Role of bowel ultrasonography to guide treatment with vedolizumab in patients with Crohn's disease and ulcerative colitis

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

• Registration Number: DRKS00013220
• Lead Sponsor: Takeda Pharma Vertrieb GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-20
• Study Completion: 2021-06-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Inclusion criteria for patients with active disease (study part 1):
1. Reliable diagnosis of Crohn's disease (active disease):
a. HBI = 7 and
b. Sonographic signs of active inflammation: intestinal wall thickness> 3.0 mm (colon) or> 2.0 mm (terminal ileum)
OR
Reliable diagnosis of ulcerative colitis (active disease):
a. SCCAI = 5 and
b. Sonographic signs of active inflammation:
Intestinal wall thickness> 3.0 mm (Colon)
2. Study-independent therapy with vedolizumab
according to medical practice
3. Age 18 to 70 years
4. Sufficient communication skills in the German language
5. Patient must be able to recognize the nature, significance and scope of this study and to orientate its will accordingly
Inclusion criteria for patients in remission (study part 2):
1. Reliable diagnosis of Crohn's disease (remission): HBI = 4
OR
Reliable diagnosis of ulcerative colitis (remission):
SCCAI = 5
2. Study-independent therapy with vedolizumab
according to medical practice
3. Age 18 to 70 years
4. Sufficient communication skills in the German language
5. Patient must be able to recognize the nature, significance and scope of this study and to orientate its will accordingly

Exclusion Criteria

1. Pregnancy or breastfeeding
2. Therapy with vedolizumab out of authorization
3. Contraindication to treatment with vedolizumab (sec.reg. FI)
4. Severe symptomatic strictures without signs of blood flow
5. Ileostoma or ileoanal pouch
6. Infectious colitis (e.g., Clostridium difficile colitis,
Cytomegalovirus colitis)
7. Obesity = grade I (BMI> 30) (insufficient, sonographic bowel wall imaging)
8. Ulcerative colitis: proctitis Crohn's disease: infestation of the upper GI tract (esophagus, stomach)
9. Participation in an intervention study within the last 30 days prior to initiation of therapy
10. Other medical reasons

Study & Design

• Study Type: observational
• Study Design: Not specified