Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

NCT04871919 — Active not recruiting, 1304 participants, Alfasigma S.p.A.

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

RegistryNCT04871919, acronym FILOSOPHY
StatusActive not recruiting
Study typeObservational
Enrollment1304 (Actual)
SponsorAlfasigma S.p.A. (Industry)
ConditionsRheumatoid Arthritis
InterventionsFilgotinib (Drug)
Datesstart 2021-05-11, primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2021-05-04, last updated 2025-09-15
Locations89 sites in Belgium, Germany, Italy, Netherlands, Spain, United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Rheumatoid Arthritis All trials of Filgotinib

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
FilgotinibDrug: FilgotinibIndividuals will receive treatment for moderate to severe active rheumatoid arthritis with at least one dose of filgotinib in accordance with the product label
  • Filgotinib (Drug), also known as Jyseleca: Tablets are administered in accordance with the product label

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (89)

FacilityCityCountryStatus
Algemeen Stedelijk ZiekenhuisAalstBelgium
Imelda VZWBonheidenBelgium
AZ Sint-Jan Brugge-OostendeBrugesBelgium
Hôpital ErasmeBrusselsBelgium
Cliniques Universitaires Saint-LucBrusselsBelgium
Grand Hôpital de Charleroi asblCharleroiBelgium
UZ AntwerpenEdegemBelgium
Reumacentrum GenkGenkBelgium
Reumaclinic GenkGenkBelgium
AZ Maria MiddelaresGhentBelgium
Reuma InstituutHasseltBelgium
UZ LeuvenLeuvenBelgium
CHU de LiègeLiègeBelgium
ZNA Jan PalfijnMerksemBelgium
CHU UCL Namur asbl - Site GodinneYvoirBelgium
Rheumazentrum KupkaAltenburgGermany
Praxis für Rheumatologie - AmbergAmbergGermany
Rheumatology Center Prof. NeeckBad DoberanGermany
Charité Campus Mitte, Klinik für Rheumatologie und Klinische ImmunologieBerlinGermany
Rheumatologische SchwerpunktpraxisBerlinGermany
Rheumapraxis am SchlachtenseeBerlinGermany
Rheumapraxis MexikoplatzBerlinGermany
Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus DemminDemminGermany
Rheumatologisches MVZ DresdenDresdenGermany
Universitatsklinikum DusseldorfDüsseldorfGermany
Praxis DilltalEhringshausenGermany
MVZ Ambulantes Rheumazentrum ErfurtErfurtGermany
Universitätsmedizin Greifswald, Abteilung Innere Medizin AGreifswaldGermany
Internistisch-Rheumatologische ArztpraxisHalleGermany
Rheumatologie im StruenseehausHamburgGermany
Praxis für RheumatologieHamburgGermany
Rheumazentrum RuhrgebietHerneGermany
RheumapraxisLeipzigGermany
Praxis für Internistische RheumatologieLeipzigGermany
Rheumatologische FacharztpraxisMagdeburgGermany
RheumapraxisMansfeldGermany
Praxis far Rheumatologie, Gastroenterologie und Innere MedizinMünchenGermany
Rheumatologisches Praxiszentrum St. BonifatiusMünchenGermany
RheumapraxisNeubrandenburgGermany
Medizinischen Versorgungszentrums für RheumatologiePlaneggGermany
Rheumahaus - GbRPotsdamGermany
Rheumazentrum RatingenRatingenGermany
Rheumatologisch-immunologische ArztpraxisTemplinGermany
Krankenhaus der Barmherzigen BrüderTrierGermany
Klinikverbund St. Antonius und St. Josef GmbHWuppertalGermany
A.O.U. Policlinico di BariBariItaly
ASST degli Spedali Civili di BresciaBresciaItaly
AOU Policlinico Vittorio Emanuele-PO San MarcoCataniaItaly
A.O.U. di Ferrara - Nuovo ospedale S.AnnaFerraraItaly
S.C. Reumatologia Asl3GenovaItaly
ASST Gaetano Pini CTOMilanItaly
Azienda Osp. Univ. Luigi VanvitelliNaplesItaly
Policlinico Umberto I Univ. SapienzaRomaItaly
Policlinico GemelliRomaItaly
Azienda Ospedaliera Universitaria Integrata Di VeronaVeronaItaly
Noordwest ZiekenhuisgroepAlkmaarNetherlands
READEAmsterdamNetherlands
Medisch Spectrum TwenteEnschedeNetherlands
Reumazorg Zuid WestGoesNetherlands
Elkerliek ZiekenhuisHelmondNetherlands
Medisch Centrum LeeuwardenLeeuwardenNetherlands
Erasmus MCRotterdamNetherlands
HagaziekenhuisThe HagueNetherlands
Sint MaartenskliniekUbbergenNetherlands
Complexo Hospitalario UniversitarioA CoruñaSpain
Hospital del MarBarcelonaSpain
Hospital Universitario Vall d'HebrónBarcelonaSpain
C.H. Regional Reina SofiaCórdobaSpain
Hospital de MéridaMéridaSpain
Hospital Universitario Virgen de La ArrixacaMurciaSpain
Hospital Universitari Son EspasesPalmaSpain
Hospital Provincial de PontevedraPontevedraSpain
Hospital Universitario Hospiten Rambla de TenerifeSanta Cruz de TenerifeSpain
Hospital Clinico UniversitarioSantiago de CompostelaSpain
Hospital Universitario Virgen MacarenaSevilleSpain
Hospital Universitario Virgen del Rocio - PPDSSevilleSpain
Aberdeen Royal Infirmary PPDSAberdeenUnited Kingdom
Royal Free NHS Foundation TrustBarnetUnited Kingdom
University Hospital CoventryCoventryUnited Kingdom
Doncaster Royal InfirmaryDoncasterUnited Kingdom
Ninewells Hospital - PPDSDundeeUnited Kingdom
Western General Hospital Edinburgh - PPDSEdinburghUnited Kingdom
Royal Liverpool University HospitalLiverpoolUnited Kingdom
Guy's and St Thomas NHS Foundation Trust - Guy's HospitalLondonUnited Kingdom
Kings College HospitalLondonUnited Kingdom
Luton and Dunstable HospitalLutonUnited Kingdom
Freeman HospitalNewcastleUnited Kingdom
Royal Berkshire Hospital NHS Foundation TrustReadingUnited Kingdom
York Teaching Hospitals NHS Foundation TrustYorkUnited Kingdom

+Publications

  • Results publication: 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. PMID 42536126

+Investigators

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