Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

NCT ID: NCT04833465

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-16
• Study Completion Date: 2025-12-01

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

JIA

Patients ages 5-21 with a diagnosis of JIA.

No Intervention

Intervention Type: OTHER

No Intervention

SLE

Patients ages 5-21 with a diagnosis of SLE.

No Intervention

Intervention Type: OTHER

No Intervention

FM

Patients ages 5-21 with a diagnosis of FM.

No Intervention

Intervention Type: OTHER

No Intervention

Interventions

No Intervention

No Intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Julia Finkel

Professor of Anesthesiology and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's National Health System

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

Site Status: RECRUITING

Countries

United States

Facility Contacts

Julia C Finkel, MD

Role: primary

jfinkel@cnmc.org

202-476-4867

Other Identifiers

Pro00015629

Identifier Type: -

Identifier Source: org_study_id