NCT04833465 Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
| NCT ID | NCT04833465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Juvenile Idiopathic Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-07-16 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2021-07-16 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overarching goal of this study is the development of a physiologic endpoint of pain and treatment effect in three distinct rheumatology populations. This would enable objective assessment of pain and treatment in these populations and enable a much more precise approach to treatment. Such an endpoint stands to significantly improve outcomes in these patients by eliminating the need for a trial-and-error approach to treatment. This is a single site observational study that aims to collect initial pilot data in three distinct patient groups. As this is observational, there is no randomization or blinding in the study. Patients will be followed for a period of one year after enrollment. Baseline measurements will be taken at the time of enrollment, and at each subsequent standard of care clinic visit as feasible, for a period of one year. As this is an observational study, there will be no change to the treatment for any patient due to research activities. The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations. The secondary objective is the characterization of the nociceptive index in these populations in response to standard of care interventions. This is necessary to demonstrate the ability of this approach to serve as an endpoint of treatment effect.
Eligibility Criteria
Inclusion Criteria: In order to be eligible for inclusion in the study, an individual must meet all of the following criteria: * Male or female ≥ 5 years of age at screening. * Documentation of a JIA, SLE or FM diagnosis as evidenced by history Exclusion Criteria: Any individual who meets any of the following criteria will be excluded from participation in this study: • Documented history of eye disease precluding pupillometry
Frequently Asked Questions
Who can join the NCT04833465 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 21 Years, studying Juvenile Idiopathic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04833465 currently recruiting?
Yes, NCT04833465 is actively recruiting participants. Visit ClinicalTrials.gov or contact Children's National Research Institute to inquire about joining.
Where is the NCT04833465 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT04833465 clinical trial?
NCT04833465 is sponsored by Children's National Research Institute. The trial plans to enroll 90 participants.