Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
Purpose
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
Eligibility
- Eligible Ages
- Between 5 Years and 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT04833465
- Status
- Recruiting
- Sponsor
- Children's National Research Institute