Predictive value of ultrasonographic parameters fortherapy response in Crohn’s disease and ulcerativecolitis patients

• Conditions: K50; K51; Crohn disease [regional enteritis]; Ulcerative colitis

• Registration Number: DRKS00016731
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Study Completion: 2024-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

Written informed consent
- Patients = 18 years
- CD: Patients with a proven diagnosis of Crohn’s disease or ulcerative colitis, and moderate to severe disease activity who have been selected for start of TIM therapy.
- Patients with increased bowel wall thickness (BWT) at baseline

Exclusion Criteria

- Patients post bowel resection surgery, patients with ileal stoma or ileoanal pouch
- CD patients with disease restricted to small bowel other than terminal ileum, gastroduodenal or anorectal areas
- UC patients having disease limited to the rectum (ulcerative proctitis)
- Patients with therapy failure to more than 2 prior biologics/JAK-therapy
- Patients who cannot be examined by ultrasound
- Pregnant at study start
- Infectious colitis (e.g. Cytomegalovirus (CMV), Clostridium Difficile (C.diff)
- Preparation of endoscopy at day of Gastrointestinal Ultrasound (GIUS) assessment or on the day before

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with therapeutic remission at week 52 defined as clinical remission / steroid-free remission (HBI <5 or CD (Crohn’s Disease) or SCCAI = 2 for UC / no use of steroids for = 8 weeks).