Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

Active, not recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Filgotinib

• Registration Number: NCT04871919
• Lead Sponsor: Alfasigma S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2021-05-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-17
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1304

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Filgotinib	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

Primary Outcome Measures

Name	Time	Method
Treatment persistence rates	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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (87)

Algemeen Stedelijk Ziekenhuis; 🇧🇪 Aalst, Belgium

Imelda VZW; 🇧🇪 Bonheiden, Belgium

AZ Sint-Jan Brugge-Oostende; 🇧🇪 Brugge, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Hôpital Erasme; 🇧🇪 Brussel, Belgium

Grand Hôpital de Charleroi asbl; 🇧🇪 Charleroi, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

Reumacentrum Genk; 🇧🇪 Genk, Belgium

Reumaclinic Genk; 🇧🇪 Genk, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Belgium

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