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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04871919
Other study ID # GLPG0634-CL-401
Secondary ID 48323
Status Active, not recruiting
Phase
First received
Last updated
Start date May 11, 2021
Est. completion date July 2025

Study information

Verified date May 2024
Source Galapagos NV
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1304
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Filgotinib
Tablets are administered in accordance with the product label

Locations

Country Name City State
Belgium Algemeen Stedelijk Ziekenhuis Aalst
Belgium Imelda VZW Bonheiden
Belgium AZ Sint-Jan Brugge-Oostende Brugge
Belgium Hôpital Erasme Brussel
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Grand Hôpital de Charleroi asbl Charleroi
Belgium UZ Antwerpen Edegem
Belgium Reumacentrum Genk Genk
Belgium Reumaclinic Genk Genk
Belgium AZ Maria Middelares Gent
Belgium Reuma Instituut Hasselt
Belgium UZ Leuven Leuven
Belgium CHU de Liège Liège
Belgium ZNA Jan Palfijn Merksem
Belgium CHU UCL Namur asbl - Site Godinne Yvoir
Germany Rheumazentrum Kupka Altenburg
Germany Praxis für Rheumatologie - Amberg Amberg
Germany Rheumatology Center Prof. Neeck Bad Doberan
Germany Charité Campus Mitte, Klinik für Rheumatologie und Klinische Immunologie Berlin
Germany Rheumapraxis am Schlachtensee Berlin
Germany Rheumapraxis Mexikoplatz Berlin
Germany Rheumatologische Schwerpunktpraxis Berlin
Germany Klinik fur Innere Medizin - Rheumatologie - Kreiskrankenhaus Demmin Demmin
Germany Rheumatologisches MVZ Dresden Dresden
Germany Universitatsklinikum Dusseldorf Düsseldorf
Germany Praxis Dilltal Ehringshausen
Germany MVZ Ambulantes Rheumazentrum Erfurt Erfurt
Germany Universitätsmedizin Greifswald, Abteilung Innere Medizin A Greifswald
Germany Internistisch-Rheumatologische Arztpraxis Halle
Germany Praxis für Rheumatologie Hamburg
Germany Rheumatologie im Struenseehaus Hamburg
Germany Rheumazentrum Ruhrgebiet Herne
Germany Praxis für Internistische Rheumatologie Leipzig
Germany Rheumapraxis Leipzig
Germany Rheumatologische Facharztpraxis Magdeburg
Germany Rheumapraxis Mansfeld
Germany Praxis far Rheumatologie, Gastroenterologie und Innere Medizin München
Germany Rheumatologisches Praxiszentrum St. Bonifatius München
Germany Rheumapraxis Neubrandenburg
Germany Medizinischen Versorgungszentrums für Rheumatologie Planegg
Germany Rheumahaus - GbR Potsdam
Germany Rheumazentrum Ratingen Ratingen
Germany Rheumatologisch-immunologische Arztpraxis Templin
Germany Krankenhaus der Barmherzigen Brüder Trier
Germany Klinikverbund St. Antonius und St. Josef GmbH Wuppertal
Italy A.O.U. Policlinico di Bari Bari
Italy ASST degli Spedali Civili di Brescia Brescia
Italy AOU Policlinico Vittorio Emanuele-PO San Marco Catania
Italy A.O.U. di Ferrara - Nuovo ospedale S.Anna Ferrara
Italy S.C. Reumatologia Asl3 Genova
Italy ASST Gaetano Pini CTO Milano
Italy Azienda Osp. Univ. Luigi Vanvitelli Napoli
Italy Policlinico Gemelli Roma
Italy Policlinico Umberto I Univ. Sapienza Roma
Italy Azienda Ospedaliera Universitaria Integrata Di Verona Verona
Netherlands Noordwest Ziekenhuisgroep Alkmaar
Netherlands READE Amsterdam
Netherlands Hagaziekenhuis Den Haag
Netherlands Medisch Spectrum Twente Enschede
Netherlands Reumazorg Zuid West Goes
Netherlands Elkerliek Ziekenhuis Helmond
Netherlands Medisch Centrum Leeuwarden Leeuwarden
Netherlands Erasmus MC Rotterdam
Netherlands Sint Maartenskliniek Ubbergen
Spain Complexo Hospitalario Universitario A Coruña
Spain Hospital del Mar Barcelona
Spain Hospital Universitario Vall d'Hebrón Barcelona
Spain C.H. Regional Reina Sofia Córdoba
Spain Hospital de Mérida Mérida
Spain Hospital Universitario Virgen de La Arrixaca Murcia
Spain Hospital Universitari Son Espases Palma
Spain Hospital Provincial de Pontevedra Pontevedra
Spain Hospital Universitario Hospiten Rambla de Tenerife Santa Cruz De Tenerife
Spain Hospital Clinico Universitario Santiago De Compostela
Spain Hospital Universitario Virgen del Rocio - PPDS Sevilla
Spain Hospital Universitario Virgen Macarena Sevilla
United Kingdom Aberdeen Royal Infirmary PPDS Aberdeen
United Kingdom Royal Free NHS Foundation Trust Barnet
United Kingdom University Hospital Coventry Coventry
United Kingdom Doncaster Royal Infirmary Doncaster
United Kingdom Ninewells Hospital - PPDS Dundee
United Kingdom Western General Hospital Edinburgh - PPDS Edinburgh
United Kingdom Royal Liverpool University Hospital Liverpool
United Kingdom Guy's and St Thomas NHS Foundation Trust - Guy's Hospital London
United Kingdom Kings College Hospital London
United Kingdom Luton and Dunstable Hospital Luton
United Kingdom Freeman Hospital Newcastle
United Kingdom Royal Berkshire Hospital NHS Foundation Trust Reading
United Kingdom York Teaching Hospitals NHS Foundation Trust York

Sponsors (1)

Lead Sponsor Collaborator
Galapagos NV

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 patients' assessment of pain, Visual Analogue Scale (Pain VAS) Up to 24 months
Secondary patients' assessment of fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F score) Up to 24 months
Secondary patients' assessment of Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Up to 24 months
Secondary medication adherence, compliance questionnaire rheumatology 19 (CQR19) Up to 24 months
Secondary medication adherence, compliance questionnaire rheumatology 5 (CQR5) Up to 24 months
Secondary Number of adverse events and serious adverse events Up to 24 months
Secondary patients' assessment of Rheumatoid Arthritis Impact of Disease (RAID) Up to 24 months
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