A Study on the Prevalence of the Modified Citrullinated Vimentin Anti-body (Anti-MCV) in an Irish Rheumatoid Arthritis (RA) Population and to Assess the Impact of Anti-MCV and the Anti-cyclic-citrullinated Peptide Antibody (Anti-CCP) Status on the Management of Irish Patients With Early RA

Study Identifier
P11-983
CT.gov Identifier
NCT01078597
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patient is 18 years of age or older. * Patient was diagnosed with Rheumatoid Arthritis with evidence of disease activity within the past year. * Patient has known anti-CCP status (positive or negative). * Patient has agreed to participate in the study by signing an informed consent. * Patient will be available for a period of follow-up of 12 months, from the time of enrollment in the study * Patient is fluent in the English language
    Exclusion Criteria:
    * Patient's anti-CCP status (positive or negative) has not been determined. * Patient with any other rheumatological disorder such as mixed connective tissue disease, psoriatic arthritis, ankylosing spondylitis, scleroderma and crystal induced arthropathies. Osteoarthritis is not an exclusion criterion. * Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation. * Patient is not willing to sign an informed consent

    Protocol Summary

    A key challenge in the management of patients with Rheumatoid Arthritis (RA) is the early identification of patients that are at risk of developing a severe and destructive disease. A better understanding of prognostic factors such as anti-CCP and anti-MCV biomarkers, is needed in order to better identify patients with early Rheumatoid Arthritis that are at risk of developing aggressive diseases. At the present time the prevalence of one such biomarker, namely anti-MCV, is unknown in an Irish Rheumatoid Arthritis population. This study will establish the prevalence of anti-MCV in such a population.

    A second challenge in the management of Rheumatoid Arthritis patients is the determination of the best treatment strategy tailored to individual patient's needs. In routine practice, treatment approaches are based on the patient history and the availability of clinical parameters, such as a positive anti-CCP status, which is associated with worst prognostics. At the present time, the impact of a positive anti-CCP status on patients' management has not been formally studied in Ireland The proposed study will provide data on the prevalence of anti-MCV in an Irish RA population and the use of anti-CCP and other clinical parameters currently used in routine care. In addition, the present study will evaluate the impact of the known anti-CCP status on patients' management. Associations between the anti-CCP and anti-MCV status and clinical outcome measures will be assessed.

    The results from the present study will have significant implications not only for the individual patient but also from the societal perspective, since it will enhance the overall understanding and applications of different treatment approaches based on individual patients' profile.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 49402
    Cork, Ireland
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 49403
    Cork, Ireland
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 22307
    Dublin, Ireland
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 72114
    Dublin, Ireland
    Status
    Not applicable