Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
Condition: Lupus Erythematosus, Systemic
MeSH terms: Atherosclerosis; Lupus Erythematosus, Systemic
Intervention: Atorvastatin; Placebo atorvastatin
Intervention description: 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.
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 221.0
Sex: All
Minimum age: 10 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Pediatric lupus; Atherosclerosis; SLE; HMG CoA reductase inhibitor

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets American College of Rheumatology (ACR) revised diagnostic guidelines for SLE

          -  Weight of 25 kg (55 lbs) or more

          -  Outpatient

          -  Ability to complete self-report questionnaires in either English or Spanish

          -  Willingness to comply with recommended diet

          -  Acceptable methods of contraception

        Exclusion Criteria:

          -  Drug-induced lupus

          -  Liver disease (ALT or aspartate aminotransferase greater than 2 X normal value)

          -  Myositis (CK greater than 3 X normal value)

          -  Inability to obtain adequate-quality IMT images

          -  Current use of oral or parenteral tacrolimus or cyclosporine

          -  Dialysis or serum creatinine reater than 2.5 mg/dL

          -  Active nephrotic syndrome (urinary protein greater than 3 g/24 h and serum albumin
             less than 2.3 g/dl)

          -  Total cholesterol greater than 350 mg/dL

          -  Xanthoma

          -  Familial hypercholesterolemia

          -  Pregnant or breastfeeding

          -  Use of estrogen-containing contraceptives (e.g., Lo-Ovral)

          -  Unable to adhere to study regimen

          -  Life-threatening non-SLE illness that would interfere with ability to complete the
             study

          -  Current drug or alcohol abuse

          -  Anticipated poor compliance

          -  Participation in another drug intervention study within 30 days of study enrollment