Rheumatoid Arthritis Clinical Trial
Official title:
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
Verified date | August 2013 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ireland: Medical Ethics Research Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Ireland | Site Reference ID/Investigator# 49402 | Cork | |
Ireland | Site Reference ID/Investigator# 49403 | Cork | |
Ireland | Site Reference ID/Investigator# 22307 | Dublin 24 | |
Ireland | Site Reference ID/Investigator# 72114 | Dublin 4 |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) | Clinical Trial End-Point (CTEP) Ltd, JSS Medical Research Inc. |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-Cyclic Citrullinated Protein blood test results | Baseline (Week 0), 6 months, 12 months | No | |
Primary | Anti-Modified Citrullinated Vimentin blood test result | Baseline Visit (Week 0) | No | |
Primary | Rheumatoid Factor blood test result | Baseline (Week 0), 6 months, 12 months | No | |
Primary | Investigator Questionnaire assessing the impact (if any) of biomarker status on the management of the patient | Baseline (Week 0), 6 months, 12 months | No | |
Secondary | C- Reactive Protein (CRP) & Erythrocyte Sedimentation Rate (ESR) blood test results | Baseline (Week 0), 6 months, 12months | No | |
Secondary | Swollen Joint Count | Baseline (Week 0), 6 months, 12 months | No | |
Secondary | Tender Joint Count | Baseline (Week 0), 6 months, 12 months | No | |
Secondary | Disease Activity Score (DAS)-28 | Baseline (Week 0), 6 months, 12 months | No | |
Secondary | Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline (Week 0), 6 months, 12 months | No | |
Secondary | Visual Analogue Scale-Disease Activity (VAS-DA) | Baseline (Week 0), 6 months, 12 months | No | |
Secondary | Visual Analogue Scale - Pain (VAS-Pain) | Baseline (Week 0), 6 months, 12 months | No | |
Secondary | Visual Analogue Scale - General Health (VAS-GH) | Baseline (Week 0), 6 months, 12 months | No |
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