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

NCT ID: NCT05323591

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-03

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Filgotinib

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

Filgotinib

Intervention Type DRUG

Tablets are administered in accordance with the product label

Interventions

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Filgotinib

Tablets are administered in accordance with the product label

Intervention Type DRUG

Other Intervention Names

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Jyseleca

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alfasigma S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfasigma Study Director

Role: STUDY_DIRECTOR

Alfasigma S.p.A.

Locations

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CHU Amiens Picardie site Nord

Amiens, , France

Site Status

CHU de Amiens Picardie

Amiens, , France

Site Status

Hopital Avicenne AP-HP

Bobigny, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

CH de Cahors

Cahors, , France

Site Status

Clinique de l'Infirmerie Protestante de Lyon

Caluire-et-Cuire, , France

Site Status

Hopital Sud Francilien Corbeil Essonne

Corbeil-Essonnes, , France

Site Status

Hopital Roger Salengro

Lille, , France

Site Status

CHU de Nice

Nice, , France

Site Status

Centre Hospitalier Régional d'Orléans

Orléans, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hopital Cochin Service A

Paris, , France

Site Status

Hopital Robert Debre

Reims, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, , France

Site Status

CHU Toulouse

Toulouse, , France

Site Status

CHRU de Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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49028

Identifier Type: OTHER

Identifier Source: secondary_id

GLPG0634-CL-424

Identifier Type: -

Identifier Source: org_study_id

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