INCMNSZ - Rheumatoid Arthritis Cohort

Study Overview
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Brief Summary
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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
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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

Official Title
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INCMNSZ Early Rheumatoid Arthritis Cohort

Conditions
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Early Rheumatoid Arthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Combination Product: DMARD´s and multidisciplinary treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: DMARD´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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity status | Describe the disease activity score using DAS 28 ESR | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of the Patient Reported Outcome : HAQ (Health Assessment Questionnarie) | To describe the changes in every visit in the HAQ score | 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. | 
| Change from Baseline of the Patient Reported Outcome: RADAI (Rheumatoid Arthritis Disease Activity Index) | To describe the changes in every visit in the RADAI score | 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. | 
| Change from Baseline of the Patient Reported Outcome : SF-36 (Short Form Health Survey) | To describe the changes in every visit in the SF-36 score | 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. | 
| Predictors of health care drop-out | 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 | 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. | 
| Mayor Depressive Episodes (MDE) | Investigate associations between major depressive episodes (MDE), concordance with therapy (CwT) and disease outcomes in rheumatoid arthritis patients. | 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. | 
| Michigan Hand Outcome Questionnarie (MHQ | To assess a variety of hand and upper extremity injuries related to Rheumatoid Arthritis | 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. | 
| Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH) | To measure upper-extremity disability and symptoms | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis Mexico, Early Rheumatoid Arthritis Cohort Mexico