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

Last updated: September 2, 2025
Sponsor: Alfasigma S.p.A.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Colic

Inflammatory Bowel Disease

Ulcers

Treatment

Filgotinib

Clinical Study ID

NCT05817942
GLPG0634-CL-425
EUPAS50214
105477
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Participation in any interventional or non-interventional study without priorapproval from the medical leader. This does not preclude inclusion of participantsenrolled to national registries.

  2. Participant is diagnosed with Crohn's disease.

Study Design

Total Participants: 520
Treatment Group(s): 1
Primary Treatment: Filgotinib
Phase:
Study Start date:
June 12, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • LKH - Universitätsklinikum Graz

    Graz, 8036
    Austria

    Site Not Available

  • LKH - Universitätsklinikum Graz

    Graz 2778067, 8036
    Austria

    Site Not Available

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt 2774326, 9020
    Austria

    Site Not Available

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt am Wörthersee, 9020
    Austria

    Site Not Available

  • KH der Barmherzigen Brüder St.Veit an der Glan

    Sankt Veit an der Glan 2766359, 9300
    Austria

    Site Not Available

  • KH der Barmherzigen Brüder St.Veit an der Glan

    St. Veit an der Glan, 9300
    Austria

    Site Not Available

  • AKH - Medizinische Universität Wien

    Vienna 2761369, 1090
    Austria

    Site Not Available

  • AKH - Medizinische Universität Wien

    Wien, 1090
    Austria

    Site Not Available

  • Imeldaziekenhuis

    Bonheiden, 2820
    Belgium

    Site Not Available

  • Imeldaziekenhuis

    Bonheiden 2801539, 2820
    Belgium

    Site Not Available

  • CHU Saint-Pierre

    Brussels, 1000
    Belgium

    Site Not Available

  • CHU Saint-Pierre

    Brussels 2800866, 1000
    Belgium

    Site Not Available

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels 2800866, 1070
    Belgium

    Site Not Available

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Bruxelles, 1070
    Belgium

    Site Not Available

  • UZA

    Edegem, 2650
    Belgium

    Site Not Available

  • UZA

    Edegem 2799007, 2650
    Belgium

    Site Not Available

  • AZ Maria Middelares

    Gent, 9000
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Gent, 9000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • AZ Maria Middelares

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • Sint-Franciscus ziekenhuis

    Heusden-Zolder, 3550
    Belgium

    Site Not Available

  • Sint-Franciscus ziekenhuis

    Heusden-Zolder 7669241, 3550
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • CHU de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • Clinique CHC MontLégia

    Liège, 4000
    Belgium

    Site Not Available

  • CHU de Liège

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • Clinique CHC MontLégia

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • AZ Damiaan

    Oostende, 8400
    Belgium

    Site Not Available

  • AZ Damiaan

    Ostend 2789786, 8400
    Belgium

    Site Not Available

  • CHU Amiens - Hopital Sud

    Amiens, 80000
    France

    Site Not Available

  • CHU Amiens - Hopital Sud

    Amiens 3037854, 80000
    France

    Site Not Available

  • Hôpital Jean Minjoz

    Besançon, 25000
    France

    Site Not Available

  • Hôpital Jean Minjoz

    Besançon 3033123, 25000
    France

    Site Not Available

  • Clinique Abroise Paré

    Clichy, 92200
    France

    Site Not Available

  • Clinique Abroise Paré

    Clichy 3024597, 92200
    France

    Site Not Available

  • CHU de Grenoble - Hôpital Nord

    Grenoble 3014728, 38043
    France

    Site Not Available

  • CHU de Grenoble - Hôpital Nord

    Grenoble Cedex 09, 38043
    France

    Site Not Available

  • CHU Lille - Hôpital Claude Huriez

    Lille, 59000
    France

    Site Not Available

  • CHU Lille - Hôpital Claude Huriez

    Lille 2998324, 59000
    France

    Site Not Available

  • CHU Montpellier- Hôpital Saint Eloi

    Montpellier, 34090
    France

    Site Not Available

  • CHU Montpellier- Hôpital Saint Eloi

    Montpellier 2992166, 34090
    France

    Site Not Available

  • CHRU de Nancy

    Nancy, 54000
    France

    Site Not Available

  • CHRU de Nancy

    Nancy 2990999, 54000
    France

    Site Not Available

  • CHU Nantes - Hôtel Dieu

    Nantes, 44093
    France

    Site Not Available

  • CHU Nantes - Hôtel Dieu

    Nantes 2990969, 44093
    France

    Site Not Available

  • Hôpital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Hôpital Saint-Louis

    Paris 2988507, 75010
    France

    Site Not Available

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604
    France

    Site Not Available

  • CHU Bordeaux - Hôpital Haut-Lévêque

    Pessac 2987805, 33604
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite 2987314, 69495
    France

    Site Not Available

  • CHU Saint Etienne - Hôpital Nord

    Saint-Etienne 2980291, 42055
    France

    Site Not Available

  • CHU Saint Etienne - Hôpital Nord

    Saint-Étienne, 42055
    France

    Site Not Available

  • Hôpital Rangueil

    Toulouse, 31059
    France

    Site Not Available

  • Hôpital Rangueil

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Synesis GmbH

    Grünwald, Bavaria 82031
    Germany

    Site Not Available

  • Synesis GmbH

    Grünwald 2914064, Bavaria 2951839 82031
    Germany

    Site Not Available

  • Klinikum St. Marien Amberg

    Amberg, 92224
    Germany

    Site Not Available

  • Klinikum St. Marien Amberg

    Amberg 2956656, 92224
    Germany

    Site Not Available

  • Medizinisches Versorgungszentrum Dachau

    Dachau, 85221
    Germany

    Site Not Available

  • Medizinisches Versorgungszentrum Dachau

    Dachau 2939623, 85221
    Germany

    Site Not Available

  • Fachinternistische Schwerpunktpraxis

    Hamburg, 22041
    Germany

    Site Not Available

  • Fachinternistische Schwerpunktpraxis

    Hamburg 2911298, 22041
    Germany

    Site Not Available

  • Praxis fur Gastroenterologie

    Heidelberg, 69115
    Germany

    Site Not Available

  • Praxis fur Gastroenterologie

    Heidelberg 2907911, 69115
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein

    Kiel 2891122, 24105
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig AöR

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig AöR

    Leipzig 2879139, 04103
    Germany

    Site Not Available

  • St. Marienkrankenhaus

    Ludwigshafen am Rhein, 67067
    Germany

    Site Not Available

  • Gastro Campus Research GbR

    Münster, 48159
    Germany

    Site Not Available

  • Gastro Campus Research GbR

    Münster 2867543, 48159
    Germany

    Site Not Available

  • MVZ Internisten am Ring

    Nürnberg, 90489
    Germany

    Site Not Available

  • Magen-Darm-Zentrum Remscheid

    Remscheid, 42859
    Germany

    Site Not Available

  • Magen-Darm-Zentrum Remscheid

    Remscheid 2848273, 42859
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen 2820860, 72076
    Germany

    Site Not Available

  • Cork University Hospital

    Cork, T12 DFK4
    Ireland

    Site Not Available

  • Cork University Hospital

    Cork 2965140, T12 DFK4
    Ireland

    Site Not Available

  • Beaumont Hospital

    Dublin, D09 A0HK
    Ireland

    Site Not Available

  • St Vincent's University Hospital

    Dublin, D04 T6F4
    Ireland

    Site Not Available

  • Beaumont Hospital

    Dublin 2964574, D09 A0HK
    Ireland

    Site Not Available

  • St Vincent's University Hospital

    Dublin 2964574, D04 T6F4
    Ireland

    Site Not Available

  • Azienda Ospedaliera Saverio De Bellis - Castellana Grotte

    Bari, Italia 70013
    Italy

    Site Not Available

  • Azienda Ospedaliera Saverio De Bellis - Castellana Grotte

    Bari 3182351, Italia 70013
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele ,Via Olgettina 60

    Milan 6951411, Italia 20132
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele ,Via Olgettina 60

    Milano, Italia 20132
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana - Cisanello

    Pisa, Italia 56124
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana - Cisanello

    Pisa 3170647, Italia 56124
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco

    Milan 6951411, 20157
    Italy

    Site Not Available

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan 6951411, 20122
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco

    Milano, 20157
    Italy

    Site Not Available

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Site Not Available

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, 37024
    Italy

    Site Not Available

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar 3172338, 37024
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo 2523920, 90146
    Italy

    Site Not Available

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • IRCCS Istituto Clinico Humanitas

    Rozzano 3168837, 20089
    Italy

    Site Not Available

  • Ospedale Mauriziano Umberto I

    Torino, 10128
    Italy

    Site Not Available

  • Ospedale Mauriziano Umberto I

    Torino 8980539, 10128
    Italy

    Site Not Available

  • Amsterdam UMC (AMC)

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC
    Netherlands

    Site Not Available

  • Amsterdam UMC (AMC)

    Amsterdam 2759794, 1105 AZ
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam 2759794, 1091 AC
    Netherlands

    Site Not Available

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Geleen, 6162 BG
    Netherlands

    Site Not Available

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Geleen 2755616, 6162 BG
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen 2750053, 6525 GA
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Franciscus Gasthuis

    Rotterdam, 3045 PM
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam 2747891, 3015 GD
    Netherlands

    Site Not Available

  • Franciscus Gasthuis

    Rotterdam 2747891, 3045 PM
    Netherlands

    Site Not Available

  • ETZ Elisabeth

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

  • ETZ Elisabeth

    Tilburg 2746301, 5022 GC
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • UMC Utrecht

    Utrecht 2745912, 3584 CX
    Netherlands

    Site Not Available

  • Nordlandsykehuset

    Bodø, 8092
    Norway

    Site Not Available

  • Nordlandsykehuset

    Bodø 3160881, 8092
    Norway

    Site Not Available

  • Akershus Universitetssykehus

    Lørenskog, 1478
    Norway

    Site Not Available

  • Bærum Hospital , Gjettum

    Oslo, 1346
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo, 0424
    Norway

    Site Not Available

  • Bærum Hospital , Gjettum

    Oslo 3143244, 1346
    Norway

    Site Not Available

  • Oslo University Hospital

    Oslo 3143244, 0424
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Norge

    Tromsø, 9019
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Norge

    Tromsø 3133895, 9019
    Norway

    Site Not Available

  • St. Olav's University Hospital

    Trondheim, 7030
    Norway

    Site Not Available

  • St. Olav's University Hospital

    Trondheim 3133880, 7030
    Norway

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia 08025
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, Catalonia 3336901 08025
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona 3129028, Spain 08916
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona, C/ Villarroel, 170

    Barcelona 3128760, Spain 08036
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria 2515270, Spain 35012
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma de Mallorca 2512989, Spain 07120
    Spain

    Site Not Available

  • Hospital Universitario de Santiago de Compostela

    Santiago de Compostela 3109642, Spain 15706
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona, C/ Villarroel, 170

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35012
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120
    Spain

    Site Not Available

  • Hospital Universitario de Santiago de Compostela

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • The Ulster Hospital

    Belfast, BT161RH
    United Kingdom

    Site Not Available

  • The Ulster Hospital

    Belfast 2655984, BT161RH
    United Kingdom

    Site Not Available

  • Bury Care Organisation

    Bury, BL97TD
    United Kingdom

    Site Not Available

  • Bury Care Organisation

    Bury 2654187, BL97TD
    United Kingdom

    Site Not Available

  • Royal Devon University Healthcare NHS Foundation trust

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Royal Devon University Healthcare NHS Foundation trust

    Exeter 2649808, EX2 5DW
    United Kingdom

    Site Not Available

  • Glasgow Royal Infirmary

    Glasgow, G40SF
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, G514TF
    United Kingdom

    Site Not Available

  • Glasgow Royal Infirmary

    Glasgow 2648579, G40SF
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow 2648579, G514TF
    United Kingdom

    Site Not Available

  • St George's Hospital

    London, SW170QT
    United Kingdom

    Site Not Available

  • St Mark's Hospital, Central Middlesex, Acton Lane

    London, NW10 7NS
    United Kingdom

    Site Not Available

  • St George's Hospital

    London 2643743, SW170QT
    United Kingdom

    Site Not Available

  • St Mark's Hospital, Central Middlesex, Acton Lane

    London 2643743, NW10 7NS
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich, NR47UY
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich 2641181, NR47UY
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford, OX39DU
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford 2640729, OX39DU
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton 2637487, SO16 6YD
    United Kingdom

    Site Not Available

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