TRansabdominal Ultrasonography of the bowel in Subjects with Crohn’s disease To monitor disease activity

• Conditions: K50.1; Crohn disease of large intestine

• Registration Number: DRKS00010805
• Lead Sponsor: AbbVie Duetschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-09-03
• Study Start: 2016-07-07
• Results First Posted: 2017-04-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

Patients with a proven diagnosis of ileocecal and / or colonic Crohn's disease and currently at least moderate disease activity (HBI = 7)

Exclusion Criteria

Patients with ileal stoma; Patients post bowel resection surgery; Patients with CD restricted to small bowel, gastroduodenal or anorectal areas; Pregnancy.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change in one or more of selected US parameters within 12 months.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint is the correlation of US changes with HBI changes.