Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)
- Registration Number
- NCT05817942
- Lead Sponsor
- Alfasigma S.p.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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.
- Participant is diagnosed with Crohn's disease.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm A: Filgotinib Filgotinib Participants diagnosed with moderately or severely active UC taking filgotinib according to local treatment guidelines or routine clinical practice and product information.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Number of Participants with Serious Adverse Events (SAEs) Up To 104 Weeks Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS) Baseline, Weeks 10, 24, 52 Number of Participants with Adverse Events (AEs) Up to 104 Weeks 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 Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) Baseline, Weeks 10, 24, 52, 76 and 104
Trial Locations
- Locations (81)
Synesis GmbH
🇩🇪Grünwald, Bavaria, Germany
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, France
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
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Ospedale Mauriziano Umberto I
🇮🇹Torino, Italy
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Amsterdam UMC (AMC)
🇳🇱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, Netherlands
Nordlandsykehuset
🇳🇴Bodø, Norway
Akershus Universitetssykehus
🇳🇴Lørenskog, Norway
Oslo University Hospital
🇳🇴Oslo, Norway
Bærum Hospital , Gjettum
🇳🇴Oslo, Norway
Universitetssykehuset Nord-Norge
🇳🇴Tromsø, Norway
St. Olav's University Hospital
🇳🇴Trondheim, Norway
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Catalonia, Spain
Hospital Clinic de Barcelona, C/ Villarroel, 170
🇪🇸Barcelona, Spain
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 Mark's Hospital, Central Middlesex, Acton Lane
🇬🇧London, 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, United Kingdom
Azienda Ospedaliera Saverio De Bellis - Castellana Grotte
🇮🇹Bari, Italia, Italy
Azienda Ospedaliero Universitaria Pisana - Cisanello
🇮🇹Pisa, Italia, Italy
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
🇪🇸Las Palmas de Gran Canaria, Spain
Hospital Universitari Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
CHRU de Nancy
🇫🇷Nancy, France
LKH - Universitätsklinikum Graz
🇦🇹Graz, Austria
CHU Saint-Pierre
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
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, Austria
Imeldaziekenhuis
🇧🇪Bonheiden, Belgium
Cliniques Universitaires de Bruxelles Hopital Erasme
🇧🇪Bruxelles, Belgium
UZA
🇧🇪Edegem, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
AZ Sint-Lucas
🇧🇪Gent, Belgium
Sint-Franciscus ziekenhuis
🇧🇪Heusden-Zolder, Belgium
Clinique CHC MontLégia
🇧🇪Liège, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
AZ Damiaan
🇧🇪Oostende, Belgium
Hôpital Jean Minjoz
🇫🇷Besançon, France
CHU de Liège
🇧🇪Liège, Belgium
CHU Amiens - Hopital Sud
🇫🇷Amiens, 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
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, Germany
Cork University Hospital
🇮🇪Cork, Ireland
St Vincent's University Hospital
🇮🇪Dublin, Ireland
IRCCS Ospedale San Raffaele ,Via Olgettina 60
🇮🇹Milano, Italia, Italy
ASST Fatebenefratelli Sacco
🇮🇹Milano, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
🇮🇹Palermo, Italy