Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

NCT ID: NCT04871919

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1304 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-11

Study Completion Date

2028-06-30

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Filgotinib

Intervention Type DRUG

Tablets are administered in accordance with the product label

Interventions

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Filgotinib

Tablets are administered in accordance with the product label

Intervention Type DRUG

Other Intervention Names

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Jyseleca

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alfasigma S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfasigma Study Director

Role: STUDY_DIRECTOR

Alfasigma S.p.A.

Locations

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Sint Maartenskliniek

Ubbergen, , Netherlands

Site Status

Complexo Hospitalario Universitario

A Coruña, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Universitario Vall d'Hebrón

Barcelona, , Spain

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C.H. Regional Reina Sofia

Córdoba, , Spain

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Hospital de Mérida

Mérida, , Spain

Site Status

Hospital Universitario Virgen de La Arrixaca

Murcia, , Spain

Site Status

Hospital Universitari Son Espases

Palma, , Spain

Site Status

Hospital Provincial de Pontevedra

Pontevedra, , Spain

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Hospital Universitario Hospiten Rambla de Tenerife

Santa Cruz de Tenerife, , Spain

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Algemeen Stedelijk Ziekenhuis

Aalst, , Belgium

Site Status

Imelda VZW

Bonheiden, , Belgium

Site Status

AZ Sint-Jan Brugge-Oostende

Bruges, , Belgium

Site Status

Hôpital Erasme

Brussels, , Belgium

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

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Grand Hôpital de Charleroi asbl

Charleroi, , Belgium

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UZ Antwerpen

Edegem, , Belgium

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Reumacentrum Genk

Genk, , Belgium

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Reumaclinic Genk

Genk, , Belgium

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AZ Maria Middelares

Ghent, , Belgium

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Reuma Instituut

Hasselt, , Belgium

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UZ Leuven

Leuven, , Belgium

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CHU de Liège

Liège, , Belgium

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ZNA Jan Palfijn

Merksem, , Belgium

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CHU UCL Namur asbl - Site Godinne

Yvoir, , Belgium

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Rheumazentrum Kupka

Altenburg, , Germany

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Praxis für Rheumatologie - Amberg

Amberg, , Germany

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Rheumatology Center Prof. Neeck

Bad Doberan, , Germany

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Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie

Berlin, , Germany

Site Status

Rheumatologische Schwerpunktpraxis

Berlin, , Germany

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Rheumapraxis am Schlachtensee

Berlin, , Germany

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Rheumapraxis Mexikoplatz

Berlin, , Germany

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Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin

Demmin, , Germany

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Rheumatologisches MVZ Dresden

Dresden, , Germany

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Universitatsklinikum Dusseldorf

Düsseldorf, , Germany

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Praxis Dilltal

Ehringshausen, , Germany

Site Status

MVZ Ambulantes Rheumazentrum Erfurt

Erfurt, , Germany

Site Status

Universitätsmedizin Greifswald, Abteilung Innere Medizin A

Greifswald, , Germany

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Internistisch-Rheumatologische Arztpraxis

Halle, , Germany

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Rheumatologie im Struenseehaus

Hamburg, , Germany

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Praxis für Rheumatologie

Hamburg, , Germany

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Rheumazentrum Ruhrgebiet

Herne, , Germany

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Rheumapraxis

Leipzig, , Germany

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Praxis für Internistische Rheumatologie

Leipzig, , Germany

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Rheumatologische Facharztpraxis

Magdeburg, , Germany

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Rheumapraxis

Mansfeld, , Germany

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Praxis far Rheumatologie, Gastroenterologie und Innere Medizin

München, , Germany

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Rheumatologisches Praxiszentrum St. Bonifatius

München, , Germany

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Rheumapraxis

Neubrandenburg, , Germany

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Medizinischen Versorgungszentrums für Rheumatologie

Planegg, , Germany

Site Status

Rheumahaus - GbR

Potsdam, , Germany

Site Status

Rheumazentrum Ratingen

Ratingen, , Germany

Site Status

Rheumatologisch-immunologische Arztpraxis

Templin, , Germany

Site Status

Krankenhaus der Barmherzigen Brüder

Trier, , Germany

Site Status

Klinikverbund St. Antonius und St. Josef GmbH

Wuppertal, , Germany

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A.O.U. Policlinico di Bari

Bari, , Italy

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ASST degli Spedali Civili di Brescia

Brescia, , Italy

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AOU Policlinico Vittorio Emanuele-PO San Marco

Catania, , Italy

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A.O.U. di Ferrara - Nuovo ospedale S.Anna

Ferrara, , Italy

Site Status

S.C. Reumatologia Asl3

Genova, , Italy

Site Status

ASST Gaetano Pini CTO

Milan, , Italy

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Azienda Osp. Univ. Luigi Vanvitelli

Napoli, , Italy

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Policlinico Umberto I Univ. Sapienza

Roma, , Italy

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Policlinico Gemelli

Roma, , Italy

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Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, , Italy

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Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

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READE

Amsterdam, , Netherlands

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Medisch Spectrum Twente

Enschede, , Netherlands

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Reumazorg Zuid West

Goes, , Netherlands

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Elkerliek Ziekenhuis

Helmond, , Netherlands

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Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

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Erasmus MC

Rotterdam, , Netherlands

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Hagaziekenhuis

The Hague, , Netherlands

Site Status

Hospital Clinico Universitario

Santiago de Compostela, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Universitario Virgen del Rocio - PPDS

Seville, , Spain

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Aberdeen Royal Infirmary PPDS

Aberdeen, , United Kingdom

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Royal Free NHS Foundation Trust

Barnet, , United Kingdom

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University Hospital Coventry

Coventry, , United Kingdom

Site Status

Doncaster Royal Infirmary

Doncaster, , United Kingdom

Site Status

Ninewells Hospital - PPDS

Dundee, , United Kingdom

Site Status

Western General Hospital Edinburgh - PPDS

Edinburgh, , United Kingdom

Site Status

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status

Guy's and St Thomas NHS Foundation Trust - Guy's Hospital

London, , United Kingdom

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Kings College Hospital

London, , United Kingdom

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Luton and Dunstable Hospital

Luton, , United Kingdom

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Freeman Hospital

Newcastle, , United Kingdom

Site Status

Royal Berkshire Hospital NHS Foundation Trust

Reading, , United Kingdom

Site Status

York Teaching Hospitals NHS Foundation Trust

York, , United Kingdom

Site Status

Countries

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Belgium Germany Italy Netherlands Spain United Kingdom

Other Identifiers

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48323

Identifier Type: OTHER

Identifier Source: secondary_id

GLPG0634-CL-401

Identifier Type: -

Identifier Source: org_study_id

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