NCT04833465Recruiting
Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 2 Apr 2021
- Start date
- 16 Jul 2021
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Children's National Research Institute
- Diseases
- Lupus (SLE)
- NCT number
- NCT04833465
What you commit to
- Study type: Observational
- Planned participants: 90
- From 16 Jul 2021 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Documented history of eye disease precluding pupillometry
Other
- Any individual who meets any of the following criteria will be excluded from participation in this study:
Who the study is looking for
- 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
Age in the registry: 5 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Health System Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.