Effect of anti-tumour necrosis factor alpha (TNFa) therapy on blood vessel health in patients with rheumatoid arthritis

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN57761809
• Lead Sponsor: niversity of Dundee (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Both males and females, 18 years old or over
2. Fulfil the 1987 American College of Rheumatology (ACR) classification criteria for rheumatoid arthritis
3. No exposure to anti-TNFa drugs in the last 3 months
4. Fulfil the National Institute for Clinical Excellence guidelines on the use of anti-TNFa drugs in rheumatoid arthritis* and be:
4.1. About to start etanercept or adalimumab (treatment group)
4.2. About to start methotrexate (control group)

* The patients in the control group must have had adequate therapeutic trial of at least one previous Disease Modifying Anti-Rheumatic Drug (DMARD) rather than two

Exclusion Criteria

1. Previous cardiovascular or cerebrovascular event in the last 3 years
2. Undergoing treatment for a cardiovascular risk factor except:
2.1. Patients with hypertension on stable medication for the last 3 months
2.2. Patients with hypercholesterolaemia on stable medication for the last 3 months

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial function measured by the following at baseline, 2 and 4 months: <br>1. Laser Doppler flowmetry after iontophoretic delivery of acetylcholine and sodium nitroprusside (microvascular) <br>2. Brachial artery flow mediated dilatation (macrovascular)

Secondary Outcome Measures

Name	Time	Method
The following were assessed at baseline, 2 and 4 months:<br>1. Endothelial function measured by blood testing of vascular function and damage (E selectin, <br> thrombomodulin)<br>2. Arterial stiffness measured by ultrasound echo tracking and applanation tonometry<br>3. Oxidative stress (Isoprostane levels)<br>4. RA disease activity (28-item Disease Activity Score [DAS28], Health Assessment Questionnaire [HAQ], 36-item Short Form health survey [SF-36])