Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis
FILOSOPHY
A Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving Filgotinib
2 other identifiers
observational
1,304
6 countries
89
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Longer than P75 for all trials
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedStudy Start
First participant enrolled
May 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
September 15, 2025
September 1, 2025
7.1 years
April 29, 2021
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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.
- +2 more secondary outcomes
Study Arms (1)
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
Interventions
Tablets are administered in accordance with the product label
Eligibility Criteria
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.
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alfasigma S.p.A.lead
Study Sites (89)
Algemeen Stedelijk Ziekenhuis
Aalst, 9300, Belgium
Imelda VZW
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
Napoli, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alfasigma Study Director
Alfasigma S.p.A.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2021
First Posted
May 4, 2021
Study Start
May 11, 2021
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share