A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)
- Conditions
- Atherosclerosis in patients with Systemic Lupus Erythematosis
- Registration Number
- EUCTR2005-001688-74-GB
- Lead Sponsor
- Guy's & St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method