Phase 3 N=221 Randomized Double-blind Treatment

Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)

Lupus Erythematosus, Systemic

Bottom Line

View on ClinicalTrials.gov: NCT00065806 ↗

Enrolled (actual)

221

Serious AEs

33.5%

Results posted

Aug 2013

Primary outcome: Primary: Change in Mean-Mean Common Carotid IMT (CIMT) — 0.0010; 0.0024 mm

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Atorvastatin (Drug); Placebo atorvastatin (Drug)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Laura Schanberg
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean-Mean Common Carotid IMT (CIMT)	0.0010; 0.0024	—
SECONDARY Change in Mean-Max CIMT	0.0037; 0.0064	—
SECONDARY Change in Mean-Mean CIMT	0.0033; 0.0049	—
SECONDARY Change in Mean-Max Common CIMT	0.0006; 0.0008	—
SECONDARY Change in Mean-Max Internal CIMT	0.0090; 0.0144	—
SECONDARY Change in Mean-Mean Internal CIMT	0.0067; 0.0082	—
SECONDARY Change in Mean-Max Bifurcation CIMT	0.0033; 0.0072	—
SECONDARY Change in Mean-Mean Bifurcation CIMT	0.0030; 0.0055	—
SECONDARY Change in Mean-Max Far Wall CIMT	0.0045; 0.0082	—
SECONDARY Change in Mean-Mean Far Wall CIMT	0.0042; 0.0064	—
SECONDARY Change in Mean-Max Near Wall CIMT	0.0024; 0.0038	—
SECONDARY Change in Mean-Mean Near Wall CIMT	0.0022; 0.0028	—
SECONDARY Change in Natural Log of mg/L for hsCRP	-0.13; 0.27	—
SECONDARY Change in Total Cholesterol	-30.30; -0.72	—
SECONDARY Change in HDL Cholesterol	-0.43; 0.89	—
SECONDARY Change in LDL Cholesterol	-27.63; -1.48	—
SECONDARY Change in Triglycerides	-11.04; -5.62	—
SECONDARY Change in Lipoprotein A	2.00; 6.34	—
SECONDARY Change in Homocysteine	1.84; 1.76	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00065806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.