Rheumatoid Arthritis Clinical Trial
— FILOSOPHYOfficial title:
A Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving Filgotinib
| Verified date | May 2024 |
| Source | Galapagos NV |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 1304 |
| Est. completion date | July 2025 |
| Est. primary completion date | July 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients aged = 18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local standard of care and product label for the first time. - Patients must be willing and able to use an electronic device to complete the study patient-reported outcome (PRO). 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Algemeen Stedelijk Ziekenhuis | Aalst | |
| Belgium | Imelda VZW | Bonheiden | |
| Belgium | AZ Sint-Jan Brugge-Oostende | Brugge | |
| Belgium | Hôpital Erasme | Brussel | |
| Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
| Belgium | Grand Hôpital de Charleroi asbl | Charleroi | |
| Belgium | UZ Antwerpen | Edegem | |
| Belgium | Reumacentrum Genk | Genk | |
| Belgium | Reumaclinic Genk | Genk | |
| Belgium | AZ Maria Middelares | Gent | |
| Belgium | Reuma Instituut | Hasselt | |
| Belgium | UZ Leuven | Leuven | |
| Belgium | CHU de Liège | Liège | |
| Belgium | ZNA Jan Palfijn | Merksem | |
| Belgium | CHU UCL Namur asbl - Site Godinne | Yvoir | |
| Germany | Rheumazentrum Kupka | Altenburg | |
| Germany | Praxis für Rheumatologie - Amberg | Amberg | |
| Germany | Rheumatology Center Prof. Neeck | Bad Doberan | |
| Germany | Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie | Berlin | |
| Germany | Rheumapraxis am Schlachtensee | Berlin | |
| Germany | Rheumapraxis Mexikoplatz | Berlin | |
| Germany | Rheumatologische Schwerpunktpraxis | Berlin | |
| Germany | Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin | Demmin | |
| Germany | Rheumatologisches MVZ Dresden | Dresden | |
| Germany | Universitatsklinikum Dusseldorf | Düsseldorf | |
| Germany | Praxis Dilltal | Ehringshausen | |
| Germany | MVZ Ambulantes Rheumazentrum Erfurt | Erfurt | |
| Germany | Universitätsmedizin Greifswald, Abteilung Innere Medizin A | Greifswald | |
| Germany | Internistisch-Rheumatologische Arztpraxis | Halle | |
| Germany | Praxis für Rheumatologie | Hamburg | |
| Germany | Rheumatologie im Struenseehaus | Hamburg | |
| Germany | Rheumazentrum Ruhrgebiet | Herne | |
| Germany | Praxis für Internistische Rheumatologie | Leipzig | |
| Germany | Rheumapraxis | Leipzig | |
| Germany | Rheumatologische Facharztpraxis | Magdeburg | |
| Germany | Rheumapraxis | Mansfeld | |
| Germany | Praxis far Rheumatologie, Gastroenterologie und Innere Medizin | München | |
| Germany | Rheumatologisches Praxiszentrum St. Bonifatius | München | |
| Germany | Rheumapraxis | Neubrandenburg | |
| Germany | Medizinischen Versorgungszentrums für Rheumatologie | Planegg | |
| Germany | Rheumahaus - GbR | Potsdam | |
| Germany | Rheumazentrum Ratingen | Ratingen | |
| Germany | Rheumatologisch-immunologische Arztpraxis | Templin | |
| Germany | Krankenhaus der Barmherzigen Brüder | Trier | |
| Germany | Klinikverbund St. Antonius und St. Josef GmbH | Wuppertal | |
| Italy | A.O.U. Policlinico di Bari | Bari | |
| Italy | ASST degli Spedali Civili di Brescia | Brescia | |
| Italy | AOU Policlinico Vittorio Emanuele-PO San Marco | Catania | |
| Italy | A.O.U. di Ferrara - Nuovo ospedale S.Anna | Ferrara | |
| Italy | S.C. Reumatologia Asl3 | Genova | |
| Italy | ASST Gaetano Pini CTO | Milano | |
| Italy | Azienda Osp. Univ. Luigi Vanvitelli | Napoli | |
| Italy | Policlinico Gemelli | Roma | |
| Italy | Policlinico Umberto I Univ. Sapienza | Roma | |
| Italy | Azienda Ospedaliera Universitaria Integrata Di Verona | Verona | |
| Netherlands | Noordwest Ziekenhuisgroep | Alkmaar | |
| Netherlands | READE | Amsterdam | |
| Netherlands | Hagaziekenhuis | Den Haag | |
| Netherlands | Medisch Spectrum Twente | Enschede | |
| Netherlands | Reumazorg Zuid West | Goes | |
| Netherlands | Elkerliek Ziekenhuis | Helmond | |
| Netherlands | Medisch Centrum Leeuwarden | Leeuwarden | |
| Netherlands | Erasmus MC | Rotterdam | |
| Netherlands | Sint Maartenskliniek | Ubbergen | |
| Spain | Complexo Hospitalario Universitario | A Coruña | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital Universitario Vall d'Hebrón | Barcelona | |
| Spain | C.H. Regional Reina Sofia | Córdoba | |
| Spain | Hospital de Mérida | Mérida | |
| Spain | Hospital Universitario Virgen de La Arrixaca | Murcia | |
| Spain | Hospital Universitari Son Espases | Palma | |
| Spain | Hospital Provincial de Pontevedra | Pontevedra | |
| Spain | Hospital Universitario Hospiten Rambla de Tenerife | Santa Cruz De Tenerife | |
| Spain | Hospital Clinico Universitario | Santiago De Compostela | |
| Spain | Hospital Universitario Virgen del Rocio - PPDS | Sevilla | |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| United Kingdom | Aberdeen Royal Infirmary PPDS | Aberdeen | |
| United Kingdom | Royal Free NHS Foundation Trust | Barnet | |
| United Kingdom | University Hospital Coventry | Coventry | |
| United Kingdom | Doncaster Royal Infirmary | Doncaster | |
| United Kingdom | Ninewells Hospital - PPDS | Dundee | |
| United Kingdom | Western General Hospital Edinburgh - PPDS | Edinburgh | |
| United Kingdom | Royal Liverpool University Hospital | Liverpool | |
| United Kingdom | Guy's and St Thomas NHS Foundation Trust - Guy's Hospital | London | |
| United Kingdom | Kings College Hospital | London | |
| United Kingdom | Luton and Dunstable Hospital | Luton | |
| United Kingdom | Freeman Hospital | Newcastle | |
| United Kingdom | Royal Berkshire Hospital NHS Foundation Trust | Reading | |
| United Kingdom | York Teaching Hospitals NHS Foundation Trust | York |
| Lead Sponsor | Collaborator |
|---|---|
| Galapagos NV |
Belgium, Germany, Italy, Netherlands, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | patients' assessment of pain, Visual Analogue Scale (Pain VAS) | Up to 24 months | ||
| Secondary | patients' assessment of fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F score) | Up to 24 months | ||
| Secondary | patients' assessment of Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) | Up to 24 months | ||
| Secondary | medication adherence, compliance questionnaire rheumatology 19 (CQR19) | Up to 24 months | ||
| Secondary | medication adherence, compliance questionnaire rheumatology 5 (CQR5) | Up to 24 months | ||
| Secondary | Number of adverse events and serious adverse events | Up to 24 months | ||
| Secondary | patients' assessment of Rheumatoid Arthritis Impact of Disease (RAID) | Up to 24 months |
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