Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)
GALOCEAN
A Prospective, Non-interventional, Multi-country Cohort Study of the Effectiveness and Safety of Filgotinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis
2 other identifiers
observational
509
10 countries
81
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
December 24, 2025
December 1, 2025
4.5 years
April 5, 2023
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Persistence Rate at week 52.
The persistence rate is defined as the percentage of participants who have continued filgotinib treatment since initiation.
Week 52
Secondary Outcomes (8)
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 Urgency Numeric Rating Scale (NRS)
Baseline, Weeks 10, 24, 52
- +3 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
The study population will consist of participants aged 18 years or older with moderately or severely active UC as judged by the physician and starting filgotinib treatment. Participants are enrolled across around 10 countries in Europe, including the United Kingdom.
You may qualify if:
- \. 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.
You may not qualify if:
- Participant is diagnosed with Crohn's disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alfasigma S.p.A.lead
Study Sites (81)
LKH - Universitätsklinikum Graz
Graz, 8036, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020, Austria
KH der Barmherzigen Brüder St.Veit an der Glan
Sankt Veit an der Glan, 9300, Austria
AKH - Medizinische Universität Wien
Vienna, 1090, Austria
Imeldaziekenhuis
Bonheiden, 2820, Belgium
CHU Saint-Pierre
Brussels, 1000, Belgium
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, 1070, Belgium
UZA
Edegem, 2650, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
AZ Sint-Lucas
Ghent, 9000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Sint-Franciscus ziekenhuis
Heusden-Zolder, 3550, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liège
Liège, 4000, Belgium
Clinique CHC MontLégia
Liège, 4000, Belgium
AZ Damiaan
Ostend, 8400, Belgium
CHU Amiens - Hopital Sud
Amiens, 80000, France
Hôpital Jean Minjoz
Besançon, 25000, France
Clinique Abroise Paré
Clichy, 92200, France
CHU de Grenoble - Hôpital Nord
Grenoble, 38043, France
CHU Lille - Hôpital Claude Huriez
Lille, 59000, France
CHU Montpellier- Hôpital Saint Eloi
Montpellier, 34090, France
CHRU de Nancy
Nancy, 54000, France
CHU Nantes - Hôtel Dieu
Nantes, 44093, France
Hôpital Saint-Louis
Paris, 75010, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, 42055, France
Hôpital Rangueil
Toulouse, 31059, France
Synesis GmbH
Grünwald, Bavaria, 82031, Germany
Klinikum St. Marien Amberg
Amberg, 92224, Germany
Medizinisches Versorgungszentrum Dachau
Dachau, 85221, Germany
Fachinternistische Schwerpunktpraxis
Hamburg, 22041, Germany
Praxis fur Gastroenterologie
Heidelberg, 69115, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitätsklinikum Leipzig AöR
Leipzig, 04103, Germany
Gastro Campus Research GbR
Münster, 48159, Germany
Magen-Darm-Zentrum Remscheid
Remscheid, 42859, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Cork University Hospital
Cork, T12 DFK4, Ireland
St Vincent's University Hospital
Dublin, D04 T6F4, Ireland
Beaumont Hospital
Dublin, D09 A0HK, Ireland
Azienda Ospedaliera Saverio De Bellis - Castellana Grotte
Bari, Italia, 70013, Italy
IRCCS Ospedale San Raffaele ,Via Olgettina 60
Milan, Italia, 20132, Italy
Azienda Ospedaliero Universitaria Pisana - Cisanello
Pisa, Italia, 56124, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
ASST Fatebenefratelli Sacco
Milan, 20157, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, 37024, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
Ospedale Mauriziano Umberto I
Torino, 10128, Italy
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC, Netherlands
Amsterdam UMC (AMC)
Amsterdam, 1105 AZ, Netherlands
Zuyderland Medisch Centrum - Sittard-Geleen
Geleen, 6162 BG, Netherlands
Radboud UMC
Nijmegen, 6525 GA, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Franciscus Gasthuis
Rotterdam, 3045 PM, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Nordlandsykehuset
Bodø, 8092, Norway
Akershus Universitetssykehus
Lørenskog, 1478, Norway
Oslo University Hospital
Oslo, 0424, Norway
Bærum Hospital , Gjettum
Oslo, 1346, Norway
Universitetssykehuset Nord-Norge
Tromsø, 9019, Norway
St. Olav's University Hospital
Trondheim, 7030, Norway
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916, Spain
Hospital Clinic de Barcelona, C/ Villarroel, 170
Barcelona, Spain, 08036, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain, 35012, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain, 07120, Spain
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, Spain, 15706, Spain
The Ulster Hospital
Belfast, BT161RH, United Kingdom
Bury Care Organisation
Bury, BL97TD, United Kingdom
Royal Devon University Healthcare NHS Foundation trust
Exeter, EX2 5DW, United Kingdom
Glasgow Royal Infirmary
Glasgow, G40SF, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G514TF, United Kingdom
St Mark's Hospital, Central Middlesex, Acton Lane
London, NW10 7NS, United Kingdom
St George's Hospital
London, SW170QT, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR47UY, United Kingdom
John Radcliffe Hospital
Oxford, OX39DU, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alfasigma Study Director
Alfasigma S.p.A.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2023
First Posted
April 18, 2023
Study Start
June 12, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share