INCMNSZ - Rheumatoid Arthritis Cohort

• Conditions: Rheumatoid Arthritis; Early Rheumatoid Arthritis

• Registration Number: NCT03389711
• Lead Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

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

Study Timeline

• Study Start: 2004-02-04
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-26
• Study First Posted: 2018-01-04
• Status Verified: 2021-08
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06
• Primary Completion: 2024-02-04
• Study Completion: 2024-02-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 237

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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.

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Tlalpan, Mexico