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UnknownNCT03389711

INCMNSZ - Rheumatoid Arthritis Cohort

INCMNSZ Early Rheumatoid Arthritis Cohort

Status
Unknown
Phase
Study type
Observational
Enrollment
237 (estimated)
Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTDMARD´s and multidisciplinary treatmentAt 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).

Timeline

Start date
2004-02-04
Primary completion
2024-02-04
Completion
2024-02-04
First posted
2018-01-04
Last updated
2022-04-06

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT03389711. Inclusion in this directory is not an endorsement.