Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis
- Registration Number
- NCT04871919
- Lead Sponsor
- Alfasigma S.p.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1304
- 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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Filgotinib 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
- Primary Outcome Measures
Name Time Method Treatment persistence rates Up to 24 months To evaluate the treatment persistence rate at 24 months, defined as the rate of patients continuing to receive filgotinib 24 months from treatment initiation.
- Secondary Outcome Measures
Name Time Method 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) 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.
Trial Locations
- Locations (87)
READE
🇳🇱Amsterdam, Netherlands
Universitatsklinikum Dusseldorf
🇩🇪Düsseldorf, Germany
AOU Policlinico Vittorio Emanuele-PO San Marco
🇮🇹Catania, Italy
Algemeen Stedelijk Ziekenhuis
🇧🇪Aalst, Belgium
AZ Sint-Jan Brugge-Oostende
🇧🇪Brugge, Belgium
Imelda VZW
🇧🇪Bonheiden, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Hôpital Erasme
🇧🇪Brussel, Belgium
Grand Hôpital de Charleroi asbl
🇧🇪Charleroi, Belgium
Reumacentrum Genk
🇧🇪Genk, Belgium
Reumaclinic Genk
🇧🇪Genk, Belgium
UZ Antwerpen
🇧🇪Edegem, 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, Belgium
Rheumazentrum Kupka
🇩🇪Altenburg, Germany
Praxis für Rheumatologie - Amberg
🇩🇪Amberg, Germany
Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie
🇩🇪Berlin, Germany
Rheumatologische Schwerpunktpraxis
🇩🇪Berlin, Germany
Rheumapraxis am Schlachtensee
🇩🇪Berlin, Germany
Rheumapraxis Mexikoplatz
🇩🇪Berlin, Germany
Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin
🇩🇪Demmin, Germany
Praxis Dilltal
🇩🇪Ehringshausen, Germany
MVZ Ambulantes Rheumazentrum Erfurt
🇩🇪Erfurt, Germany
Universitätsmedizin Greifswald, Abteilung Innere Medizin A
🇩🇪Greifswald, Germany
Internistisch-Rheumatologische Arztpraxis
🇩🇪Halle, Germany
Rheumatologie im Struenseehaus
🇩🇪Hamburg, Germany
Rheumazentrum Ruhrgebiet
🇩🇪Herne, Germany
Rheumapraxis
🇩🇪Neubrandenburg, Germany
Rheumatologische Facharztpraxis
🇩🇪Magdeburg, Germany
Praxis für Internistische Rheumatologie
🇩🇪Leipzig, Germany
Rheumatologisches Praxiszentrum St. Bonifatius
🇩🇪München, Germany
Praxis far Rheumatologie, Gastroenterologie und Innere Medizin
🇩🇪München, Germany
Rheumahaus - GbR
🇩🇪Potsdam, Germany
Rheumatologisch-immunologische Arztpraxis
🇩🇪Templin, Germany
A.O.U. Policlinico di Bari
🇮🇹Bari, Italy
Krankenhaus der Barmherzigen Brüder
🇩🇪Trier, Germany
Hospital Universitario Vall d'Hebrón
🇪🇸Barcelona, Spain
ASST degli Spedali Civili di Brescia
🇮🇹Brescia, 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, Italy
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Hagaziekenhuis
🇳🇱Den Haag, Netherlands
Elkerliek Ziekenhuis
🇳🇱Helmond, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Reumazorg Zuid West
🇳🇱Goes, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
Sint Maartenskliniek
🇳🇱Ubbergen, Netherlands
Hospital del Mar
🇪🇸Barcelona, Spain
Complexo Hospitalario Universitario
🇪🇸A Coruña, Spain
Hospital Universitario Virgen de La Arrixaca
🇪🇸Murcia, Spain
Hospital de Mérida
🇪🇸Mérida, 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
Rheumatology Center Prof. Neeck
🇩🇪Bad Doberan, Germany
Praxis für Rheumatologie
🇩🇪Hamburg, Germany
Rheumatologisches MVZ Dresden
🇩🇪Dresden, Germany
Medizinischen Versorgungszentrums für Rheumatologie
🇩🇪Planegg, Germany
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocio - PPDS
🇪🇸Sevilla, Spain
Aberdeen Royal Infirmary PPDS
🇬🇧Aberdeen, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Royal Free NHS Foundation Trust
🇬🇧Barnet, United Kingdom
Ninewells Hospital - PPDS
🇬🇧Dundee, United Kingdom
Western General Hospital Edinburgh - PPDS
🇬🇧Edinburgh, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, 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, United Kingdom
Rheumazentrum Ratingen
🇩🇪Ratingen, Germany
C.H. Regional Reina Sofia
🇪🇸Córdoba, Spain
Klinikverbund St. Antonius und St. Josef GmbH
🇩🇪Wuppertal, Germany
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom