Filgotinib in the treatment of patients with ulcerative colitis: towards precision medicine (TOPS study)

Recruiting

• Conditions: Ulcerative colitis; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON53453
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Previously (>=3 months) documented diagnosis of ulcerative colitis
- Moderately to severe ulcerative colitis, defined as a Mayo score of 6-12.
- Age >= 18 years
- Indication for the start of filgotinib, as determined by the treating
physician(s)

Exclusion Criteria

- No informed consent has been obtained
- The patient is diagnosed with Crohn*s disease
- The concomitant use of biological medication
- Previous failure of a JAK-inhibitor
- Recent (<4 weeks) start or intensification of other topical or systemic
treatments for UC
- Immunodeficiency (e.g. HIV, SCID)
- Acute severe ulcerative colitis
- Pregnancy or lactating female

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical response at 24 weeks, defined as a corticosteroid-free reduction of 3<br /><br>or more points in the Mayo Clinical Score and at least 30% from induction<br /><br>baseline with an accompanying decrease in rectal bleeding subscore of 1 point<br /><br>or more, or an absolute rectal bleeding subscore of 0 or 1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>