Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laura Schanberg
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxychloroquine

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