Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

Phase 4

Completed

• Conditions: Systemic Lupus Erythematosus; Atherosclerosis
• Interventions: Drug: sugar pill; Drug: Mycophenolate mofetil

• Registration Number: NCT01101802
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-05
• Study Start: 2006-03
• Primary Completion: 2008-03
• Study Completion: 2008-10
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-09
• Study First Posted: 2010-04-12
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	sugar pill	-
Mycophenolate mofetil	Mycophenolate mofetil	Patients were given 1gm bd mycophenolate mofetil for 8 weeks

Primary Outcome Measures

Name	Time	Method
Flow mediated dilation	8 weeks	Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.

Secondary Outcome Measures

Name	Time	Method
BILAG, SLEDAI,	8 weeks	Measurements of disease activity in SLE

Trial Locations

Locations (1)

Lupus Research Unit, St Thomas' Hospital; 🇬🇧 London, United Kingdom