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

Rheumatoid Arthritis Clinical Trial

— PARROTFISH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05323591
• Other study ID #: GLPG0634-CL-424
• Secondary ID: 49028
• Status: Active, not recruiting
• Start date: May 3, 2022
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Filgotinib
Tablets are administered in accordance with the product label

Locations

Country	Name	City	State
France	CHU Amiens Picardie site Nord	Amiens
France	CHU de Amiens Picardie	Amiens
France	Hopital Avicenne AP-HP	Bobigny
France	CHU Bordeaux	Bordeaux
France	CH de Cahors	Cahors
France	Clinique de l'Infirmerie Protestante de Lyon	Caluire-et-Cuire
France	CH de Cholet	Cholet
France	Hopital Sud Francilien Corbeil Essonne	Corbeil-Essonnes
France	Hopital Roger Salengro	Lille
France	Hopital Saint Joseph	Marseille
France	CHU de Nice	Nice
France	Centre Hospitalier Régional d'Orléans	Orléans
France	Hopital Cochin Service A	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Robert Debre	Reims
France	CHU de Rouen	Rouen
France	Centre Hospitalier Universitaire de Saint Etienne	Saint-Étienne
France	CHU Toulouse	Toulouse
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

France, 

Outcome

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