Ulcerative Colitis Clinical Trial
— GALOCEANOfficial title:
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
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.
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | LKH - Universitätsklinikum Graz | Graz | |
| Austria | Klinikum Klagenfurt am Wörthersee | Klagenfurt am Wörthersee | |
| Austria | KH der Barmherzigen Brüder St.Veit an der Glan | St. Veit an der Glan | |
| Austria | AKH - Medizinische Universität Wien | Wien | |
| Belgium | Imeldaziekenhuis | Bonheiden | |
| Belgium | CHU Saint-Pierre | Brussels | |
| Belgium | Cliniques Universitaires de Bruxelles Hopital Erasme | Bruxelles | |
| Belgium | UZA | Edegem | |
| Belgium | AZ Maria Middelares | Gent | |
| Belgium | AZ Sint-Lucas | Gent | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | Sint-Franciscus ziekenhuis | Heusden-Zolder | |
| Belgium | UZ Leuven | Leuven | |
| Belgium | CHU de Liège | Liège | |
| Belgium | Clinique CHC MontLégia | Liège | |
| Belgium | AZ Damiaan | Oostende | |
| France | CHU Amiens - Hopital Sud | Amiens | |
| France | Hôpital Jean Minjoz | Besançon | |
| France | Clinique Abroise Paré | Clichy | |
| France | CHU de Grenoble - Hôpital Nord | Grenoble Cedex 09 | |
| 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-Étienne | |
| France | Hôpital Rangueil | Toulouse | |
| Germany | 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 | St. Marienkrankenhaus | Ludwigshafen am Rhein | |
| Germany | Gastro Campus Research GbR | Münster | |
| Germany | MVZ Internisten am Ring | Nürnberg | |
| Germany | Magen-Darm-Zentrum Remscheid | Remscheid | |
| Germany | Universitätsklinikum Tübingen | Tübingen | |
| Ireland | Cork University Hospital | Cork | |
| Ireland | St Vincent's University Hospital | Dublin | |
| Italy | ASST Fatebenefratelli Sacco | Milano | |
| Italy | IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | |
| Italy | Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello | Palermo | |
| Italy | IRCCS Istituto Clinico Humanitas | Rozzano | |
| Italy | Ospedale Mauriziano Umberto I | Torino | |
| Netherlands | Amsterdam UMC (AMC) | Amsterdam | |
| Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
| Netherlands | Zuyderland Medisch Centrum - Sittard-Geleen | Geleen | |
| Netherlands | Radboud UMC | Nijmegen | |
| Netherlands | Erasmus MC | Rotterdam | |
| Netherlands | Franciscus Gasthuis | Rotterdam | |
| Netherlands | ETZ Elisabeth | Tilburg | |
| Netherlands | UMC Utrecht | Utrecht | |
| Norway | Nordlandsykehuset | Bodø | |
| Norway | Akershus Universitetssykehus | Lørenskog | |
| Norway | Bærum Hospital , Gjettum | Oslo | |
| Norway | Oslo University Hospital | Oslo | |
| Norway | Universitetssykehuset Nord-Norge | Tromsø | |
| Norway | St. Olav's University Hospital | Trondheim | |
| United Kingdom | The Ulster Hospital | Belfast | |
| United Kingdom | Bury Care Organisation | Bury | |
| United Kingdom | Royal Devon University Healthcare NHS Foundation trust | Exeter | |
| United Kingdom | Glasgow Royal Infirmary | Glasgow | |
| United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
| United Kingdom | St George's Hospital | London | |
| United Kingdom | Norfolk and Norwich University Hospital | Norwich | |
| United Kingdom | John Radcliffe Hospital | Oxford | |
| United Kingdom | Southampton General Hospital | Southampton |
| Lead Sponsor | Collaborator |
|---|---|
| Galapagos NV |
Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Norway, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Treatment Persistence Rate at weeks 10 and 24 | Weeks 10, 24 | ||
| Secondary | Clinical Response Rate | Weeks 10, 24, 52 | ||
| Secondary | Clinical Remission Rate | Weeks 10, 24, 52 | ||
| Secondary | 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 | ||
| Secondary | Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS) | Baseline, Weeks 10, 24, 52 | ||
| Secondary | Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) | Baseline, Weeks 10, 24, 52 | ||
| Secondary | Number of Participants with Adverse Events (AEs) | Up to 52 Weeks | ||
| Secondary | Number of Participants with Serious Adverse Events (SAEs) | Up To 52 Weeks |
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