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

• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

• Registration Number: NCT05082805
• Lead Sponsor: Nordic Pharma SAS

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-02-25
• Study First Submitted: 2019-06-24
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-14
• Last Update Submitted: 2021-10-14
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies.	12 months after inclusion	Not provided as Outcome 1 is blinded

Secondary Outcome Measures

Name	Time	Method
Functional capacity (Health Assessment Questionnaire (HAQ))	12 and 24 months after inclusion	This questionnaire is completed by patients at baseline, 12 months and 24 months.
Care path at the end of the visit	12 and 24 months after inclusion	The physician is asked about the patient pathway (How and by whom the patient will be followed : nurse, other physicians)
Disease outcome	12 and 24 months after inclusion	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))
Fatigue and pain	12 and 24 months after inclusion	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).
Cross-perception (doctor / patient) about participation in the "shared medical decision"	12 and 24 months after inclusion	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".
Patient adherence to treatment	12 and 24 months after inclusion	The variation of patients' adherence to antirheumatic treatments evaluated by the Compliance Questionnaire for Rhumatology (CQR19).
Main criteria analysis	24 months after inclusion	Same Outcome 1, but at 24 month. This outcome is blinded too.
Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids	12 and 24 months after inclusion	delays, changes in dosage, changes in the route of administration, reasons for adaptations ...

Trial Locations

Locations (1)

Nordic Pharma; 🇫🇷 Paris, France