drugset / Trial / NCT03020992

A Study to Assess the Effects of Certolizumab Pegol on the Reduction of Anterior Uveitis (AU) Flares in Axial Spondyloarthritis Subjects With a Documented History of AU

NCT03020992 ↗

Phase 4 Completed 89 enrolled UCB Biopharma SRL
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active axial Spondyloarthritis (axSpA) and a documented history of AU.

Timeline

Start
2016-12-21
Primary completion
2019-12-04
Completion
2020-01-23

Outcome

Met primary endpoint

paper There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline PMID 33854572 ↗

registry analysis (other test); Certolizumab Pegol (FAS); p <0.001; Rate ratio 0.180 (95% CI 0.116 to 0.281); Poisson regression NCT03020992 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Certolizumab Pegol Protein / enzyme biologic 200 mg Subcutaneous