Early Rheumatoid Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis Mexico, Early Rheumatoid Arthritis Cohort Mexico
Brief summary
Identify Rheumatoid Arthritis patients diagnose within first 12 months since the beginning of the disease related symptoms. Initiate proper treatment according to international standards in order to achieve remission/low disease activity status.
Detailed description
* Provide an standardized follow up by a multidisciplinary specialized team. * Create a biological (blood) bank to develop future research projects. * Create a database with the clinical, serologic, radiographic and functional status patients data. * Define comorbidities and mortality causes. * Begin an educational program to improve patient disease self-knowledge
Interventions
COMBINATION_PRODUCTDMARD´s and multidisciplinary treatment
At study enrollment, medical history, disease-specific autoantibodies, ACR 1987 classification criteria for RA were applied. Medical evaluations were standardized and included at least 66 swollen and 68 tender joint counts, acute reactant-phase determinations , patient and physician reported outcomes, comorbidity established by record review, and treatment assessments (name, dose and schedule of all drug they were taking) along with an evaluation of persistence, at six-month intervals. Patients were evaluated by a single rheumatologist every two months during the first two years of follow-up, and every two, four or six months thereafter. Also the following scores: Michigan Hand Outcome Questionnaire (MHQ), Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH),Mayor Depressive Episodes (MDE) was defined using the Mini International Neuropsychiatric Interview and the severity of depressive symptoms was assessed with the Beck Depression Inventory (BDI-II).
Sponsors
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old * Fulfilled ACR 1987 classification criteria for RA * Disease evolution of \<1 year when first evaluated, and no specific rheumatic diagnosis except for RA.
Exclusion criteria
* Patients with another rheumatic disease, except Sjögren syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity status | During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status. | Describe the disease activity score using DAS 28 ESR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline of the Patient Reported Outcome: RADAI (Rheumatoid Arthritis Disease Activity Index) | During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status. | To describe the changes in every visit in the RADAI score |
| Change from Baseline of the Patient Reported Outcome : SF-36 (Short Form Health Survey) | During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status. | To describe the changes in every visit in the SF-36 score |
| Predictors of health care drop-out | During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status. | Identify and describe patients from an inception ongoing cohort with recent onset RA at inclusion, who dropped out of health care during their follow-up |
| Change from Baseline of the Patient Reported Outcome : HAQ (Health Assessment Questionnarie) | During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status. | To describe the changes in every visit in the HAQ score |
| Michigan Hand Outcome Questionnarie (MHQ | During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status. | To assess a variety of hand and upper extremity injuries related to Rheumatoid Arthritis |
| Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH) | During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status. | To measure upper-extremity disability and symptoms |
| Mayor Depressive Episodes (MDE) | During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status. | Investigate associations between major depressive episodes (MDE), concordance with therapy (CwT) and disease outcomes in rheumatoid arthritis patients. |
Countries
Mexico
Contacts
Primary ContactVirginia Pascual, MD
Backup ContactIrazú Contreras, Msc
Outcome results
None listed