At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 325 enrolled
Drug / intervention
CZP 200 mg Q2W +2 morebiological
Likely dose
CZP 200 mg Q2Wfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
In Brief
A Phase 3 clinical trial evaluating CZP 200 mg Q2W, CZP 400 mg Q4W, and 1 other intervention for Spondyloarthropathies. Completed, enrolled 325 participants across 104 sites in 15 countries.
Detailed Summary
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpondyloarthropathies
CountriesArgentina, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionOct 2011
Study CompletionAug 2015
TodayJul 2026
First PostedMar 16, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2011
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.3 years ago
Interventions
CZP 200 mg Q2Wbiological
200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
CZP 400 mg Q4Wbiological
400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
Placeboother
Matching Placebo to CZP injection.