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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53453

Enrollment

Registered

2023-02-28

Start date

2023-06-13

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

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

Countries

Netherlands

Outcome results