drugset / Trial / NCT03841357

Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)

NCT03841357 ↗

Phase 3 Completed 121 enrolled Duke University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a research study to test whether a once-weekly injection of abatacept will prevent the progression of Juvenile Idiopathic Arthritis (JIA) to a more severe form. To evaluate the effectiveness of a 24-week course of treatment with abatacept plus usual care versus usual care to prevent polyarthritis (≥5 joints), uveitis, or treatment with other systemic medication within 18 months of randomization in children with recent-onset limited JIA.

Timeline

Start
2019-10-29
Primary completion
2025-01-22
Completion
2025-01-22

Outcome

Missed primary endpoint

registry analysis (superiority test); Abatacept and Usual Care (Part I) vs Active Comparator: Usual Care (Part I); p = 0.7357; Relative Risk 0.929 (95% CI 0.603 to 1.429) NCT03841357 ↗

registry analysis (superiority test); Abatacept and Usual Care (Part I) vs Active Comparator: Usual Care (Part I); p = 0.507; Relative Risk 1.333 (95% CI 0.565 to 3.145) NCT03841357 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified — Subcutaneous