drugset / Trial / NCT02407223

An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis

NCT02407223 ↗

Phase 3 Terminated 356 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

Timeline

Start
2015-07-13
Primary completion
2017-09-26
Completion
2017-09-26

Outcome

Outcome not reported

Stopped: “This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ustekinumab Monoclonal antibody 45 mg Subcutaneous
Subject Ustekinumab Monoclonal antibody 90 mg Subcutaneous