Rheumatoid Arthritis
Conditions
Keywords
filgotinib, safety, effectiveness, patient-reported outcome
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.
Interventions
DRUGFilgotinib
Tablets are administered in accordance with the product label
Sponsors
Alfasigma S.p.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Persistence Rate | 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
| Measure | Time frame |
|---|---|
| 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 |
| Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8 | 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 Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score | Up to 24 months |
| Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID) | Up to 24 months |
Countries
France
Contacts
STUDY_DIRECTORAlfasigma Study Director
Alfasigma S.p.A.
Outcome results
None listed