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Discovering the Antecedents of Rheumatoid Arthritis Flare

Sponsor
Rockefeller University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02051114
Collaborator
(none)
25
Enrollment
1
Location
132
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    80% of patients living with rheumatoid arthritis can expect fluctuations in their symptoms over time. Dramatic increases in disease activity are considered flare. This study will follow patients with increased risk for flare prospectively for one year. Serial questionnaires and disease activity scores will be compared to blood samples to better understand the molecular phenotype of rheumatoid arthritis flares.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Discovering the Antecedents of Rheumatoid Arthritis Flare
    Study Start Date :
    Feb 1, 2014
    Anticipated Primary Completion Date :
    Feb 1, 2025
    Anticipated Study Completion Date :
    Feb 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. RNA transcripts that correlate with rheumatoid arthritis disease activity [1 year]

      Blood drawn at various times throughout one year will be correlated with fluctuations in RA disease activity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 2010 criteria for Rheumatoid Arthritis

    • Swelling of at least one joint and or elevated acute phase reactants

    • Greater than or equal to 40 years old or less than or equal to 65 year old female sex

    • cyclic citrullinated peptide antibody + in the past 12 months

    Exclusion Criteria:

    • hemoglobin < 9

    • white blood cell count < 3.5

    • Diagnosis of any active malignancy within the last 3 years besides non-melanomatous skin cancer

    • Diagnosis of diabetes and requires insulin

    • HIV+, Hep B S Ag+, Hep C polymerase chain reaction +

    • Untreated latent tuberculosis

    • Diagnosis of any additional systemic autoimmune connective tissue disease

    • Inability to reliably complete study requirements

    • History, physical, social or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Rockefeller University Hospital New York New York United States 10065

    Sponsors and Collaborators

    • Rockefeller University

    Investigators

    • Principal Investigator: Dana E Orange, MD, MS, The Rockefeller University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rockefeller University
    ClinicalTrials.gov Identifier:
    NCT02051114
    Other Study ID Numbers:
    • DOR-0833
    First Posted:
    Jan 31, 2014
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Rockefeller University
    Rheumatoid arthritis
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Apr 6, 2022