Rheumatoid Arthritis Clinical Trial
— STRATEGEOfficial title:
Therapeutic Strategy in Rheumatology When Faced With a Patient Treated With Methotrexate (MTX) for Rheumatoid Arthritis (RA).
This is a longitudinal, observational, prospective, multicentre study conducted in
metropolitan France, among a representative sample of office-based or mixed practice
rheumatology doctors.
The aim of this study is to describe in real life, the therapy strategy when faced with a
patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and
the impact on the progression of the disease at 6 months.
Status | Completed |
Enrollment | 854 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patient, ambulatory, seen in a rheumatology consultation. - With a confirmed diagnosis of RA (ACR 1987 or ACR/EULAR 2010 criteria) receiving a disease-modifying treatment with methotrexate as a monotherapy. - With clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the RA . - Informed about the computer processing of their medical data and their right of access and correction. Exclusion Criteria: - Patient not treated with methotrexate for their RA. - Already treated with a biotherapy or receiving other synthetic DMARDs (disease-modifying antirheumatic drugs) in combination with methotrexate . - Participating in a clinical trial in rheumatology. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Nordic Pharma | Paris |
Lead Sponsor | Collaborator |
---|---|
Nordic Pharma SAS |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28) | The distribution of the various therapeutic options will be described overall. Their impact on the progression of the RA will be assessed at 6 months according to the EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28) score during the study) | Patients are included at the time of the change in the treatment of the RA and followed up to 6 months | No |
Secondary | Patient's satisfaction using a 4-point verbal scale | Satisfaction will be assessed using a 4-point verbal scale. | 6 months after inclusion | No |
Secondary | Medical economic aspect (cost/benefit ratio) | The cost/benefit ratio of each therapeutic strategy will be described. | 6 months after inclusion | No |
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