Actively Recruiting

Age: 5Years - 21Years
All Genders
NCT04833465

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Led by Children's National Research Institute · Updated on 2026-04-06

90

Participants Needed

1

Research Sites

297 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Who Can Participate

Age: 5Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 65 years of age at screening
  • Documentation of a diagnosis of juvenile idiopathic arthritis, systemic lupus erythematosus, or fibromyalgia
Not Eligible

You will not qualify if you...

  • Documented history of eye disease that would prevent pupillometry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's National Health System

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions | DecenTrialz