Individual Patient Exposure and Response in Pediatric Lupus

This is an exploratory Phase 2, single site, open-label, direct-to-family, adherence and exposure-response study of hydroxychloroquine (HCQ) in pediatric systemic lupus. The study will measure a participant's adherence to HCQ self-administration using an electronic pill bottle cap that records date/time of bottle opening and provides participants with a reminder when a dosage is due and/or missed. All participants will be provided with the electronic pill bottle cap to use with their regular HCQ prescription at the start of the study. For the first 2 weeks of the trial, the electronic notifications will be disabled to determine a baseline measure of adherence. Within 1 day after Visit 2, the electronic notifications will be turned on for all participants, resulting in a series of alerts (via electronic pill bottle cap alerts and smartphone push notifications, text message, and/or automated phone calls). Participants will continue to receive notifications via the electronic pill bottle cap through Visit 4. Throughout the study, participants will undergo a series of blood draws and urinalysis collections, and be asked to complete various questionnaires.

Inclusion criteria

• Signed and dated informed consent form and assent, when necessary
• Age 5-17.5 years at consent
• Enrolled in the CARRA Registry with a diagnosis of systemic lupus erythematosus as documented in the CARRA Registry
• Receiving hydroxychloroquine as standard of care for ≥ 3 months
• Participant and Caregiver primary language of English
• Willing and able to comply with study procedures, at the discretion of the study principal investigator
• Access to internet

Exclusion criteria

There are no pre-defined exclusion criterion for this trial.