NCT02552212

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Axial Spondyloarthritis
• Nonradiographic Axial Spondyloarthritis
• Nr-axSpA

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab Pegol	* Active Substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringe * Concentration: 200 mg / ml * Route of Administration: Subcutaneous injection
OTHER	Placebo	* Active Substance: Placebo * Pharmaceutical Form: Prefilled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous injection

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-05-01
• Completion: 2020-05-01
• First posted: 2015-09-17
• Last updated: 2022-08-18
• Results posted: 2020-08-17

Locations

105 sites across 9 countries: United States, Australia, Bulgaria, Canada, Czechia, Hungary, Poland, Russia, Taiwan