NCT01101802
Completed
Phase 4
A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.
Overview
- Phase
- Phase 4
- Intervention
- Mycophenolate mofetil
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Flow mediated dilation
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis. Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug mycophenolate mofetil (MMF).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female SLE patients
- •Age 18-60 years
- •If premenopausal using a reliable method of contraception
- •Clinically stable disease
- •Taking hydroxychloroquine and up to 15mgs of prednisolone daily
Exclusion Criteria
- •Pregnancy or breast feeding
- •Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
- •Use of any investigational drug within 1 month prior to screening
- •Acute infections 2 weeks prior to Visit 1
- •History of ischaemic heart disease or end stage renal disease
- •Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease
Arms & Interventions
Mycophenolate mofetil
Patients were given 1gm bd mycophenolate mofetil for 8 weeks
Intervention: Mycophenolate mofetil
Sugar pill
Intervention: sugar pill
Outcomes
Primary Outcomes
Flow mediated dilation
Time Frame: 8 weeks
Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.
Secondary Outcomes
- BILAG, SLEDAI,(8 weeks)
Study Sites (1)
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