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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01101802

Acronym

MISSILE

Enrollment

Registered

2010-04-12

Start date

2006-03-31

Completion date

2008-10-31

Last updated

2011-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Systemic Lupus Erythematosus

Keywords

SLE, Atherosclerosis, Endothelial function, Mycophenolate mofetil

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).

Interventions

DRUGMycophenolate mofetil

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

DRUGsugar pill

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
BILAG, SLEDAI,	8 weeks	Measurements of disease activity in SLE

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026