Juvenile Idiopathic ArthritisNCT04833465
Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
An observational study of Juvenile Idiopathic Arthritis and Systemic Lupus Erythematosus, run by Children's National Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, Fibromyalgia
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 30 subjects from each of the three populations of interest will be enrolled for this study.
Who may be able to join
- 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
Who cannot join
- Any individual who meets any of the following criteria will be excluded from participation in this study:
- Documented history of eye disease precluding pupillometry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Health System
Washington D.C., District of Columbia, 20010
Julia C Finkel, MD, (202)476-4867, jfinkel@cnmc.org
Julia C Finkel, MD
About this study
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.
- Being tested
- No Intervention
- Medical subject headings
- Arthritis, Juvenile, Lupus Erythematosus, Systemic, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| JIA | Patients ages 5-21 with a diagnosis of JIA. Receives: Other: No Intervention | |
| SLE | Patients ages 5-21 with a diagnosis of SLE. Receives: Other: No Intervention | |
| FM | Patients ages 5-21 with a diagnosis of FM. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index Characterization
The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations.
Measured: 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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start16 Jul 2021
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Finkel, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833465
- Sponsor's protocol ID
- Pro00015629
- Status last verified
- Jul 2026
- First submitted
- 2 Apr 2021
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
- ClinicalTrials.gov ID
- NCT04833465
- Acronym / sponsor ID
- Pro00015629
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JIA | – | Other: No InterventionPatients ages 5-21 with a diagnosis of JIA. |
| SLE | – | Other: No InterventionPatients ages 5-21 with a diagnosis of SLE. |
| FM | – | Other: No InterventionPatients ages 5-21 with a diagnosis of FM. |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 30 subjects from each of the three populations of interest will be enrolled for this study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Any individual who meets any of the following criteria will be excluded from participation in this study:
- Documented history of eye disease precluding pupillometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | FM, JIA, SLE |
Primary outcome
Index Characterization
Time frame: 1 Year
The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations.
1 secondary outcome
Treatment Effect
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis and Systemic Lupus Erythematosus, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index Characterization (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.