Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

Guy's and St Thomas' NHS Foundation Trust71 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Systemic Lupus Erythematosus Atherosclerosis

Interventions

Mycophenolate mofetilDRUG

Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.

sugar pillDRUG

Arm 2 patients were given 2 sugar pills bd for 8 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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: * Smokers * 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

Locations (1)

Lupus Research Unit, St Thomas' Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Flow mediated dilation

Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.

Time frame: 8 weeks

Secondary Outcomes

BILAG, SLEDAI,

Measurements of disease activity in SLE

Time frame: 8 weeks

Data from ClinicalTrials.gov

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