- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04358302
Individual Patient Exposure and Response in Pediatric Lupus (iPERSONAL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27701
- Duke Clinical Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Device use
All participants will be provided with the electronic pill bottle cap called "Pillsy" to use with their regular HCQ prescription bottles at the start of the study.
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The electronic pill bottle cap, Pillsy, and its accompanying software application provides reminders to take a scheduled dosage of medication via bottle cap alerts and smartphone push notifications, text messages, and/or automated phone calls. The Pillsy application records dosing dispense date and time when the user opens the bottle. During 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). The electronic pill bottle cap, Pillsy, is a commercially available device marketed to consumers. The electronic pill bottle cap does not capture or store PHI. Quick tips on how to use Pillsy can be found at https://www.pillsy.com/instructions |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in proportion of dispensed doses from the first two weeks (baseline) to last two weeks of study (device use)
Time Frame: Days 1-14 compared to days 166-180 (+/- 30)
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The Pillsy device will record the number of dispensed doses
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Days 1-14 compared to days 166-180 (+/- 30)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to hydroxychloroquine using the Medication Adherence Self-Reported Inventory (MASRI) score
Time Frame: Up to 6 months
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The MASRI is a concise, self-administered survey completed by the patient at study visits.
The MASRI is a patient-reported numeric estimate of medication adherence rate (0-100%) with non-adherence defined as MASRI <80% and adherence defined as >/=80%.
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Up to 6 months
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Adherence to hydroxychloroquine using serum drug levels
Time Frame: Up to 6 months
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Serum drug levels will be measured by patient blood collection at study visits
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Up to 6 months
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Adherence to hydroxychloroquine using electronic pill counts
Time Frame: Up to 6 months
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Electronic pill counts will be obtained by the Pillsy device
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Up to 6 months
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Adherence to hydroxychloroquine using manual pill counts
Time Frame: Up to 6 months
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Manual pill counts will be conducted by the nurse at study visits
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Up to 6 months
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Disease activity as measured by Systemic Lupus Activity Questionnaire (SLAQ) score
Time Frame: Up to 6 months
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The SLAQ is a concise, self-administered survey completed by the patient at study visits.
The SLAQ measures patient-reported disease activity and scores range from 0-44, with 0 representing no disease activity and 44 representing maximum disease activity.
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Up to 6 months
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Disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score collected through a remote teleresearch exam
Time Frame: Up to 2 months
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A physician will conduct a remote SLEDAI-2K assessment of the patient at study visit 1.
The SLEDAI-2K measures physician-reported disease activity and scores range from 0-105, with 0 representing no disease activity and 105 representing maximum disease activity.
A score of >/=6 represents clinically important disease activity and a reduction of at least 4 represents clinically meaningful improvement in disease activity.
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Up to 2 months
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Disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score recorded in the CARRA Registry
Time Frame: Up to 6 months
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SLEDAI-2K score recorded from the patient's closest CARRA Registry visit relative to visit 1
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Up to 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen J Balevic, MD, MHS, Duke Clinical Research Institute
Publications and helpful links
General Publications
- Balevic SJ, Randell R, Weiner D, Beard C, Schanberg LE, Hornik CP, Cohen-Wolkowiez M, Gonzalez D; with the CARRA Registry investigators. Pharmacokinetics of hydroxychloroquine in paediatric lupus: data from a novel, direct-to-family clinical trial. Lupus Sci Med. 2022 Nov;9(1):e000811. doi: 10.1136/lupus-2022-000811.
- Randell RL, Singler L, Cunningham A, Schanberg LE, Cohen-Wolkowiez M, Hornik CP, Balevic SJ; with the CARRA Registry investigators. Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial. Lupus Sci Med. 2021 May;8(1):e000494. doi: 10.1136/lupus-2021-000494.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00104621
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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