Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France

Last updated: December 13, 2024
Sponsor: Alfasigma S.p.A.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

Filgotinib

Clinical Study ID

NCT05323591
GLPG0634-CL-424
49028
EUPAS46020
  • Ages > 18
  • All Genders

Study Summary

An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants aged ≥18 years with a diagnosis of moderate to severe active RA beingprescribed filgotinib in accordance with the local treatment practices and productlabel for the first time.

  • Female participants of childbearing potential must agree to use contraception whiletaking filgotinib as per product label.

  • Participants must be willing and able to use an electronic device to complete thestudy PROs.

  • Participant must sign and date the Informed Consent Form (ICF) before enrollmentinto the study.

Exclusion

Exclusion Criteria:

  • Participation in any interventional or non-interventional study without priorapproval from the Medical Lead. This does not preclude inclusion of participantsenrolled to national registries.

  • Female participant is pregnant or intending to become pregnant while takingfilgotinib.

Study Design

Total Participants: 155
Treatment Group(s): 1
Primary Treatment: Filgotinib
Phase:
Study Start date:
May 03, 2022
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • CHU Amiens Picardie site Nord

    Amiens, 80054
    France

    Site Not Available

  • CHU de Amiens Picardie

    Amiens, 80054
    France

    Site Not Available

  • Hopital Avicenne AP-HP

    Bobigny, 93000
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33000
    France

    Site Not Available

  • CH de Cahors

    Cahors, 46005
    France

    Site Not Available

  • Clinique de l'Infirmerie Protestante de Lyon

    Caluire-et-Cuire, 69300
    France

    Site Not Available

  • CH de Cholet

    Cholet, 49325
    France

    Site Not Available

  • Hopital Sud Francilien Corbeil Essonne

    Corbeil-Essonnes, 91106
    France

    Site Not Available

  • Hopital Roger Salengro

    Lille, 59037
    France

    Site Not Available

  • Hopital Saint Joseph

    Marseille, 13008
    France

    Site Not Available

  • CHU de Nice

    Nice, 06000
    France

    Site Not Available

  • Centre Hospitalier Régional d'Orléans

    Orléans, 45100
    France

    Site Not Available

  • Hopital Cochin Service A

    Paris, 75014
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris, 75012
    France

    Site Not Available

  • Hopital Robert Debre

    Reims, 51092
    France

    Site Not Available

  • CHU de Rouen

    Rouen, 76000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Étienne, 42000
    France

    Site Not Available

  • CHU Toulouse

    Toulouse, 31000
    France

    Site Not Available

  • CHRU de Tours

    Tours, 37044
    France

    Site Not Available

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