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

Effect of anti-tumour necrosis factor alpha (TNFa) therapy on endothelial function and other surrogate markers of cardiovascular disease in patients with rheumatoid arthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN57761809

Enrollment

Registered

2008-05-09

Start date

2006-02-10

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis

Interventions

This is an observational study. The drugs are prescribed by the rheumatology team, and this study assesses the impact of those drugs on blood vessel health. 90 RA patients (30 due to be started on

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026