Therapeutic Strategy Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis

Nordic Pharma SAS400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Rheumatoid Arthritis Psoriatic Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Nordic Pharma

Paris, France

Outcomes

Primary Outcomes

The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.

Not provided as Outcome 1 is blinded

Time frame: 12 months after inclusion

Secondary Outcomes

Main criteria analysis

Same Outcome 1, but at 24 month. This outcome is blinded too.

Time frame: 24 months after inclusion

Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids

delays, changes in dosage, changes in the route of administration, reasons for adaptations ...

Time frame: 12 and 24 months after inclusion

Disease outcome

disease activity (Disease Activity Score DAS28 and Disease Activity in PSoriatic Arthritis DAPSA)), percentage of patients in remission, quality of Life (Dermatology Life Quality Index (DLQI))

Time frame: 12 and 24 months after inclusion

Patient adherence to treatment

The variation of patients' adherence to antirheumatic treatments evaluated by the Compliance Questionnaire for Rhumatology (CQR19).

Time frame: 12 and 24 months after inclusion

Fatigue and pain

Visual Analog Scale (VAS) anchored by 2 verbal descriptors, one for each symptom extreme : 0 (no fatigue, no pain) to 10 (maximum fatigue, maximum pain).

Time frame: 12 and 24 months after inclusion

Functional capacity (Health Assessment Questionnaire (HAQ))

Data from ClinicalTrials.gov

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