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NCT Number: NCT04871919

Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Algemeen Stedelijk Ziekenhuis, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filgotinib

Drug

Tablets are administered in accordance with the product label

Other names: Jyseleca

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. patients' assessment of Rheumatoid Arthritis Impact of Disease (RAID)

    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.

Sponsors and collaborators

Lead sponsor

Alfasigma S.p.A.

Industry

Registry information

Official study title

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

Acronym: FILOSOPHY

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 4, 2021
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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