Systemic lupus erythematosus Musculoskeletal Diseases Systemic lupus erythematosus
Conditions
Interventions
Comparing placebo and control groups of patients before and after eight weeks of taking the study medication. Parameters that will be compared include:
1. Systemic Lupus Erythematosus
Sponsors
Guy's and St Thomas' NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female systemic lupus erythematosus (SLE) patients 2. Age 18-50 years 3. Pre-menopausal, using a reliable method of contraception 4. Clinically stable disease 5. Taking hydroxychloroquine, prednisolone up to 15 mg per day or both
Exclusion criteria
Exclusion criteria: 1. Smokers 2. Pregnant or breast-feeding 3. Use of other immunosuppressants 4. Use of any investigational drug within one month prior to screening 5. Acute infections two weeks prior to visit 6. History of ischaemic heart disease or end stage renal failure 7. Current signs of severe hepatic, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of treatment with mycophenolate mofetil on endothelial function, measured by flow-mediated dilation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess any changes in disease activity measured by SLEDAI and BILAG 2. To measure any changes in lupus serology and bio-markers of cardiovascular disease 3. To measure any changes in arterial stiffness using ankle-brachial index and pulse wave analysis | — |
Countries
United Kingdom
Outcome results
None listed