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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hélène HERMAN-DEMARS, MD | Nordic Pharma | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordic Pharma | Paris | 75007 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41335306 | Derived | Gaujoux-Viala C, Dernis E, Senbel E, Herman-Demars H, Becker J, Flipo RM. Methotrexate Maintenance After Initiation of Biological or Targeted Synthetic DMARDs in Rheumatoid Arthritis: Results from the 2-Year Longitudinal Prospective Non-interventional STRATEGE2 Study. Rheumatol Ther. 2026 Feb;13(1):157-177. doi: 10.1007/s40744-025-00806-1. Epub 2025 Dec 3. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |