NCT05323591

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
May 2022Jul 2026

First Submitted

Initial submission to the registry

April 5, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

May 3, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

4.2 years

First QC Date

April 5, 2022

Last Update Submit

December 3, 2025

Conditions

Rheumatoid Arthritis

Keywords

filgotinibsafetyeffectivenesspatient-reported outcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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 Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score

    Up to 24 months

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

FilgotinibDRUG

Tablets are administered in accordance with the product label

Also known as: Jyseleca
Filgotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Female participant is pregnant or intending to become pregnant while taking filgotinib.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CHU Amiens Picardie site Nord

Amiens, 80054, France

Location

CHU de Amiens Picardie

Amiens, 80054, France

Location

Hopital Avicenne AP-HP

Bobigny, 93000, France

Location

CHU Bordeaux

Bordeaux, 33000, France

Location

CH de Cahors

Cahors, 46005, France

Location

Clinique de l'Infirmerie Protestante de Lyon

Caluire-et-Cuire, 69300, France

Location

Hopital Sud Francilien Corbeil Essonne

Corbeil-Essonnes, 91106, France

Location

Hopital Roger Salengro

Lille, 59037, France

Location

CHU de Nice

Nice, 06000, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, 45100, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Hopital Cochin Service A

Paris, 75014, France

Location

Hopital Robert Debre

Reims, 51092, France

Location

CHU de Rouen

Rouen, 76000, France

Location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42000, France

Location

CHU Toulouse

Toulouse, 31000, France

Location

CHRU de Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alfasigma Study Director

    Alfasigma S.p.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 12, 2022

Study Start

May 3, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(17)