Clinical trial NCT05817942: Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Keywords: filgotinib
safety
efficacy
Lead sponsor: Alfasigma S.p.A.
Sponsor class: INDUSTRY
First posted: 2023-04-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Persistence Rate at week 52.
timeFrame: Week 52
Secondary outcomes:
measure: Treatment Persistence Rate at weeks 10, 24, 76 and 104
timeFrame: Weeks 10, 24, 76 and 104
measure: Clinical Response Rate
timeFrame: Weeks 10, 24, 52, 76 and 104
measure: Clinical Remission Rate
timeFrame: Weeks 10, 24, 52, 76 and 104
measure: Change from Baseline in Health-Related Quality of Life (HRQoL) as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
timeFrame: Baseline, Weeks 10, 24, 52, 76 and 104
measure: Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS)
timeFrame: Baseline, Weeks 10, 24, 52
measure: Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F)
timeFrame: Baseline, Weeks 10, 24, 52, 76 and 104
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 104 Weeks
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up To 104 Weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH - Universitätsklinikum Graz
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: St. Veit an der Glan
country: Austria
facility: KH der Barmherzigen Brüder St.Veit an der Glan
city: Wien
country: Austria
facility: AKH - Medizinische Universität Wien
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brussels
country: Belgium
facility: CHU Saint-Pierre
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires de Bruxelles Hopital Erasme
city: Edegem
country: Belgium
facility: UZA
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Heusden-Zolder
country: Belgium
facility: Sint-Franciscus ziekenhuis
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liège
city: Liège
country: Belgium
facility: Clinique CHC MontLégia
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Amiens
country: France
facility: CHU Amiens - Hopital Sud
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Clichy
country: France
facility: Clinique Abroise Paré
city: Grenoble Cedex 09
country: France
facility: CHU de Grenoble - Hôpital Nord
city: Lille
country: France
facility: CHU Lille - Hôpital Claude Huriez
city: Montpellier
country: France
facility: CHU Montpellier- Hôpital Saint Eloi
city: Nancy
country: France
facility: CHRU de Nancy
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: CHU Bordeaux - Hôpital Haut-Lévêque
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint-Étienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Grünwald
country: Germany
facility: Synesis GmbH
state: Bavaria
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg
city: Dachau
country: Germany
facility: Medizinisches Versorgungszentrum Dachau
city: Hamburg
country: Germany
facility: Fachinternistische Schwerpunktpraxis
city: Heidelberg
country: Germany
facility: Praxis fur Gastroenterologie
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Ludwigshafen am Rhein
country: Germany
facility: St. Marienkrankenhaus
city: Münster
country: Germany
facility: Gastro Campus Research GbR
city: Nürnberg
country: Germany
facility: MVZ Internisten am Ring
city: Remscheid
country: Germany
facility: Magen-Darm-Zentrum Remscheid
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Bari
country: Italy
facility: Azienda Ospedaliera Saverio De Bellis - Castellana Grotte
state: Italia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele ,Via Olgettina 60
state: Italia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Cisanello
state: Italia
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Negrar
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC (AMC)
city: Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard-Geleen
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Bodø
country: Norway
facility: Nordlandsykehuset
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: Bærum Hospital , Gjettum
city: Tromsø
country: Norway
facility: Universitetssykehuset Nord-Norge
city: Trondheim
country: Norway
facility: St. Olav's University Hospital
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona, C/ Villarroel, 170
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
city: Belfast
country: United Kingdom
facility: The Ulster Hospital
city: Bury
country: United Kingdom
facility: Bury Care Organisation
city: Exeter
country: United Kingdom
facility: Royal Devon University Healthcare NHS Foundation trust
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: London
country: United Kingdom
facility: St Mark's Hospital, Central Middlesex, Acton Lane
city: London
country: United Kingdom
facility: St George's Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Alfasigma S.p.A.
name: Alfasigma Study Director
role: STUDY_DIRECTOR
References: