Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

Guy's and St Thomas' NHS Foundation Trust

Status and phase

Completed

Phase 4

Conditions

Atherosclerosis

Systemic Lupus Erythematosus

Treatments

Drug: sugar pill

Drug: Mycophenolate mofetil

Study type

Interventional

Funder types

Other

Identifiers

NCT01101802

WX18694

ISRCTN (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment

71 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No 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