Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 21
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Washington, D.c.
Children's National Health System
RECRUITING
Washington D.c.
Time Frame
Start Date: 2021-07-16
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 90
Treatments
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.
Sponsors
Leads: Children's National Research Institute

This content was sourced from clinicaltrials.gov