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

N/AActive Not RecruitingNCT05323591

Alfasigma S.p.A.155 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

155

Conditions

Rheumatoid Arthritis

Interventions

FilgotinibDRUG

Tablets are administered in accordance with the product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

CHU Amiens Picardie site Nord

Amiens, France

CHU de Amiens Picardie

Amiens, France

Hopital Avicenne AP-HP

Bobigny, France

Outcomes

Primary Outcomes

Treatment Persistence Rate

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

Time frame: Month 24

Secondary Outcomes

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

Time frame: Up to 24 months

Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8

Time frame: Up to 24 months

Number of Participants With Adverse Events and Serious Adverse Events

Time frame: Up to 24 months

Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score

Time frame: Up to 24 months

Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score

Time frame: Up to 24 months

Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score

Time frame: Up to 24 months

Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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