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Clinical Trials in Italy / NCT05817942
Active, not recruiting Observational

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

NCT05817942 · tracked via the Priya Life Science Italy 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
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.

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)

FacilityCityRegionStatus
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 Italy

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
Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents Recruiting
A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis Active, not recruiting

Other trials for the same condition

Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis Starting soon
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis: Recruiting
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Recruiting
A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis Recruiting
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD Enrolling by invitation
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 Italy