At a glance
ClinicalIndex Comparison Record- ✓Meets American College of Rheumatology (ACR) revised diagnostic guidelines for SLE
- ✓Weight of 25 kg or more
- ✓Outpatient status
- ✓Ability to complete self-report questionnaires in either English or Spanish
- ✕Drug-induced lupus
- ✕Liver disease (ALT or aspartate aminotransferase greater than 2 × normal value)
- ✕Myositis (CK greater than 3 × normal value)
- ✕Inability to obtain adequate-quality IMT images
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Test the Safety and Efficacy of Lipitor (Atorvastatin) in Reducing the Progression of Carotid IMT in Early Childhood SLE
In Brief
A Phase 3 clinical trial evaluating Atorvastatin and Placebo atorvastatin for Lupus Erythematosus, Systemic. Completed, enrolled 221 participants across 1 site.
Detailed Summary
The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2. To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin. 3. To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively. 4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).
Study Details
Timeline
Interventions
Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.
Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months.