At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation
In Brief
A Phase 3 clinical trial evaluating Certolizumab Pegol and Placebo for Axial Spondyloarthritis and 2 related conditions. Completed, enrolled 317 participants across 105 sites in 9 countries.
Detailed Summary
Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.
Study Details
Timeline
Interventions
* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringe * Concentration: 200 mg / ml * Route of Administration: Subcutaneous injection
* Active Substance: Placebo * Pharmaceutical Form: Prefilled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous injection