Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
Completed · Phase 3 · Has a placebo group
Conditions studied: Lupus Erythematosus, Systemic
In brief
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).
Key facts
- Study ID
- NCT00065806
- Run by
- Laura Schanberg
- People needed
- 221
- Starts
- 2003-09-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2013-08-15
Who can join
Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Duke Medical Center / Duke Clinical Research Institute — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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