E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic lupus erythematosus. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042944 |
E.1.2 | Term | Systemic lupus erythematosis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether Crestor will reduce the rate of progression of atherosclerosis in the carotid arteries of patients with systemic lupus erythematosus (SLE). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal exclusion criteria |
Patient age <18 years and >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 <60ml/min/1.73m2 or Stage 2).
Hyperlipidaemia (LDL>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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in bilateral carotid artery wall volume and distensibility as measured by MRI.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |