drugset / Trial / NCT01934933

Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis

NCT01934933

Phase 4 Completed 150 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS). Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib 200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.

Timeline

Start
2014-09-24
Primary completion
2015-09-23
Completion
2017-01-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 200 mg
Comparator Etanercept Protein / enzyme biologic 25 mg Subcutaneous