MedTrace Logo

Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis

NCT04891640 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-08-05

No results posted yet for this 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.

Conditions

  • Juvenile Spondyloarthritis

Interventions

OTHER

Standard TNFi Therapy

Participants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed.

OTHER

TNFi fixed longer dosing intervals

Participants randomly assigned to this arm will increase the time between TNFi medication doses. * Adalimumab- from every 2 to 3 weeks * Certolizumab- from every 2 to 4 weeks * Etanercept- from every 1 to 2 weeks * Golimumab- from every 4 to 6 weeks * Infliximab- from baseline to baseline + 2 weeks

OTHER

Stop TNFi treatment

Participants randomly assigned to this arm will stop TNFi medication.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891640 on ClinicalTrials.gov