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| ID | Type | Description | Link |
|---|---|---|---|
| 105477 | Other Identifier | HMA-EMA Catalogues |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Jyseleca |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alfasigma Study Director | Alfasigma S.p.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH - Universitätsklinikum Graz | Graz | 8036 | Austria | |||
| Klinikum Klagenfurt am Wörthersee |
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| 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 |
| 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 |
| Number of Participants with Adverse Events (AEs) | Up to 104 Weeks |
| Number of Participants with Serious Adverse Events (SAEs) | Up To 104 Weeks |
| 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 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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