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

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.

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

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Filgotinib


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Filgotinib<br>Participants will receive treatment for moderate to severe active RA with at least one dose of filgotinib in accordance with the product label. | Drug: Filgotinib<br>* Tablets are administered in accordance with the product label<br>* Other names: Jyseleca;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
filgotinib, safety, effectiveness, patient-reported outcome