Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis (FILOSOPHY)

September 9, 2025 updated by: Alfasigma S.p.A.

A Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving Filgotinib

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Algemeen Stedelijk Ziekenhuis
      • Bonheiden, Belgium, 2820
        • Imelda VZW
      • Bruges, Belgium, 8000
        • AZ Sint-Jan Brugge-Oostende
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Brussels, Belgium, 1070
        • Hopital Erasme
      • Charleroi, Belgium, 6000
        • Grand Hopital de Charleroi asbl
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Genk, Belgium, 3600
        • ReumaClinic Genk
      • Genk, Belgium, 3600
        • Reumacentrum Genk
      • Ghent, Belgium, 9000
        • AZ Maria Middelares
      • Hasselt, Belgium, 3500
        • Reuma Instituut
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liege
      • Merksem, Belgium, 2170
        • ZNA Jan Palfijn
      • Yvoir, Belgium, 5530
        • CHU UCl Namur asbl - Site Godinne
  • Germany
      • Altenburg, Germany, 4600
        • Rheumazentrum Kupka
      • Amberg, Germany, 92224
        • Praxis für Rheumatologie - Amberg
      • Bad Doberan, Germany, 18209
        • Rheumatology Center Prof. Neeck
      • Berlin, Germany, 12161
        • Rheumatologische Schwerpunktpraxis
      • Berlin, Germany, 10117
        • Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie
      • Berlin, Germany, 14129
        • Rheumapraxis am Schlachtensee
      • Berlin, Germany, 14163
        • Rheumapraxis Mexikoplatz
      • Demmin, Germany, 17109
        • Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin
      • Dresden, Germany, 01109
        • Rheumatologisches MVZ Dresden
      • Düsseldorf, Germany, 40225
        • Universitatsklinikum Dusseldorf
      • Ehringshausen, Germany, 35630
        • Praxis Dilltal
      • Erfurt, Germany, 99096
        • MVZ Ambulantes Rheumazentrum Erfurt
      • Greifswald, Germany, 17475
        • Universitätsmedizin Greifswald, Abteilung Innere Medizin A
      • Halle, Germany, 06128
        • Internistisch-Rheumatologische Arztpraxis
      • Hamburg, Germany, 22767
        • Rheumatologie im Struenseehaus
      • Hamburg, Germany, 2291
        • Praxis für Rheumatologie
      • Herne, Germany, 44649
        • Rheumazentrum Ruhrgebiet
      • Leipzig, Germany, 04109
        • Rheumapraxis
      • Leipzig, Germany, 04129
        • Praxis für Internistische Rheumatologie
      • Magdeburg, Germany, 39104
        • Rheumatologische Facharztpraxis
      • Mansfeld, Germany, 6343
        • Rheumapraxis
      • München, Germany, 80639
        • Praxis far Rheumatologie, Gastroenterologie und Innere Medizin
      • München, Germany, 81541
        • Rheumatologisches Praxiszentrum St. Bonifatius
      • Neubrandenburg, Germany, 17033
        • Rheumapraxis
      • Planegg, Germany, 82152
        • Medizinischen Versorgungszentrums für Rheumatologie
      • Potsdam, Germany, 14469
        • Rheumahaus - GbR
      • Ratingen, Germany, 40878
        • Rheumazentrum Ratingen
      • Templin, Germany, 17268
        • Rheumatologisch-immunologische Arztpraxis
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder
      • Wuppertal, Germany, 42283
        • Klinikverbund St. Antonius und St. Josef GmbH
  • Italy
      • Bari, Italy, 70124
        • A.O.U. Policlinico di Bari
      • Brescia, Italy, 25123
        • Asst Degli Spedali Civili Di Brescia
      • Catania, Italy, 95121
        • AOU Policlinico Vittorio Emanuele-PO San Marco
      • Ferrara, Italy, 44124
        • A.O.U. di Ferrara - Nuovo ospedale S.Anna
      • Genova, Italy, 16125
        • S.C. Reumatologia Asl3
      • Milan, Italy, 20122
        • ASST Gaetano Pini CTO
      • Napoli, Italy, 80100
        • Azienda Osp. Univ. Luigi Vanvitelli
      • Roma, Italy, 00168
        • Policlinico Gemelli
      • Roma, Italy, 00161
        • Policlinico Umberto I Univ. Sapienza
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria Integrata di Verona
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Noordwest Ziekenhuisgroep
      • Amsterdam, Netherlands, 1054 HW
        • Reade
      • Enschede, Netherlands, 7512 KZ
        • Medisch Spectrum Twente
      • Goes, Netherlands, 4462 EV
        • Reumazorg Zuid West
      • Helmond, Netherlands, 5707 HA
        • Elkerliek Ziekenhuis
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
      • The Hague, Netherlands, 2545 AA
        • Hagaziekenhuis
      • Ubbergen, Netherlands, 6574 NA
        • Sint Maartenskliniek
  • Spain
      • A Coruña, Spain, 15006
        • Complexo Hospitalario Universitario
      • Barcelona, Spain, 8003
        • Hospital Del Mar
      • Barcelona, Spain, 8025
        • Hospital Universitario Vall d'Hebron
      • Córdoba, Spain, 14004
        • C.H. Regional Reina Sofia
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de La Arrixaca
      • Mérida, Spain, 06800
        • Hospital de Merida
      • Palma, Spain, 07120
        • Hospital Universitari Son Espases
      • Pontevedra, Spain, 36001
        • Hospital Provincial de Pontevedra
      • Santa Cruz de Tenerife, Spain, 38003
        • Hospital Universitario Hospiten Rambla de Tenerife
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio - PPDS
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZA
        • Aberdeen Royal Infirmary PPDS
      • Barnet, United Kingdom, EN5 3DJ
        • Royal Free NHS Foundation Trust
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Doncaster, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary
      • Dundee, United Kingdom, DD1 95Y
        • Ninewells Hospital - PPDS
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital Edinburgh - PPDS
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, United Kingdom, SE5 9RS
        • Guy's and St Thomas NHS Foundation Trust - Guy's Hospital
      • Luton, United Kingdom, LU4 0DZ
        • Luton and Dunstable Hospital
      • Newcastle, United Kingdom, NE1 4LP
        • Freeman Hospital
      • Reading, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital NHS Foundation Trust
      • York, United Kingdom, YO31 8HE
        • York Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Filgotinib
Tablets are administered in accordance with the product label
Other Names:
  • Jyseleca

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment persistence rates
Time Frame: 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.
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
patients' assessment of pain, Visual Analogue Scale (Pain VAS)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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
Time Frame: 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.
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)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfasigma S.p.A.

Investigators

  • Study Director: Alfasigma Study Director, Alfasigma S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2021

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLPG0634-CL-401
  • 48323 (Other Identifier: HMA-EMA Catalogues)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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