Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

Study Overview
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Brief Summary
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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).

Official Title
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A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.

Conditions
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Systemic Lupus Erythematosus, Atherosclerosis

Intervention / Treatment
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* Drug: Mycophenolate mofetil
* Drug: sugar pill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mycophenolate mofetil<br>Patients were given 1gm bd mycophenolate mofetil for 8 weeks | Drug: Mycophenolate mofetil<br>* Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.<br>* Other names: Cellcept;|
| Placebo Comparator: Sugar pill<br> | Drug: sugar pill<br>* Arm 2 patients were given 2 sugar pills bd for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilation | Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BILAG, SLEDAI, | Measurements of disease activity in SLE | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, Atherosclerosis, Endothelial function, Mycophenolate mofetil