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Completed

NCT Number: NCT05323591

Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France

An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting.

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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

CHU Amiens Picardie site Nord, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants aged ≥18 years with a diagnosis of moderate to severe active RA being prescribed filgotinib in accordance with the local treatment practices and product label for the first time.
  • Female participants of childbearing potential must agree to use contraception while taking filgotinib as per product label.
  • Participants must be willing and able to use an electronic device to complete the study PROs.
  • Participant must sign and date the Informed Consent Form (ICF) before enrollment into the study.

Exclusion criteria

  • Participation in any interventional or non-interventional study without prior approval from the Medical Lead. This does not preclude inclusion of participants enrolled to national registries.
  • Female participant is pregnant or intending to become pregnant while taking filgotinib.

Treatment and study plan

Filgotinib

Drug

Tablets are administered in accordance with the product label

Other names: Jyseleca

Primary outcomes

  1. Treatment Persistence Rate

    Time frame: Month 24

    Treatment persistence rate at 24 months, defined as the percentage of participants continuing to receive filgotinib for 24 months from treatment initiation.

Secondary outcomes

  1. Disease Activity: Percentage of Participants Achieving Disease Activity Score for 28 Joint Count Using C-Reactive Protein (DAS28[CRP]) ≤3.2 and/or Clinical Disease Activity Index (CDAI) ≤10

    Time frame: Up to 24 months

  2. Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8

    Time frame: Up to 24 months

  3. Number of Participants With Adverse Events and Serious Adverse Events

    Time frame: Up to 24 months

  4. Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score

    Time frame: Up to 24 months

  5. Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score

    Time frame: Up to 24 months

  6. Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score

    Time frame: Up to 24 months

  7. Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Alfasigma S.p.A.

Industry

Registry information

Official study title

A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years

Acronym: PARROTFISH

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2022
Registry last updated
May 22, 2026

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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