Rheumatoid ArthritisFILOSOPHYNCT04871919
Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Alfasigma S.p.A. at 89 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- How many people
- 1,304 participants
- Where
- 89 sitesin 6 countries
- Study dates
- 11 May 2021to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
89 sites in 6 countries.
89 sites in 6 countries
Germany30 sites
Rheumazentrum Kupka
Altenburg, 4600
Praxis für Rheumatologie - Amberg
Amberg, 92224
Rheumatology Center Prof. Neeck
Bad Doberan, 18209
Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie
Berlin, 10117
Rheumatologische Schwerpunktpraxis
Berlin, 12161
Rheumapraxis am Schlachtensee
Berlin, 14129
Rheumapraxis Mexikoplatz
Berlin, 14163
Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin
Demmin, 17109
Rheumatologisches MVZ Dresden
Dresden, 01109
Universitatsklinikum Dusseldorf
Düsseldorf, 40225
Praxis Dilltal
Ehringshausen, 35630
MVZ Ambulantes Rheumazentrum Erfurt
Erfurt, 99096
Universitätsmedizin Greifswald, Abteilung Innere Medizin A
Greifswald, 17475
Internistisch-Rheumatologische Arztpraxis
Halle, 06128
Rheumatologie im Struenseehaus
Hamburg, 22767
Praxis für Rheumatologie
Hamburg, 2291
Rheumazentrum Ruhrgebiet
Herne, 44649
Rheumapraxis
Leipzig, 04109
Praxis für Internistische Rheumatologie
Leipzig, 04129
Rheumatologische Facharztpraxis
Magdeburg, 39104
Rheumapraxis
Mansfeld, 6343
Praxis far Rheumatologie, Gastroenterologie und Innere Medizin
München, 80639
Rheumatologisches Praxiszentrum St. Bonifatius
München, 81541
Rheumapraxis
Neubrandenburg, 17033
Medizinischen Versorgungszentrums für Rheumatologie
Planegg, 82152
Rheumahaus - GbR
Potsdam, 14469
Rheumazentrum Ratingen
Ratingen, 40878
Rheumatologisch-immunologische Arztpraxis
Templin, 17268
Krankenhaus der Barmherzigen Brüder
Trier, 54292
Klinikverbund St. Antonius und St. Josef GmbH
Wuppertal, 42283
Belgium15 sites
Algemeen Stedelijk Ziekenhuis
Aalst, 9300
Imelda VZW
Bonheiden, 2820
AZ Sint-Jan Brugge-Oostende
Bruges, 8000
Hôpital Erasme
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
Grand Hôpital de Charleroi asbl
Charleroi, 6000
UZ Antwerpen
Edegem, 2650
Reumacentrum Genk
Genk, 3600
Reumaclinic Genk
Genk, 3600
AZ Maria Middelares
Ghent, 9000
Reuma Instituut
Hasselt, 3500
UZ Leuven
Leuven, 3000
CHU de Liège
Liège, 4000
ZNA Jan Palfijn
Merksem, 2170
CHU UCL Namur asbl - Site Godinne
Yvoir, 5530
United Kingdom13 sites
Aberdeen Royal Infirmary PPDS
Aberdeen, AB25 2ZA
Royal Free NHS Foundation Trust
Barnet, EN5 3DJ
University Hospital Coventry
Coventry, CV2 2DX
Doncaster Royal Infirmary
Doncaster, DN2 5LT
Ninewells Hospital - PPDS
Dundee, DD1 95Y
Western General Hospital Edinburgh - PPDS
Edinburgh, EH4 2XU
Royal Liverpool University Hospital
Liverpool, L7 8XP
Guy's and St Thomas NHS Foundation Trust - Guy's Hospital
London, SE5 9RS
Kings College Hospital
London, SE5 9RS
Luton and Dunstable Hospital
Luton, LU4 0DZ
Freeman Hospital
Newcastle, NE1 4LP
Royal Berkshire Hospital NHS Foundation Trust
Reading, RG1 5AN
York Teaching Hospitals NHS Foundation Trust
York, YO31 8HE
Spain12 sites
Complexo Hospitalario Universitario
A Coruña, 15006
Hospital del Mar
Barcelona, 8003
Hospital Universitario Vall d'Hebrón
Barcelona, 8025
C.H. Regional Reina Sofia
Córdoba, 14004
Hospital de Mérida
Mérida, 06800
Hospital Universitario Virgen de La Arrixaca
Murcia, 30120
Hospital Universitari Son Espases
Palma, 07120
Hospital Provincial de Pontevedra
Pontevedra, 36001
Hospital Universitario Hospiten Rambla de Tenerife
Santa Cruz de Tenerife, 38003
Hospital Clinico Universitario
Santiago de Compostela, 15706
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Italy10 sites
A.O.U. Policlinico di Bari
Bari, 70124
ASST degli Spedali Civili di Brescia
Brescia, 25123
AOU Policlinico Vittorio Emanuele-PO San Marco
Catania, 95121
A.O.U. di Ferrara - Nuovo ospedale S.Anna
Ferrara, 44124
S.C. Reumatologia Asl3
Genova, 16125
ASST Gaetano Pini CTO
Milan, 20122
Azienda Osp. Univ. Luigi Vanvitelli
Naples, 80100
Policlinico Umberto I Univ. Sapienza
Roma, 00161
Policlinico Gemelli
Roma, 00168
Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, 37126
Netherlands9 sites
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD
READE
Amsterdam, 1054 HW
Medisch Spectrum Twente
Enschede, 7512 KZ
Reumazorg Zuid West
Goes, 4462 EV
Elkerliek Ziekenhuis
Helmond, 5707 HA
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
Erasmus MC
Rotterdam, 3015 GD
Hagaziekenhuis
The Hague, 2545 AA
Sint Maartenskliniek
Ubbergen, 6574 NA
About this study
Official 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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Filgotinib
- Keywords
- filgotinib, safety, effectiveness, patient reported outcome
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Also called Jyseleca
Tablets are administered in accordance with the product label
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (7)
patients' assessment of pain, Visual Analogue Scale (Pain VAS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start11 May 2021
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alfasigma Study Director, Study director, Alfasigma S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871919
- Sponsor's protocol ID
- GLPG0634-CL-401
- Other IDs
- 48323
- Acronym
- FILOSOPHY
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burmester GR, Galloway J, Bevers K, Avouac J, Romero-Yuste S, Caporali RF, Betteridge N, Van der Donckt C, Debray TPA, Tandjaoui Bouzid O, Verschueren P. Filgotinib in Moderate to Severe Rheumatoid Arthritis in a Real-World Setting: Up to 6-Month Effectiveness, Patient-Reported Outcomes, and Persistence, and up to 24-Month Safety from More than 1400 Patients in the FILOSOPHY and PARROTFISH Studies. Rheumatol Ther. 2026 Jul 31. doi: 10.1007/s40744-026-00874-x. Online ahead of print.
PubMed 42536126
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04871919
- Acronym / sponsor ID
- FILOSOPHY / GLPG0634-CL-401
- Conditions
- Rheumatoid Arthritis
- Keywords
- filgotinib, safety, effectiveness, patient reported outcome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,304 participants (actual)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Study start
- 11 May 2021 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgotinib | – | Drug: FilgotinibIndividuals will receive treatment for moderate to severe active rheumatoid arthritis with at least one dose of filgotinib in accordance with the product label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibAlso: JyselecaTablets are administered in accordance with the product label | Drug | Filgotinib |
Primary outcome
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.
7 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 42536126Burmester GR, Galloway J, Bevers K, Avouac J, Romero-Yuste S, Caporali RF, Betteridge N, Van der Donckt C, Debray TPA, Tandjaoui Bouzid O, Verschueren P. Filgotinib in Moderate to Severe Rheumatoid Arthritis in a Real-World Setting: Up to 6-Month Effectiveness, Patient-Reported Outcomes, and Persistence, and up to 24-Month Safety from More than 1400 Patients in the FILOSOPHY and PARROTFISH Studies. Rheumatol Ther. 2026 Jul 31. doi: 10.1007/s40744-026-00874-x. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfasigma Study Director study director
Alfasigma S.p.A.
89 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Alfasigma S.p.A. at 89 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in Germany, Belgium, United Kingdom, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment persistence rates (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04871919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.