|
Welcome
|
|
13 May 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Effect of anti-tumour necrosis factor alpha (TNFα) therapy on blood vessel health in patients with rheumatoid arthritis |
| ISRCTN | ISRCTN57761809 |
| ClinicalTrials.gov identifier | |
| Public title | Effect of anti-tumour necrosis factor alpha (TNFα) therapy on blood vessel health in patients with rheumatoid arthritis |
| Scientific title | Effect of anti-tumour necrosis factor alpha (TNFα) therapy on endothelial function and other surrogate markers of cardiovascular disease in patients with rheumatoid arthritis |
| Acronym | N/A |
| Serial number at source | ETADA90 v1 |
| Study hypothesis |
Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disorder characterized by a symmetrical erosive polyarthritis with inflammatory multisystemic involvement. Most patients exhibit a chronic fluctuating course of disease that, if left untreated, results in progressive joint destruction, deformity, and disability. The patient with RA has their life span shortened by 15-20%, with 34-40% of excess deaths being due to cardiovascular disease.
Study aim: To assess the effect of the TNFa blocking drug etanercept and adalimumab on endothelial dysfunction and other surrogate markers of cardiovascular diseases in patients with RA. We hypothesised that the biologic drugs have the potential to improve endothelial dysfunction and other surrogate markers of cardiovascular disease (CVD) in patients with RA. We believe that if etanercept and adalimumab can improve endothelial dysfunction in RA patients they may be able to reduce the cardiovascular morbidity and mortality seen in this group of patients. |
| Ethics approval | Tayside Committee on Medical Research Ethics. Date of approval: 05/09/2005 (ref: 05/S1401/112) |
| Study design | Observational, open-label, single-centre study. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Rheumatoid arthritis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 10/02/2006 |
| Anticipated end date | 25/04/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 90 |
| 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 methotrexate, 30 due to be started on etanercept and 30 due to be started on adalimumab) will be recruited from rheumatology clinics throughout Tayside. Treatment allocation (etanercept, adalimumab or methotrexate) will be decided by the rheumatologists in the clinic. The drugs are normally prescribed as: Etanercept: Subcutaneous injections 25 mg twice a week or 50 mg once a week Adalimumab: Subcutaneous injections 40 mg every other week Methotrexate: Orally once a week. Doses range from 7.5 mg a week to 25 mg a week Surrogate markers of cardiovascular disease will be measured at baseline (before commencement of methotrexate/ etanercept/ adalimumab), 2 months and at 4 months. |
| Primary outcome measure(s) |
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 outcome measure(s) |
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]) |
| Sources of funding | Wyeth Pharmaceuticals (protocol ref: 102062) (USA) |
| Trial website | |
| Publications | |
| Contact name | Prof Jill Belch |
| Address |
Vascular and Inflammatory Diseases Research Unit
The Institute of Cardiovascular Research University Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee |
| City/town | Dundee |
| Zip/Postcode | DD1 9SY |
| Country | United Kingdom |
| Tel | +44 (0)1382 632457 |
| Fax | +44 (0)1382 632333 |
| j.j.f.belch@dundee.ac.uk | |
| Sponsor | University of Dundee (UK) |
| Address | Research and Innovation Services |
| City/town | Dundee |
| Zip/Postcode | DD1 4HN |
| Country | United Kingdom |
| Tel | +44 (0)1382 344664 |
| Fax | +44 (0)1382 202178 |
| j.z.houston@dundee.ac.uk | |
| Sponsor website: | http://www.dundee.ac.uk |
| Date applied | 07/04/2008 |
| Last edited | 09/05/2008 |
| Date ISRCTN assigned | 09/05/2008 |
 |
|||
|
|
|
| © ISRCTN | |
|
|
|
|