Clinical trial NCT05082805: Therapeutic Strategy Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis
Official title: Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 400
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: RA or PsA patient undergoing treatment with MTX for at least 3 months and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease will be asked to participate from bDMARD or tsDMARD treatment introduction (inclusion visit) up to 24 months after inclusion.

Brief summary: This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.

The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.


Eligibility criteria: Inclusion Criteria:

* Major patient (age ≥ 18 years)
* Patient with RA according to American College of Rheumatology (ACR) / European Congress of Rheumatology (EULAR) 2010 or ACR 1987 or patient with PsA according to ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria
* Patient undergoing treatment with methotrexate (MTX) (oral or injectable) initiated for at least 3 months.
* Naïve patient of biotherapy or tsDMARD and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease.
* Patient informed and accepting the computer processing of his/her medical data and informed of his/her rights of access and rectification.

Exclusion Criteria:

* Patient participating in an interventional study in rheumatology
* Patient with axial spondyloarthritis (for patients with PsA)

Primary outcomes:
measure: The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.
timeFrame: 12 months after inclusion
Secondary outcomes:
measure: Main criteria analysis
timeFrame: 24 months after inclusion
measure: Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
timeFrame: 12 and 24 months after inclusion
measure: Disease outcome
timeFrame: 12 and 24 months after inclusion
measure: Patient adherence to treatment
timeFrame: 12 and 24 months after inclusion
measure: Fatigue and pain
timeFrame: 12 and 24 months after inclusion
measure: Functional capacity (Health Assessment Questionnaire (HAQ))
timeFrame: 12 and 24 months after inclusion
measure: Cross-perception (doctor / patient) about participation in the "shared medical decision"
timeFrame: 12 and 24 months after inclusion
measure: Care path at the end of the visit
timeFrame: 12 and 24 months after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Nordic Pharma
Study officials:
affiliation: Nordic Pharma
name: Hélène HERMAN-DEMARS, MD
role: STUDY_DIRECTOR
affiliation: CHRU LILLE
name: René Marc FLIPO, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Nîmes
name: Cécile GAUJOUX-VIALA, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Le Mans
name: Emmanuelle DERNIS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Marseille
name: Éric SENBEL, Dr
role: PRINCIPAL_INVESTIGATOR
References: