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

Study Overview
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Brief Summary
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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.

Official Title
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Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main criteria analysis | Same Outcome 1, but at 24 month. This outcome is blinded too. | 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 ... | 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)) | 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). | 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). | 12 and 24 months after inclusion | 
| Functional capacity (Health Assessment Questionnaire (HAQ)) | This questionnaire is completed by patients at baseline, 12 months and 24 months. | 12 and 24 months after inclusion | 
| Cross-perception (doctor / patient) about participation in the shared medical decision | This outcome is based on 2 mirror questions (one asked to the physician and on to the patient). They are asked if the decision to adapt the therapeutic decision is a shared medical decision. Five answers are possible from fully to not at all. | 12 and 24 months after inclusion | 
| Care path at the end of the visit | The physician is asked about the patient pathway (How and by whom the patient will be followed : nurse, other physicians) | 12 and 24 months after inclusion |