Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Keywords

filgotinib, safety, effectiveness, patient reported outcome

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.

Gerd R Burmester, James Galloway, K. Bevers, Jérôme Avouac, Susana Romero-Yuste et al. (11 authors)

Rheumatology and Therapy2026-07-31

10.1007/s40744-026-00874-x

P110 Baseline characteristics, disease activity, patient-reported outcomes and safety in patients with rheumatoid arthritis treated with filgotinib in the UK: up to 1-year interim results from FILOSOPHY

Muhammad K Nisar, Smita Bhat, Ouafia Bouzid, Tariq Daud, Thomas P. A. Debray et al. (9 authors)

Lara D. Veeken2025-04-01

10.1093/rheumatology/keaf142.150

Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study

René Westhovens, Kevin Winthrop, Arthur Kavanaugh, Maria Greenwald, Lorenzo Dagna et al. (14 authors)

RMD Open2025-01-014 citations

10.1136/rmdopen-2024-004857

P118 Patient-reported outcomes, disease activity and safety in UK patients with rheumatoid arthritis treated with filgotinib: up to six-month interim results from a prospective observational study (FILOSOPHY)

Bruce Kirkham, Neil D McKay, Arthur G. Pratt, Jane Barry, Ouafia Bouzid et al. (9 authors)

Lara D. Veeken2024-04-01

10.1093/rheumatology/keae163.159

P118 Baseline Characteristics of and Early Outcomes in the First 200 Patients With Rheumatoid arthritis Treated With Filgotinib in a Prospective Observational Study

James Galloway, K. Bevers, Patrick Verschueren, Roberto Caporali, Susana Romero Yuste et al. (10 authors)

Lara D. Veeken2023-04-011 citations

10.1093/rheumatology/kead104.159

Interventions

DRUGFilgotinib

Tablets are administered in accordance with the product label

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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.
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.
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.
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.

Countries

Belgium, Germany, Italy, Netherlands, Spain, United Kingdom

Outcome results

None listed