Clinical trial NCT05323591: Prospective Observational Study of Filgotinib in Participants With Rheumatoid Arthritis in France
Official title: A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: filgotinib
safety
effectiveness
patient-reported outcome
Lead sponsor: Alfasigma S.p.A.
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Persistence Rate
timeFrame: Month 24
Secondary outcomes:
measure: 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
timeFrame: Up to 24 months
measure: Disease Activity: Percentage of Participants Achieving DAS28(CRP) ≤2.6 and/or CDAI ≤2.8
timeFrame: Up to 24 months
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to 24 months
measure: Participants' Assessment of Pain: Pain Visual Analogue Scale (VAS) Score
timeFrame: Up to 24 months
measure: Participants' Assessment of Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
timeFrame: Up to 24 months
measure: Participants' Assessment of Work Activities Impairment: Work Productivity and Activity Impairment: Rheumatoid Arthritis (WPAI-RA) Score
timeFrame: Up to 24 months
measure: Participants' Assessment of Rheumatoid Arthritis Impact of Disease (RAID)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie site Nord
city: Amiens
country: France
facility: CHU de Amiens Picardie
city: Bobigny
country: France
facility: Hopital Avicenne AP-HP
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Cahors
country: France
facility: CH de Cahors
city: Caluire-et-Cuire
country: France
facility: Clinique de l'Infirmerie Protestante de Lyon
city: Corbeil-Essonnes
country: France
facility: Hopital Sud Francilien Corbeil Essonne
city: Lille
country: France
facility: Hopital Roger Salengro
city: Nice
country: France
facility: CHU de Nice
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Cochin Service A
city: Reims
country: France
facility: Hopital Robert Debre
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: Alfasigma S.p.A.
name: Alfasigma Study Director
role: STUDY_DIRECTOR
References: