Clinical Trial

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

Study acronym: BACK-OFF JSpA
Completed Phase 4
View on ClinicalTrials.gov →
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 31 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.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-06
critical Phase changed: not applicable -> Phase 4 2026-08-06
notable Primary completion moved earlier: 2026-07-01 -> 2026-06-01 2026-08-06
minor Completion moved earlier: 2026-07-01 -> 2026-06-01 2026-08-06
Trial Details
NCT Number NCT04891640
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Juvenile Spondyloarthritis
Enrollment 164 participants
Start Date 2021-11-11
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-05