INCMNSZ - Rheumatoid Arthritis Cohort (IRAC)

April 4, 2022 updated by: Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

INCMNSZ Early Rheumatoid Arthritis Cohort

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

237

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) belongs to the National Institutes of Health of México. Patients enrolled in the Early arthritis cohort had a disease duration of <1 year when first evaluated, and no specific rheumatic diagnosis except for RA. Patients had partial health coverage and paid for their physician's consultations, laboratory investigations and for their treatment that was prescribed by the rheumatologist in charge of the clinic, and was "treat to target" oriented.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity status
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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.
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
Time Frame: 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
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)
Time Frame: 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

  • Principal Investigator: Virginia Pascual, MD, INCMNSZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2004

Primary Completion (Anticipated)

February 4, 2024

Study Completion (Anticipated)

February 4, 2024

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

December 26, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRE-274-10/11-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

It is undecided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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