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

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Filgotinib

• Registration Number: NCT05817942
• Lead Sponsor: Alfasigma S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-18
• Study Start: 2023-06-12
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-22
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A: Filgotinib	Filgotinib	Participants diagnosed with moderately or severely active UC taking filgotinib according to local treatment guidelines or routine clinical practice and product information.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants with Serious Adverse Events (SAEs)	Up To 104 Weeks
Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)	Baseline, Weeks 10, 24, 52
Number of Participants with Adverse Events (AEs)	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
Clinical Remission Rate	Weeks 10, 24, 52, 76 and 104
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 Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F)	Baseline, Weeks 10, 24, 52, 76 and 104

Trial Locations

Locations (83)

LKH - Universitätsklinikum Graz; 🇦🇹 Graz, Austria

Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt am Wörthersee, Austria

KH der Barmherzigen Brüder St.Veit an der Glan; 🇦🇹 St. Veit an der Glan, Austria

AKH - Medizinische Universität Wien; 🇦🇹 Wien, Austria

Imeldaziekenhuis; 🇧🇪 Bonheiden, Belgium

CHU Saint-Pierre; 🇧🇪 Brussels, Belgium

Cliniques Universitaires de Bruxelles Hopital Erasme; 🇧🇪 Bruxelles, Belgium

UZA; 🇧🇪 Edegem, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Belgium

AZ Sint-Lucas; 🇧🇪 Gent, Belgium

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