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

Alfasigma S.p.A.87 sites in 3 countries1,304 target enrollmentMay 11, 2021

ConditionsRheumatoid Arthritis

InterventionsFilgotinib

DrugsFilgotinib

Overview

Phase: N/A
Intervention: Filgotinib
Conditions: Rheumatoid Arthritis
Sponsor: Alfasigma S.p.A.
Enrollment: 1304
Locations: 87
Primary Endpoint: Treatment persistence rates
Status: Active, Not Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 11, 2021

End Date

June 1, 2028

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Alfasigma S.p.A.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Filgotinib

Individuals will receive treatment for moderate to severe active rheumatoid arthritis with at least one dose of filgotinib in accordance with the product label

Intervention: Filgotinib

Outcomes

Primary Outcomes

Treatment persistence rates

Time Frame: Up to 24 months

To evaluate the treatment persistence rate at 24 months, defined as the rate of patients continuing to receive filgotinib 24 months from treatment initiation.

Secondary Outcomes

patients' assessment of pain, Visual Analogue Scale (Pain VAS)(Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.)
patients' assessment of fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F score)(Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.)
patients' assessment of Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA)(Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.)
medication adherence, compliance questionnaire rheumatology 19 (CQR19)(Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.)
medication adherence, compliance questionnaire rheumatology 5 (CQR5)(Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.)
Number of adverse events and serious adverse events(Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.)
patients' assessment of Rheumatoid Arthritis Impact of Disease (RAID)(Up to 24 months; it will be evaluated as exploratory objectives in the optional 24-months extension period; i.e. at approximately 30, 36, 42, and 48 months.)