drugset / Trial / NCT01934933
Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Celecoxib | Other / unclassified | 200 mg | — |
| Comparator | Etanercept | Protein / enzyme biologic | 25 mg | Subcutaneous |