Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborator: Institute of Child Health, University College London, London, UK.
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

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