of calprotectin with US parameters (e.g. bowel wall thickness, bowel wall stratification, mesenteric proliferation, lymphnodes) at week 6 and/or week 12<br>