Atherosclerosis in patients with Systemic Lupus Erythematosis
Conditions
Interventions
Trade Name: CellCept
Product Name: Mycophenolate mofetil
Product Code: Ro 106-1443
Pharmaceutical Form: Tablet
INN or Proposed INN: Myco
Sponsors
Guy's & St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Female SLE patients 2) Age 18-50 years 3) Premenopausal using a reliable method of contraception 4) Clinically stable disease 5) Taking hydroxychloroquine and up to 15mgs of prednisolone daily Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Smokers 2) Pregnancy or breast feeding 3) Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted) 4) Use of any investigational drug within 1 month prior to screening 5) Acute infections 2 weeks prior to Visit 1 6) History of ischaemic heart disease or end stage renal disease 7) Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does Mycophenalote Mofetil, an immunosuppressant, have an effect on the surrogate markers for cardiovascular disease in patients with the autoimmune disease systemic lupus erythematosus?;Secondary Objective: Confirmation that mycophenolate mofetil is well tolerated in patients with systemic lupus erythematosus.;Primary end point(s): To assess the effect of treatment with mycophenolate mofetil on endothelium function measured by flow mediated dilation. | — |
Countries
United Kingdom
Outcome results
None listed