Recruiting

Observational Study

Sponsor:

Children's National Research Institute

Code:

NCT04833465

Conditions

Juvenile Idiopathic Arthritis

Systemic Lupus Erythematosus

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

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.

Conditions

Juvenile Idiopathic Arthritis

Systemic Lupus Erythematosus

Fibromyalgia

Study ID

NCT04833465

Start date

Jul 16, 2021

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

JIA

Patients ages 5-21 with a diagnosis of JIA.

SLE

Patients ages 5-21 with a diagnosis of SLE.

FM

Patients ages 5-21 with a diagnosis of FM.

Interventions

No Intervention

No Intervention

Primary outcome measure

  • Index Characterization [ Time Frame: 1 Year ]

Central Contacts and Locations

Locations

Children's National Health System

Recruiting

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

Contacts

Principal Investigator:

Julia C Finkel, MD

More Information

Sponsor

Children's National Research Institute

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2026-07-24.