Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 5 Years to 21 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at a body-based measure of pain to learn how well it tracks pain and treatment effects in children with certain rheumatic conditions. These conditions can affect joints or other parts of the body, or cause widespread pain. The study follows patients for one year without changing their usual treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 5 or older at screening.
- A medical history showing juvenile idiopathic arthritis (JIA, a type of childhood joint disease), systemic lupus erythematosus (SLE, or lupus), or fibromyalgia (FM, a condition that causes widespread pain).
Who can't join
- A recorded history of eye disease that prevents pupillometry, a test that measures the eye’s pupil.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
DC
- Children's National Health System · Washington D.C., DC 20010Julia C Finkel, MD · Study contact · (202)476-4867 · jfinkel@cnmc.orgJulia C Finkel, MD · Principal investigatorMore trials in Washington D.C.