STRATEGE2: Therapeutic Strategy Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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 ...
- 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))
- 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).
- 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).
- 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.
- 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".
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Major patient (age ≥ 18 years)
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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
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Patient undergoing treatment with methotrexate (MTX) (oral or injectable) initiated for at least 3 months.
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Naïve patient of biotherapy or tsDMARD and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease.
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Patient informed and accepting the computer processing of his/her medical data and informed of his/her rights of access and rectification.
Exclusion Criteria:
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Patient participating in an interventional study in rheumatology
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Patient with axial spondyloarthritis (for patients with PsA)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nordic Pharma | Paris | France | 75007 |
Sponsors and Collaborators
- Nordic Pharma SAS
Investigators
- Study Director: Hélène HERMAN-DEMARS, MD, Nordic Pharma
- Principal Investigator: René Marc FLIPO, Prof, CHRU Lille
- Principal Investigator: Cécile GAUJOUX-VIALA, Dr, CHU Nîmes
- Principal Investigator: Emmanuelle DERNIS, Dr, CH Le Mans
- Principal Investigator: Éric SENBEL, Dr, Marseille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STRATEGE 2