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

Conditions

Ulcerative Colitis

Keywords

filgotinib, safety, efficacy

Brief summary

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.

S W Schreiber, M Löwenberg, W Reinisch, J P Seenan, M L Høivik et al. (14 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.073

P1068 Real-world effectiveness of filgotinib by prior advanced treatment and predictors of clinical response in Ulcerative Colitis: Interim results up to week 24 from the prospective, observational GALOCEAN study

W Reinisch, M Löwenberg, A Armuzzi, E Ricart Gomez, C Gilletta de Saint Joseph et al. (14 authors)

Journal of Crohn s and Colitis2026-01-01

10.1093/ecco-jcc/jjaf231.1249

P1140 Filgotinib effectiveness and safety in moderate and severely active patients with Ulcerative Colitis: early real-world outcomes in an interim analysis of data from the prospective, observational GALOCEAN study

John Paul Seenan, Marte Lie Høivik, Séverine Vermeire, S Schreiber, Walter Reinisch et al. (14 authors)

Journal of Crohn s and Colitis2025-01-01

10.1093/ecco-jcc/jjae190.1314

P1017 Real-world effectiveness and safety of filgotinib with and without concomitant therapies in patients with Ulcerative Colitis: an interim analysis of the prospective, observational GALOCEAN study

M Høivik MD-, Séverine Vermeire, Walter Reinisch, John Paul Seenan, Mark Löwenberg et al. (14 authors)

Journal of Crohn s and Colitis2025-01-01

10.1093/ecco-jcc/jjae190.1191

Interventions

DRUGFilgotinib

Jyseleca

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Treatment Persistence Rate at week 52.	Week 52	The persistence rate is defined as the percentage of participants who have continued filgotinib treatment since initiation.

Secondary

Measure	Time frame
Number of Participants with Serious Adverse Events (SAEs)	Up To 104 Weeks
Treatment Persistence Rate at weeks 10, 24, 76 and 104	Weeks 10, 24, 76 and 104
Clinical Response Rate	Weeks 10, 24, 52, 76 and 104
Number of Participants with Adverse Events (AEs)	Up to 104 Weeks
Change from Baseline in Health-Related Quality of Life (HRQoL) as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	Baseline, Weeks 10, 24, 52, 76 and 104
Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)	Baseline, Weeks 10, 24, 52
Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F)	Baseline, Weeks 10, 24, 52, 76 and 104
Clinical Remission Rate	Weeks 10, 24, 52, 76 and 104

Countries

Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, United Kingdom

Outcome results

None listed