IRAC: INCMNSZ - Rheumatoid Arthritis Cohort

• Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03389711
• Collaborator: (none)
• Enrollment: 237
• Location: 1
• Anticipated Duration (Months): 240
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early Rheumatoid Arthritis; Rheumatoid Arthritis	Combination Product: DMARD´s and multidisciplinary 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 Design

• Study Type: Observational
• Anticipated Enrollment: 237 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: INCMNSZ Early Rheumatoid Arthritis Cohort
• Actual Study Start Date: Feb 4, 2004
• Anticipated Primary Completion Date: Feb 4, 2024
• Anticipated Study Completion Date: Feb 4, 2024

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

5. 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.

6. 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

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City	Tlalpan	Mexico	14080

Sponsors and Collaborators

• National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

• Principal Investigator: Virginia Pascual, MD, INCMNSZ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Pascual Ramos, Lead Investigator of the Rheumatoid Arthritis Clinic, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• ClinicalTrials.gov Identifier: NCT03389711
• Other Study ID Numbers: IRE-274-10/11-1
• First Posted: Jan 4, 2018
• Last Update Posted: Apr 6, 2022
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Virginia Pascual Ramos, Lead Investigator of the Rheumatoid Arthritis Clinic, National Institute of Medical Sciences and Nutrition, Salvador Zubiran: Rheumatoid Arthritis Mexico; Early Rheumatoid Arthritis Cohort Mexico
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Apr 6, 2022