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Trial record 2 of 1187 for:    Recruiting, Not yet recruiting, Available Studies | "Arthritis"

INCMNSZ - Rheumatoid Arthritis Cohort (IRAC)

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ClinicalTrials.gov Identifier: NCT03389711
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Pascual Ramos, 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.

Condition or disease Intervention/treatment
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 Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: INCMNSZ Early Rheumatoid Arthritis Cohort
Actual Study Start Date : February 4, 2004
Estimated Primary Completion Date : February 4, 2019
Estimated Study Completion Date : February 4, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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).



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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


Biospecimen Retention:   Samples With DNA
Blood samples to asses serological status (rheumatoid arthritis antibodies)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389711


Contacts
Contact: Virginia Pascual, MD 00525555734111 virtichu@gmail.com
Contact: Irazú Contreras, Msc 00525555734111 protocolosar@live.com

Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Tlalpan, Mexico, 14080
Contact: Virginia Pascual, MD       virtichu@gmail.com   
Sponsors and Collaborators
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Investigators
Principal Investigator: Virginia Pascual, MD INCMNSZ

Publications of Results:

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     History of Changes
Other Study ID Numbers: IRE-274-10/11-1
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is undecided yet.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran:
Rheumatoid Arthritis Mexico
Early Rheumatoid Arthritis Cohort Mexico

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases