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

Active, not recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Filgotinib

• Registration Number: NCT05323591
• Lead Sponsor: Alfasigma S.p.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-12
• Study Start: 2022-05-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Filgotinib	Filgotinib	Participants will receive treatment for moderate to severe active RA with at least one dose of filgotinib in accordance with the product label.

Primary Outcome Measures

Name	Time	Method
Treatment Persistence Rate	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 Outcome Measures

Name	Time	Method
Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8	Up to 24 months
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
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 Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score	Up to 24 months
Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)	Up to 24 months
Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score	Up to 24 months

Trial Locations

Locations (17)

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

Hopital Sud Francilien Corbeil Essonne; 🇫🇷 Corbeil-Essonnes, France

Hopital Roger Salengro; 🇫🇷 Lille, France

CHU de Nice; 🇫🇷 Nice, France

Centre Hospitalier Régional d'Orléans; 🇫🇷 Orléans, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital Cochin Service A; 🇫🇷 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, France