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NCT04833465 · ClinicalTrials.gov registry record
Development of a Therapeutic Endpoint in Pediatric Rheumatologic Conditions
A clinical trial of Systemic Lupus Erythematosus and Fibromyalgia, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- 90
- Enrollment target
- 1
- Study location
NCT04833465: Recruiting study of Systemic Lupus Erythematosus and Fibromyalgia, sponsored by Children's National Research Institute.
NCT04833465 is a study of Systemic Lupus Erythematosus and Fibromyalgia that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 90 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04833465, a study of Systemic Lupus Erythematosus and Fibromyalgia, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- 90 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary objective of this study is the characterization of the nociceptive index in three pediatric rheumatology populations.
Conditions Studied
Interventions
- OTHER No Intervention
Study Locations (1)
District of Columbia
- Children's National Health System - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-07-16 |
| Est. Completion | 2025-12-01 |
What NCT04833465 shows while recruiting
NCT04833465 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (76% lower).
The record links to 3 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which No Intervention is the first listed.
NCT04833465 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04833465 about?
NCT04833465 is a clinical study titled "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 end...
What is the current status of trial NCT04833465?
This trial is currently recruiting. The enrollment target is 90 participants. The study started on 2021-07-16. Estimated completion is 2025-12-01.
What conditions does trial NCT04833465 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Fibromyalgia, Juvenile Idiopathic Arthritis.
What interventions are being tested in trial NCT04833465?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT04833465?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04833465 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04833465's enrollment target sits among peer trials
90 58th of 99 higher than 42 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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