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NCT04891640 · ClinicalTrials.gov registry record · NA
Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis
A NA study of Juvenile Spondyloarthritis, sponsored by Children's Hospital of Philadelphia.
- Active
- Registry status
- NA
- Development phase
- 164
- Enrollment target
- 20
- Study locations
NCT04891640: Active NA study of Juvenile Spondyloarthritis, sponsored by Children's Hospital of Philadelphia.
NCT04891640 is a NA study of Juvenile Spondyloarthritis that is active but no longer recruiting, run by Children's Hospital of Philadelphia. The registered enrollment target is 164 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04891640, a NA study of Juvenile Spondyloarthritis, is active but no longer recruiting, sponsored by Children's Hospital of Philadelphia.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 164 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 29 participating pediatric healthcare systems. This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare (Aim 1) and patients' lived experiences (Aim 2) across three arms.
Primary Outcome
JSpA flare is defined as clinically meaningful worsening in ≥3 of the following: caregiver/patient assessment of well-being, physician assessment of disease activity, caregiver/patient assessment of pain, physical function, and active joint count. Meaningful change for well-being, disease activity, and pain are an increase of ≥2 on visual analogue scale (range 0-10 with higher scores indicating poorer well-being, higher disease activity, and higher magnitude of pain). Meaningful change in functi
Conditions Studied
Interventions
- OTHER Standard TNFi Therapy
- OTHER TNFi fixed longer dosing intervals
- OTHER Stop TNFi treatment
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Stanford University - Palo Alto
Missouri
- Children's Mercy Hospital - Kansas City
- St. Louis Children's Hospital - St Louis
New York
- Hospital for Special Surgery - New York
- Cohen Children's Medical Center - Queens
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Phoenix Children's - Phoenix
Colorado
- Children's Hospital of Colorado - Aurora
Delaware
- Nemours Children's Hospital - Wilmington
District of Columbia
- Children's National Health System - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2021-11-11 |
| Est. Completion | 2026-07-01 |
| Phase | NA |
What the registry record for NCT04891640 still lists
NCT04891640 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Juvenile Spondyloarthritis appearing as the primary indexed condition, and to 3 interventions - of which Standard TNFi Therapy is the first listed.
NCT04891640 names 20 study sites across 17 states, led by California, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT04891640 about?
NCT04891640 is a clinical study titled "Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis". This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 29 participating pediatric healthcare systems. This op...
What is the current status of trial NCT04891640?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 164 participants. The study started on 2021-11-11. Estimated completion is 2026-07-01.
What conditions does trial NCT04891640 study?
This clinical trial studies the following conditions: Juvenile Spondyloarthritis.
What interventions are being tested in trial NCT04891640?
The interventions under investigation include: Standard TNFi Therapy (OTHER), TNFi fixed longer dosing intervals (OTHER), Stop TNFi treatment (OTHER).
Who is sponsoring clinical trial NCT04891640?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04891640 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04891640's enrollment target sits among peer trials
164 626th of 2000 higher than 1,374 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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