A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years

Alfasigma S.p.A.17 sites in 1 country155 target enrollmentMay 3, 2022

ConditionsRheumatoid Arthritis

InterventionsFilgotinib

Overview

Phase: N/A
Intervention: Filgotinib
Conditions: Rheumatoid Arthritis
Sponsor: Alfasigma S.p.A.
Enrollment: 155
Locations: 17
Primary Endpoint: Treatment Persistence Rate
Status: Active, Not Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 filgotinib in real-world setting.

Registry

clinicaltrials.gov

Start Date

May 3, 2022

End Date

July 1, 2026

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Alfasigma S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Arms & Interventions

Filgotinib

Participants will receive treatment for moderate to severe active RA with at least one dose of filgotinib in accordance with the product label.

Intervention: Filgotinib

Outcomes

Primary Outcomes

Treatment Persistence Rate

Time Frame: Month 24

Treatment persistence rate at 24 months, defined as the percentage of participants continuing to receive filgotinib for 24 months from treatment initiation.

Secondary Outcomes

Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8(Up to 24 months)
Disease Activity: Percentage of Participants Achieving Disease Activity Score for 28 Joint Count Using C-Reactive Protein (DAS28[CRP]) ≤3.2 and/or Clinical Disease Activity Index (CDAI) ≤10(Up to 24 months)
Number of Participants With Adverse Events and Serious Adverse Events(Up to 24 months)
Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score(Up to 24 months)
Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score(Up to 24 months)
Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)(Up to 24 months)
Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score(Up to 24 months)