Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) (GALOCEAN)

Alfasigma

Status: Active, not recruiting

Conditions: Ulcerative Colitis

Treatments: Drug: Filgotinib

Study type: Observational

Funder types: Industry

Identifiers

NCT05817942

105477 (Other Identifier)

GLPG0634-CL-425

Details and patient eligibility

About

To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.

Enrollment: 509 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Filgotinib-naïve participants with moderately or severely active UC as judged by the physician and starting filgotinib treatment according to local treatment guidelines, routine practices and product information.

Exclusion criteria

1. Participation in any interventional or non-interventional study without prior approval from the medical leader. This does not preclude inclusion of participants enrolled to national registries.
2. Participant is diagnosed with Crohn's disease.

Trial design

509 participants in 1 patient group

Arm A: Filgotinib

Description:

Participants diagnosed with moderately or severely active UC taking filgotinib according to local treatment guidelines or routine clinical practice and product information.

Treatment:

Drug: Filgotinib