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

This study has been completed.
Sponsor:
Collaborators:
JSS Medical Research Inc.
Clinical Trial End-Point (CTEP) Ltd
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01078597
First received: March 1, 2010
Last updated: August 16, 2013
Last verified: August 2013
  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
Rheumatoid Arthritis

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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: September 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with early Rheumatoid Arthritis
Patients , aged 18 years or over, diagnosed with Rheumatoid Arthritis, with evidence of disease activity within the last year.

  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
Study Population

Patients with Rheumatoid Arthritis attending specialist rheumatology clinics.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078597

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
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
JSS Medical Research Inc.
Clinical Trial End-Point (CTEP) Ltd
Investigators
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: August 16, 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 April 17, 2014