Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
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
🗓️ Study Start (Actual) 16 July 2021
🗓️ Primary Completion (Estimated) 1 September 2024
✅ Study Completion (Estimated) 1 December 2024
👥 Enrollment (Estimated) 90
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 5 Years to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 April 2021
  • First Submitted that Met QC Criteria 2 April 2021
  • First Posted 6 April 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 July 2024
  • Last Update Posted 5 July 2024
  • Last Verified July 2024