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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis |
Other: This is a non-drug study. No treatment is mandated by the protocol. Routine blood draws (as per normal clinical care) will be taken through the study. |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Anti-Cyclic Citrullinated Protein blood test results [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- Anti-Modified Citrullinated Vimentin blood test result [ Time Frame: Baseline Visit (Week 0) ] [ Designated as safety issue: No ]
- Rheumatoid Factor blood test result [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- Investigator Questionnaire assessing the impact (if any) of biomarker status on the management of the patient [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- C- Reactive Protein (CRP) & Erythrocyte Sedimentation Rate (ESR) blood test results [ Time Frame: Baseline (Week 0), 6 months, 12months ] [ Designated as safety issue: No ]
- Swollen Joint Count [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- Tender Joint Count [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- Disease Activity Score (DAS)-28 [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- Visual Analogue Scale-Disease Activity (VAS-DA) [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- Visual Analogue Scale - Pain (VAS-Pain) [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
- Visual Analogue Scale - General Health (VAS-GH) [ Time Frame: Baseline (Week 0), 6 months, 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
There are no biospecimens specifically retained for the purposes of the study. Routine blood samples may be retained as per routine practice of the participating centre.
| Estimated Enrollment: | 35 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients with early Rheumatoid Arthritis
Patients , aged 18 years or over, diagnosed with Rheumatoid Arthritis, with evidence of disease activity within the last year.
|
Other: This is a non-drug study. No treatment is mandated by the protocol. Routine blood draws (as per normal clinical care) will be taken through the study.
No specific treatment is mandated by the protocol. Treatment is as per investigator judgement.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Rheumatoid Arthritis attending specialist rheumatology clinics.
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
Contacts and Locations| 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, Ireland | |
| Principal Investigator: | Geraldine Mc Carthy | Mater Misercordiae Hospital, Dublin |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01078597 History of Changes |
| Other Study ID Numbers: | P11-983 |
| Study First Received: | March 1, 2010 |
| Last Updated: | March 18, 2013 |
| Health Authority: | Ireland: Medical Ethics Research Committee |
Keywords provided by AbbVie:
|
anti-MCV anti-CCP Biomarkers Rheumatoid Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013