Systemic lupus erythematosus. MedDRA version: 13.1 Level: LLT Classification code 10042944 Term: Systemic lupus erythematosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Crestor
Product Name: Crestor
Pharmaceutical Form: Tablet
INN or Proposed INN: ROSUVASTATIN CALCIUM
CAS Number: 147098-20-2
Sponsors
Imperial College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with SLE – as diagnosed by American College Rheumatology (ACR) criteria. Male or female subjects who were 18 to 80 years of age, inclusive, at screening. Female subjects who are post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or using effective contraceptive measures (oral contraceptives, Norplant Depo-Provera, intra-uterine devices (IUD), a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential are to use effective contraceptive measures for at least one month prior to Visit 0 (screening), and continue to use the same contraceptive method during the study and for 30 days after discontinuing study treatment. No current or previous statin therapy. No current indication for statin therapy (such as known coronary artery disease, hypercholesterolaemia, renal dysfunction with eGFR = 59ml/min/1.73m2). Subjects with a raised CK or raised LFTs where, in the opinion of the treating SLE physician (Rheumatologist), the test abnormality is minor and/or has an explanation that is not a contraindication to the use of a statin. Subjects who had given their signed informed consent to participation in the study. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient age 80 years. Contraindications to MRI- patients with pacemakers, defibrillators or pacing wires in the heart, or other metal implants such as metal in the eye, brain or spine. Other metallic devices or implants will have to be declared by the participant and assessed to be safe prior to having a MRI. All participants will have to adhere to and sign a Royal Brompton Hospital safety checklist prior to having a MRI. Current or previous statin therapy. Known atherosclerotic vascular disease (known ischaemic heart disease, cerebrovascular disease, peripheral vascular disease). Renal dysfunction (estimated creatinine clearance 3.4 mmol/L on fasting lipid profile) Active myositis / CK >150 IU/L except where, in the opinion of the treating SLE physician (Rheumatologist), the test abnormality is minor and/or has an explanation that is not a contraindication to the use of a statin. All forms of liver disease (AST/ALT > 1.5x normal) except where, in the opinion of the treating SLE physician (Rheumatologist), the test abnormality is minor and/or has an explanation that is not a contraindication to the use of a statin. Pregnancy- patients must agree in writing to maintain effective contraception throughout the course of the trial. Statins are contraindicated in pregnancy. Breastfeeding. Patients who are being treated with Cyclosporin A.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change from baseline in bilateral carotid artery wall volume and distensibility as measured by MRI. ; Secondary Objective: To determine whether Crestor will improve endothelial function in patients with SLE. To assess cardiac structure function and fibrosis in patients with SLE and to whether function changes after administration of rosvastatin. ;Main Objective: To determine whether Crestor will reduce the rate of progression of atherosclerosis in the carotid arteries of patients with systemic lupus erythematosus (SLE). | — |
Countries
United Kingdom
Outcome results
None listed