NCT01101802

Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Lupus Erythematosus
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil	Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.
DRUG	sugar pill	Arm 2 patients were given 2 sugar pills bd for 8 weeks

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-03-01
• Completion: 2008-10-01
• First posted: 2010-04-12
• Last updated: 2011-09-28

Locations

1 site across 1 country: United Kingdom