Status:
ACTIVE_NOT_RECRUITING
Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France
Lead Sponsor:
Alfasigma S.p.A.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief 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 filgotin...
Eligibility Criteria
Inclusion
- Participants aged ≥18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local treatment practices and product label for the first time.
- Female participants of childbearing potential must agree to use contraception while taking filgotinib as per product label.
- Participants must be willing and able to use an electronic device to complete the study PROs.
- Participant must sign and date the Informed Consent Form (ICF) before enrollment into the study.
Exclusion
- Participation in any interventional or non-interventional study without prior approval from the Medical Lead. This does not preclude inclusion of participants enrolled to national registries.
- Female participant is pregnant or intending to become pregnant while taking filgotinib.
Key Trial Info
Start Date :
May 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT05323591
Start Date
May 3 2022
End Date
July 1 2026
Last Update
December 10 2025
Active Locations (17)
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1
CHU Amiens Picardie site Nord
Amiens, France, 80054
2
CHU de Amiens Picardie
Amiens, France, 80054
3
Hopital Avicenne AP-HP
Bobigny, France, 93000
4
CHU Bordeaux
Bordeaux, France, 33000