Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France (PARROTFISH)

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Filgotinib

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens Picardie site Nord
  • Amiens, France, 80054
    • CHU de Amiens Picardie
  • Bobigny, France, 93000
    • Hopital Avicenne AP-HP
  • Bordeaux, France, 33000
    • CHU Bordeaux
  • Cahors, France, 46005
    • CH de Cahors
  • Caluire-et-Cuire, France, 69300
    • Clinique de l'Infirmerie Protestante de Lyon
  • Corbeil-Essonnes, France, 91106
    • Hopital Sud Francilien Corbeil Essonne
  • Lille, France, 59037
    • Hôpital Roger Salengro
  • Nice, France, 06000
    • CHU de Nice
  • Orléans, France, 45100
    • Centre Hospitalier Régional D'orléans
  • Paris, France, 75012
    • Hôpital Saint Antoine
  • Paris, France, 75014
    • Hopital Cochin Service A
  • Reims, France, 51092
    • Hôpital Robert Debré
  • Rouen, France, 76000
    • CHU de Rouen
  • Saint-Etienne, France, 42000
    • Centre Hospitalier Universitaire de Saint Etienne
  • Toulouse, France, 31000
    • CHU Toulouse
  • Tours, France, 37044
    • Chru De Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of participants aged ≥ 18 years with moderate to severe active RA receiving filgotinib who will be enrolled in France.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Filgotinib; Participants will receive treatment for moderate to severe active RA with at least one dose of filgotinib in accordance with the product label.	Drug: Filgotinib; Tablets are administered in accordance with the product label; Other Names: Jyseleca

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Persistence Rate	Treatment persistence rate at 24 months, defined as the percentage of participants continuing to receive filgotinib for 24 months from treatment initiation.	Month 24

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Up to 24 months
Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8	Up to 24 months
Number of Participants With Adverse Events and Serious Adverse Events	Up to 24 months
Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score	Up to 24 months
Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score	Up to 24 months
Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)	Up to 24 months
Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score	Up to 24 months

Collaborators and Investigators

• Sponsor: Alfasigma S.p.A.
• Investigators: Study Director: Alfasigma Study Director, Alfasigma S.p.A.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: safety; effectiveness; filgotinib; patient-reported outcome
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; GLPG0634
• Other Study ID Numbers: GLPG0634-CL-424; 49028 (Other Identifier: HMA-EMA Catalogues)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No