Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

Study Overview
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Brief Summary
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An observational study to describe the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active rheumatoid arthritis (RA) receiving filgotinib in real-world setting.

Official Title
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A Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving Filgotinib

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Filgotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥ 18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local standard of care and product label for the first time. Patients must be willing and able to use an electronic device to complete the study patient-reported outcome (PRO). Exclusion Criteria: - Participation in any other interventional or non-interventional study without prior approval from the Medical Monitor. This does not preclude inclusion of patients enrolled to national registries.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Filgotinib<br>Individuals will receive treatment for moderate to severe active rheumatoid arthritis 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment persistence rates | To evaluate the treatment persistence rate at 24 months, defined as the rate of patients continuing to receive filgotinib 24 months from treatment initiation. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients' assessment of pain, Visual Analogue Scale (Pain VAS) |  | Up to 24 months | 
| patients' assessment of fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F score) |  | Up to 24 months | 
| patients' assessment of Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) |  | Up to 24 months | 
| medication adherence, compliance questionnaire rheumatology 19 (CQR19) |  | Up to 24 months | 
| medication adherence, compliance questionnaire rheumatology 5 (CQR5) |  | Up to 24 months | 
| Number of adverse events and serious adverse events |  | Up to 24 months | 
| patients' assessment of Rheumatoid Arthritis Impact of Disease (RAID) |  | Up to 24 months | 

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