ClinicalTrials.gg
RecruitingNCT04833465Updated Jul 24, 2026

Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions

An observational study in Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus and Fibromyalgia, sponsored by Children's National Research Institute. Recruiting at 1 site in United States. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Children's National Research Institute · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 3 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
5 Years to 21 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 109 studies in Arthritis, Juvenile with a site in United States — 20 open to participants now, 23 under way, 5 of them phase 3. Arthritis, Juvenile · United States.

Planned enrollment
21st of 24
90 · median 288
Started
2021
with 2 others
Observational
24 of 109
10 open now
Primary completion
2028-04
later than 6 of 21 live
Registered
86th of 109
by date

Among the 109 studies in Arthritis, Juvenile with a site in United States, this one is the 21st largest by planned enrollment of the 24 observational ones that give a count, is one of 3 that started in 2021, is one of 24 observational ones, reaches primary completion later than 6 of the 21 other live ones, and was the 86th registered.

Arthritis, Juvenile

365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.

Browse Arthritis, Juvenile studies →

Open to participants now

20 of the 109 studies in Arthritis, Juvenile with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 69 Arthritis, Juvenile studies recruiting now, 13 (19%) set no upper age limit and 50 (72%) stop at 75 or younger; 65 take children under 18; 11 take healthy volunteers.

This study: 5 Years to 21 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • Juvenile Idiopathic Arthritis
  • Systemic Lupus Erythematosus
  • Fibromyalgia
04

Who can participate

Ages eligible
5 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

30 subjects from each of the three populations of interest will be enrolled for this study.

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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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • JIA

    Patients ages 5-21 with a diagnosis of JIA.

    Other: No Intervention

  • SLE

    Patients ages 5-21 with a diagnosis of SLE.

    Other: No Intervention

  • FM

    Patients ages 5-21 with a diagnosis of FM.

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No Intervention

06

What researchers measure

Primary outcomes

  1. Index Characterization

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

    Time frame: 1 Year

Secondary outcomes

  1. Treatment Effect

    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.

    Time frame: 1 Year

07

Study locations

1 of 1 sites recruiting
  • Children's National Health System
    Washington D.C., District of Columbia 20010, United States
    Recruiting
    • Julia C Finkel, MD · Contactjfinkel@cnmc.org · (202)476-4867
    • Julia C Finkel, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Apr 2028, 81 months after the start.

Of 42 observational studies under Arthritis, Juvenile, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 186. This study's planned 81 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2021
First posted
Apr 6, 2021
StartActual
Jul 16, 2021
Primary completionEst.
Apr 2028
CompletionEst.
Dec 2028
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04833465
Responsible party
Julia Finkel (Professor of Anesthesiology and Pediatrics, Children's National Research Institute) — Principal investigator
First posted
Apr 6, 2021
Start date
Jul 16, 2021
Primary completion
Apr 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 24, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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