NCT05323591CompletedNot Applicable
A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alfasigma S.p.A.
- Enrollment
- 155
- Locations
- 34
- Primary Endpoint
- Treatment Persistence Rate
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
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)
Investigators
Study Sites (34)
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