Developing a way to measure treatment effects in children with rheumatologic conditions
Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
This study is trying to find a better way to measure how well treatments work for kids with certain rheumatologic conditions like Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, and Fibromyalgia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT04833465 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a physiologic endpoint for assessing pain and treatment effects in children with Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, and Fibromyalgia. By collecting pilot data over one year, the study will follow patients during their standard care visits without altering their treatment. The goal is to establish a more objective method for evaluating treatment outcomes, potentially reducing the trial-and-error approach currently used. The study will include children aged 5 and older who have a documented diagnosis of one of the target conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 and older diagnosed with Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, or Fibromyalgia.
Not a fit: Patients with documented eye diseases that prevent pupillometry will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more precise and effective treatment strategies for children with rheumatologic conditions.
How similar studies have performed: While similar studies have explored endpoints in rheumatologic conditions, this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia
- Children's National Health System — Washington D.C., District of Columbia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.