NCT02505542

Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 736 (actual)
• Sponsor: UCB BIOSCIENCES GmbH · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.

Conditions

• Axial Spondyloarthrithis
• Ankylosing Spondylitis

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: 2015-07-01
• Primary completion: 2019-02-01
• Completion: 2019-04-01
• First posted: 2015-07-22
• Last updated: 2020-12-17
• Results posted: 2020-04-21

Locations

108 sites across 14 countries: United States, Belgium, Bulgaria, Czechia, France, Germany, Hungary, Netherlands, Poland, Romania, Spain, Taiwan, Turkey (Türkiye), United Kingdom