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 range

10 Years – 21 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Lupus Erythematosus, Systemic trials