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

NCT05817942 · tracked via the Priya Life Science UK tracker

Sponsor

Alfasigma S.p.A.

Phase

Observational

Started

2023-06-12

Last updated

2025-12-24

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Filgotinib

Filgotinib: Jyseleca

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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.

Primary outcome measure(s)

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.

Trial sites (81)

Facility	City	Region
LKH - Universitätsklinikum Graz	Graz	Austria
Klinikum Klagenfurt am Wörthersee	Klagenfurt	Austria
KH der Barmherzigen Brüder St.Veit an der Glan	Sankt Veit an der Glan	Austria
AKH - Medizinische Universität Wien	Vienna	Austria
Imeldaziekenhuis	Bonheiden	Belgium
CHU Saint-Pierre	Brussels	Belgium
Cliniques Universitaires de Bruxelles Hopital Erasme	Brussels	Belgium
UZA	Edegem	Belgium
AZ Maria Middelares	Ghent	Belgium
AZ Sint-Lucas	Ghent	Belgium
Universitair Ziekenhuis Gent	Ghent	Belgium
Sint-Franciscus ziekenhuis	Heusden-Zolder	Belgium
UZ Leuven	Leuven	Belgium
CHU de Liège	Liège	Belgium
Clinique CHC MontLégia	Liège	Belgium
AZ Damiaan	Ostend	Belgium
CHU Amiens - Hopital Sud	Amiens	France
Hôpital Jean Minjoz	Besançon	France
Clinique Abroise Paré	Clichy	France
CHU de Grenoble - Hôpital Nord	Grenoble	France
CHU Lille - Hôpital Claude Huriez	Lille	France
CHU Montpellier- Hôpital Saint Eloi	Montpellier	France
CHRU de Nancy	Nancy	France
CHU Nantes - Hôtel Dieu	Nantes	France
Hôpital Saint-Louis	Paris	France
CHU Bordeaux - Hôpital Haut-Lévêque	Pessac	France
Centre Hospitalier Lyon Sud	Pierre-Bénite	France
CHU Saint Etienne - Hôpital Nord	Saint-Etienne	France
Hôpital Rangueil	Toulouse	France
Synesis GmbH	Grünwald	Bavaria
Klinikum St. Marien Amberg	Amberg	Germany
Medizinisches Versorgungszentrum Dachau	Dachau	Germany
Fachinternistische Schwerpunktpraxis	Hamburg	Germany
Praxis fur Gastroenterologie	Heidelberg	Germany
Universitaetsklinikum Schleswig-Holstein	Kiel	Germany
Universitätsklinikum Leipzig AöR	Leipzig	Germany
Gastro Campus Research GbR	Münster	Germany
Magen-Darm-Zentrum Remscheid	Remscheid	Germany
Universitätsklinikum Tübingen	Tübingen	Germany
Cork University Hospital	Cork	Ireland

+ 41 more sites — see the full list on the official registry below.

More Alfasigma S.p.A. trials in the UK

Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents Recruiting

OLE Study With Filgotinib in JIA Recruiting

A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Recruiting

Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis Active, not recruiting

A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis Active, not recruiting

Other trials for the same condition

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) Active, not recruiting

Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population Active, not recruiting

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05817942 on ClinicalTrials.gov ↗ ← All trials in the UK