Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

N/AActive Not RecruitingNCT04871919

Alfasigma S.p.A.1,304 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,304

Conditions

Rheumatoid Arthritis

Interventions

Tablets are administered in accordance with the product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (89)

Outcomes

Primary Outcomes

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.

Time frame: Up to 24 months

Secondary Outcomes

patients' assessment of pain, Visual Analogue Scale (Pain VAS)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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NCT04871919 - Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis | Crick | Crick