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NCT Number: NCT04833465

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.

Recruiting

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Key information

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location status: Recruiting

Location contact

Julia C Finkel, MD

CONTACT

[email protected]

(202)476-4867

Julia C Finkel, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. Index Characterization

    Time frame: 1 Year

    The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations.

Secondary outcomes

  1. Treatment Effect

    Time frame: 1 Year

    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.

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Apr 6, 2021
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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