Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

NCT04833465 | Recruiting

• 1 other identifier: Pro00015629
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Index Characterization

  The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations.

  1 Year

Secondary Outcomes (1)

• Treatment Effect

  1 Year

Study Arms (3)

JIA

Patients ages 5-21 with a diagnosis of JIA.

Other: No Intervention

SLE

Patients ages 5-21 with a diagnosis of SLE.

Other: No Intervention

FM

Patients ages 5-21 with a diagnosis of FM.

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

FM; JIA; SLE

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

30 subjects from each of the three populations of interest will be enrolled for this study.

You may qualify if:

• Male or female ≥ 5 years of age at screening.
• Documentation of a JIA, SLE or FM diagnosis as evidenced by history

You may not qualify if:

• Any individual who meets any of the following criteria will be excluded from participation in this study:
• Documented history of eye disease precluding pupillometry

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Health System

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

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile; Lupus Erythematosus, Systemic; Fibromyalgia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Pediatrics

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 6, 2021
• Study Start: July 16, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)