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| ID | Type | Description | Link |
|---|---|---|---|
| 48323 | Other Identifier | HMA-EMA Catalogues |
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An observational study to describe the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active rheumatoid arthritis (RA) receiving filgotinib in real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib | Individuals will receive treatment for moderate to severe active rheumatoid arthritis with at least one dose of filgotinib in accordance with the product label |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Tablets are administered in accordance with the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment persistence rates | To evaluate the treatment persistence rate at 24 months, defined as the rate of patients continuing to receive filgotinib 24 months from treatment initiation. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| patients' assessment of pain, Visual Analogue Scale (Pain VAS) | Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months. | |
| patients' assessment of fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F score) |
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Inclusion Criteria:
Exclusion Criteria:
- Participation in any other interventional or non-interventional study without prior approval from the Medical Monitor. This does not preclude inclusion of patients enrolled to national registries.
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The study population will consist of patients aged ≥ 18 years with moderate to severe active RA receiving filgotinib who will be enrolled across participating countries within Europe.
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| Name | Affiliation | Role |
|---|---|---|
| Alfasigma Study Director | Alfasigma S.p.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Stedelijk Ziekenhuis | Aalst | 9300 | Belgium | |||
| Imelda VZW |
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| Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months. |
| patients' assessment of Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) | Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months. |
| medication adherence, compliance questionnaire rheumatology 19 (CQR19) | Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months. |
| medication adherence, compliance questionnaire rheumatology 5 (CQR5) | Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months. |
| Number of adverse events and serious adverse events | Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months. |
| patients' assessment of Rheumatoid Arthritis Impact of Disease (RAID) | Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months. |
| Bonheiden |
| 2820 |
| Belgium |
| AZ Sint-Jan Brugge-Oostende | Bruges | 8000 | Belgium |
| Hôpital Erasme | Brussels | 1070 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| Grand Hôpital de Charleroi asbl | Charleroi | 6000 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Reumacentrum Genk | Genk | 3600 | Belgium |
| Reumaclinic Genk | Genk | 3600 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| Reuma Instituut | Hasselt | 3500 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| ZNA Jan Palfijn | Merksem | 2170 | Belgium |
| CHU UCL Namur asbl - Site Godinne | Yvoir | 5530 | Belgium |
| Rheumazentrum Kupka | Altenburg | 4600 | Germany |
| Praxis für Rheumatologie - Amberg | Amberg | 92224 | Germany |
| Rheumatology Center Prof. Neeck | Bad Doberan | 18209 | Germany |
| Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie | Berlin | 10117 | Germany |
| Rheumatologische Schwerpunktpraxis | Berlin | 12161 | Germany |
| Rheumapraxis am Schlachtensee | Berlin | 14129 | Germany |
| Rheumapraxis Mexikoplatz | Berlin | 14163 | Germany |
| Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin | Demmin | 17109 | Germany |
| Rheumatologisches MVZ Dresden | Dresden | 01109 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Praxis Dilltal | Ehringshausen | 35630 | Germany |
| MVZ Ambulantes Rheumazentrum Erfurt | Erfurt | 99096 | Germany |
| Universitätsmedizin Greifswald, Abteilung Innere Medizin A | Greifswald | 17475 | Germany |
| Internistisch-Rheumatologische Arztpraxis | Halle | 06128 | Germany |
| Rheumatologie im Struenseehaus | Hamburg | 22767 | Germany |
| Praxis für Rheumatologie | Hamburg | 2291 | Germany |
| Rheumazentrum Ruhrgebiet | Herne | 44649 | Germany |
| Rheumapraxis | Leipzig | 04109 | Germany |
| Praxis für Internistische Rheumatologie | Leipzig | 04129 | Germany |
| Rheumatologische Facharztpraxis | Magdeburg | 39104 | Germany |
| Rheumapraxis | Mansfeld | 6343 | Germany |
| Praxis far Rheumatologie, Gastroenterologie und Innere Medizin | München | 80639 | Germany |
| Rheumatologisches Praxiszentrum St. Bonifatius | München | 81541 | Germany |
| Rheumapraxis | Neubrandenburg | 17033 | Germany |
| Medizinischen Versorgungszentrums für Rheumatologie | Planegg | 82152 | Germany |
| Rheumahaus - GbR | Potsdam | 14469 | Germany |
| Rheumazentrum Ratingen | Ratingen | 40878 | Germany |
| Rheumatologisch-immunologische Arztpraxis | Templin | 17268 | Germany |
| Krankenhaus der Barmherzigen Brüder | Trier | 54292 | Germany |
| Klinikverbund St. Antonius und St. Josef GmbH | Wuppertal | 42283 | Germany |
| A.O.U. Policlinico di Bari | Bari | 70124 | Italy |
| ASST degli Spedali Civili di Brescia | Brescia | 25123 | Italy |
| AOU Policlinico Vittorio Emanuele-PO San Marco | Catania | 95121 | Italy |
| A.O.U. di Ferrara - Nuovo ospedale S.Anna | Ferrara | 44124 | Italy |
| S.C. Reumatologia Asl3 | Genova | 16125 | Italy |
| ASST Gaetano Pini CTO | Milan | 20122 | Italy |
| Azienda Osp. Univ. Luigi Vanvitelli | Naples | 80100 | Italy |
| Policlinico Umberto I Univ. Sapienza | Roma | 00161 | Italy |
| Policlinico Gemelli | Roma | 00168 | Italy |
| Azienda Ospedaliera Universitaria Integrata Di Verona | Verona | 37126 | Italy |
| Noordwest Ziekenhuisgroep | Alkmaar | 1815 JD | Netherlands |
| READE | Amsterdam | 1054 HW | Netherlands |
| Medisch Spectrum Twente | Enschede | 7512 KZ | Netherlands |
| Reumazorg Zuid West | Goes | 4462 EV | Netherlands |
| Elkerliek Ziekenhuis | Helmond | 5707 HA | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| Erasmus MC | Rotterdam | 3015 GD | Netherlands |
| Hagaziekenhuis | The Hague | 2545 AA | Netherlands |
| Sint Maartenskliniek | Ubbergen | 6574 NA | Netherlands |
| Complexo Hospitalario Universitario | A Coruña | 15006 | Spain |
| Hospital del Mar | Barcelona | 8003 | Spain |
| Hospital Universitario Vall d'Hebrón | Barcelona | 8025 | Spain |
| C.H. Regional Reina Sofia | Córdoba | 14004 | Spain |
| Hospital de Mérida | Mérida | 06800 | Spain |
| Hospital Universitario Virgen de La Arrixaca | Murcia | 30120 | Spain |
| Hospital Universitari Son Espases | Palma | 07120 | Spain |
| Hospital Provincial de Pontevedra | Pontevedra | 36001 | Spain |
| Hospital Universitario Hospiten Rambla de Tenerife | Santa Cruz de Tenerife | 38003 | Spain |
| Hospital Clinico Universitario | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Virgen del Rocio - PPDS | Seville | 41013 | Spain |
| Aberdeen Royal Infirmary PPDS | Aberdeen | AB25 2ZA | United Kingdom |
| Royal Free NHS Foundation Trust | Barnet | EN5 3DJ | United Kingdom |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Doncaster Royal Infirmary | Doncaster | DN2 5LT | United Kingdom |
| Ninewells Hospital - PPDS | Dundee | DD1 95Y | United Kingdom |
| Western General Hospital Edinburgh - PPDS | Edinburgh | EH4 2XU | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Guy's and St Thomas NHS Foundation Trust - Guy's Hospital | London | SE5 9RS | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Luton and Dunstable Hospital | Luton | LU4 0DZ | United Kingdom |
| Freeman Hospital | Newcastle | NE1 4LP | United Kingdom |
| Royal Berkshire Hospital NHS Foundation Trust | Reading | RG1 5AN | United Kingdom |
| York Teaching Hospitals NHS Foundation Trust | York | YO31 8HE | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C584571 | GLPG0634 |
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