NCT04891640

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

Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This project is a prospective, 12-month pragmatic randomized trial embedded within routine clinical care. Children with spondyloarthritis who have maintained inactive disease on a clinically prescribed standard dosing of a TNFi for 6 months or longer will be eligible for enrollment. Children will be randomized to one of the following alternative approaches: continued fixed standard dosing (arm 1), fixed longer dosing intervals of TNFi (arm 2), or stopping TNFi (arm 3). The recommended visit frequency is every 3 months through the study endpoint at 12 months. After subjects have followed their treatment assignment for 12 months, those who have not flared may modify their treatment regimen as per shared decision making between themselves and the treating physician. All participants will be monitored for 24 additional months for long-term outcomes after the intervention period.

Conditions

• Juvenile Spondyloarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-11
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2021-05-18
• Last updated: 2025-08-05

Locations

31 sites across 2 countries: United States, Canada