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

NCT01078597 | Completed

• 1 other identifier: P11-983
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

anti-MCV; anti-CCP; Biomarkers; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Anti-Cyclic Citrullinated Protein blood test results

  Baseline (Week 0), 6 months, 12 months

• Anti-Modified Citrullinated Vimentin blood test result

  Baseline Visit (Week 0)

• Rheumatoid Factor blood test result

  Baseline (Week 0), 6 months, 12 months

• Investigator Questionnaire assessing the impact (if any) of biomarker status on the management of the patient

  Baseline (Week 0), 6 months, 12 months

Secondary Outcomes (8)

• C- Reactive Protein (CRP) & Erythrocyte Sedimentation Rate (ESR) blood test results

  Baseline (Week 0), 6 months, 12months

• Swollen Joint Count

  Baseline (Week 0), 6 months, 12 months

• Tender Joint Count

  Baseline (Week 0), 6 months, 12 months

• Disease Activity Score (DAS)-28

  Baseline (Week 0), 6 months, 12 months

• Health Assessment Questionnaire Disability Index (HAQ-DI)

  Baseline (Week 0), 6 months, 12 months

Study Arms (1)

Patients with early Rheumatoid Arthritis

Patients , aged 18 years or over, diagnosed with Rheumatoid Arthritis, with evidence of disease activity within the last year.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Rheumatoid Arthritis attending specialist rheumatology clinics.

You may qualify if:

• 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

You may not qualify if:

• Patient's anti-CCP status (positive or negative) has not been determined.
• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• JSS Medical Research Inc.: collaborator
• Clinical Trial End-Point (CTEP) Ltd: collaborator

Study Sites (4)

Site Reference ID/Investigator# 49402

Cork, Ireland

Location

Site Reference ID/Investigator# 49403

Cork, Ireland

Location

Site Reference ID/Investigator# 22307

Dublin, Ireland

Location

Site Reference ID/Investigator# 72114

Dublin, Ireland

Location

Related Links

• Related Info

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.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Geraldine Mc Carthy

  Mater Misercordiae Hospital, Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

IE (4)