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
Abstract
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.
Conditions: Axial Spondyloarthritis, Nonradiographic Axial Spondyloarthritis, Nr-axSpA.
Primary outcome: Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52; Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12; Certolizumab Pegol Plasma Concentration at Baseline; Certolizumab Pegol Plasma Concentration at Week 1; Certolizumab Pegol Plasma Concentration at Week 2; Certolizumab Pegol Plasma Concentration at Week 4; Certolizumab Pegol Plasma Concentration at Week 12; Certolizumab Pegol Plasma Concentration at Week 24; Certolizumab Pegol Plasma Concentration at Week 36; Certolizumab Pegol Plasma Concentration at Week 52; Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit.
Enrollment: 317 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 317 participants or records.
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