CompletedPhase 3

Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)

United States221 participantsStarted 2003-09

Plain-language 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).

Who can participate

Age range10 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Mean-Mean Common Carotid IMT (CIMT)

Timeframe: Change from baseline to 36 months

Trial details

NCT IDNCT00065806

SponsorLaura Schanberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12

Results submitted2013-02-11