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

NCT ID: NCT05817942

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-12

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Keywords

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filgotinib safety efficacy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm A: Filgotinib

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

Filgotinib

Intervention Type DRUG

Jyseleca

Interventions

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Filgotinib

Jyseleca

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alfasigma S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfasigma Study Director

Role: STUDY_DIRECTOR

Alfasigma S.p.A.

Locations

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LKH - Universitätsklinikum Graz

Graz, , Austria

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Klinikum Klagenfurt am Wörthersee

Klagenfurt, , Austria

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KH der Barmherzigen Brüder St.Veit an der Glan

Sankt Veit an der Glan, , Austria

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AKH - Medizinische Universität Wien

Vienna, , Austria

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Imeldaziekenhuis

Bonheiden, , Belgium

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CHU Saint-Pierre

Brussels, , Belgium

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Cliniques Universitaires de Bruxelles Hopital Erasme

Brussels, , Belgium

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UZA

Edegem, , Belgium

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AZ Maria Middelares

Ghent, , Belgium

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AZ Sint-Lucas

Ghent, , Belgium

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Universitair Ziekenhuis Gent

Ghent, , Belgium

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Sint-Franciscus ziekenhuis

Heusden-Zolder, , Belgium

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UZ Leuven

Leuven, , Belgium

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CHU de Liège

Liège, , Belgium

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Clinique CHC MontLégia

Liège, , Belgium

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AZ Damiaan

Ostend, , Belgium

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CHU Amiens - Hopital Sud

Amiens, , France

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Hôpital Jean Minjoz

Besançon, , France

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Clinique Abroise Paré

Clichy, , France

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CHU de Grenoble - Hôpital Nord

Grenoble, , France

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CHU Lille - Hôpital Claude Huriez

Lille, , France

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CHU Montpellier- Hôpital Saint Eloi

Montpellier, , France

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CHRU de Nancy

Nancy, , France

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CHU Nantes - Hôtel Dieu

Nantes, , France

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Hôpital Saint-Louis

Paris, , France

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CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, , France

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

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CHU Saint Etienne - Hôpital Nord

Saint-Etienne, , France

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Hôpital Rangueil

Toulouse, , France

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Synesis GmbH

Grünwald, Bavaria, Germany

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Klinikum St. Marien Amberg

Amberg, , Germany

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Medizinisches Versorgungszentrum Dachau

Dachau, , Germany

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Fachinternistische Schwerpunktpraxis

Hamburg, , Germany

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Praxis fur Gastroenterologie

Heidelberg, , Germany

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Universitaetsklinikum Schleswig-Holstein

Kiel, , Germany

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Universitätsklinikum Leipzig AöR

Leipzig, , Germany

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Gastro Campus Research GbR

Münster, , Germany

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Magen-Darm-Zentrum Remscheid

Remscheid, , Germany

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Universitätsklinikum Tübingen

Tübingen, , Germany

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Cork University Hospital

Cork, , Ireland

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St Vincent's University Hospital

Dublin, , Ireland

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Beaumont Hospital

Dublin, , Ireland

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Azienda Ospedaliera Saverio De Bellis - Castellana Grotte

Bari, Italia, Italy

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IRCCS Ospedale San Raffaele ,Via Olgettina 60

Milan, Italia, Italy

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Azienda Ospedaliero Universitaria Pisana - Cisanello

Pisa, Italia, Italy

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Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, , Italy

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ASST Fatebenefratelli Sacco

Milan, , Italy

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IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

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Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, , Italy

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IRCCS Istituto Clinico Humanitas

Rozzano, , Italy

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Ospedale Mauriziano Umberto I

Torino, , Italy

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Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

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Amsterdam UMC (AMC)

Amsterdam, , Netherlands

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Zuyderland Medisch Centrum - Sittard-Geleen

Geleen, , Netherlands

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Radboud UMC

Nijmegen, , Netherlands

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Erasmus MC

Rotterdam, , Netherlands

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Franciscus Gasthuis

Rotterdam, , Netherlands

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ETZ Elisabeth

Tilburg, , Netherlands

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UMC Utrecht

Utrecht, , Netherlands

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Nordlandsykehuset

Bodø, , Norway

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Akershus Universitetssykehus

Lørenskog, , Norway

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Oslo University Hospital

Oslo, , Norway

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Bærum Hospital , Gjettum

Oslo, , Norway

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Universitetssykehuset Nord-Norge

Tromsø, , Norway

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St. Olav's University Hospital

Trondheim, , Norway

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Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

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Hospital Universitari Germans Trias i Pujol

Badalona, Spain, Spain

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Hospital Clinic de Barcelona, C/ Villarroel, 170

Barcelona, Spain, Spain

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Hospital Universitario de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Spain, Spain

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Hospital Universitari Son Espases

Palma de Mallorca, Spain, Spain

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Hospital Universitario de Santiago de Compostela

Santiago de Compostela, Spain, Spain

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The Ulster Hospital

Belfast, , United Kingdom

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Bury Care Organisation

Bury, , United Kingdom

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Royal Devon University Healthcare NHS Foundation trust

Exeter, , United Kingdom

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Glasgow Royal Infirmary

Glasgow, , United Kingdom

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Queen Elizabeth University Hospital

Glasgow, , United Kingdom

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St Mark's Hospital, Central Middlesex, Acton Lane

London, , United Kingdom

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St George's Hospital

London, , United Kingdom

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Norfolk and Norwich University Hospital

Norwich, , United Kingdom

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John Radcliffe Hospital

Oxford, , United Kingdom

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Southampton General Hospital

Southampton, , United Kingdom

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Countries

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Austria Belgium France Germany Ireland Italy Netherlands Norway Spain United Kingdom

Other Identifiers

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105477

Identifier Type: OTHER

Identifier Source: secondary_id

GLPG0634-CL-425

Identifier Type: -

Identifier Source: org_study_id