CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 736 enrolled
Drug / intervention
Certolizumab Pegol +1 morebiological
Likely dose
Certolizumab Pegol 200 mgfrom 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.

Search/NCT02505542
NCT02505542Phase 3Completed
CompareCT.gov

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

UCB BIOSCIENCES GmbH·interventional·Posted Jul 22, 2015·Updated Dec 17, 2020

In Brief

A Phase 3 clinical trial evaluating Certolizumab Pegol and Placebo for Axial Spondyloarthrithis and Ankylosing Spondylitis. Completed, enrolled 736 participants across 108 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAxial Spondyloarthrithis, Ankylosing Spondylitis
CountriesBelgium, Bulgaria, Czechia, France, Germany, Hungary, Netherlands, Poland, Romania, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 22, 2015
Enrollment StartJul 1, 2015
Primary CompletionFeb 1, 2019
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.9 years ago

Interventions

Certolizumab Pegolbiological

* Active substance: Certolizumab Pegol * Pharmaceutical form: Prefilled syringe * Concentration: 200 mg / ml * Route of Administration: Subcutaneous injection

Placeboother

* Active substance: Placebo * Pharmaceutical form: Prefilled syringe * Concentration: 0.9 % Saline * Route of Administration: Subcutaneous injection