Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate

Phase 1

Conditions: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory polyarthritis associated with excess cardiovascular (CV) mortality. Hyperhomocysteinaemia is recognized as an independent CV risk factor and homocysteine levels are frequently elevated in RA patients.Endothelial dysfunction is considered a marker of early atherosclerotic disease and seems to correlate well with future increase CV risk. RA patients are known to have endothelial dysfunction.

Registration Number: EUCTR2005-000551-15-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

a/ Fulfill the 1987 American College of Rheumatology classification criteria for rheumatoid arthritis.
b/ Due to be started on methotrexate by the rheumatology team in Tayside
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a/ Previous cardiovascular or cerebrovascular events
b/ Undergoing treatment for a cardiovascular risk factor
c/ Contraindications to allopurinol:
- moderate to severe renal impairment
- liver impairment
- concominant treatmenmt with azathioprine
- known allegy to allopurinol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to assess the effect of Methotrexate on endothelial function and other surrogate markers for CV disease in patients with RA. We want to understand whether Methotrexate improves endothelial function by its anti-inflammatory effect or whether the negative influence of hyperhomocysteinaemia on the endothelium is what prevails. ;Secondary Objective: We also plan to assess whether counteracting the raise in homocysteine levels by added Folic Acid supplementation translates into an improvement in endothelial function. As a final objective we aim to further improve the endothelial function by reducing free radical production with Allopurinol. ;Primary end point(s): Endothelial function measured by laser Doppler flowmetry with Iontophoresis and by brachial artery flow mediated dilatation

Secondary Outcome Measures