C-Optimise
Research type
Research Study
Full title
Multicentre, Open-Label (Part A) Followed By A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study (PART B) To Evaluate Maintenance Of Remission In Subjects With Active Axial Spondyloarthrits (AXSPA) Receiving Either Certolizumab Pegol 200MG Q2W Or 200MG Q4W As Compared To Placebo
IRAS ID
181518
Contact name
Minal Kara
Contact email
Sponsor organisation
UCB BIOSCIENCES GmbH
Eudract number
2015-000339-34
Duration of Study in the UK
3 years, 1 months, 15 days
Research summary
Axial Spondyloarthritis (axSpA) is a chronic inflammatory disease that affects 0.5% proportion of the adult population. The majority of patients with axSpA have inflammatory back pain. The most characteristic feature of axSpA is the formation of new bone that may ultimately lead to a fusion of the spine. The disease typically originates in the sacroiliac joints (where your lower back meets with the pelvis), then progresses to the spine.
Disability in axSpA is related to both the degree of inflammatory activity, causing pain, stiffness, fatigue, and poor quality of sleep, and to the degree of new bone formation, causing structural changes of the spine. Axial SpA typically begins in patients < 45 years of age. Unfortunately, many patients are diagnosed in a late stage of this disease when fusion of the sacroiliac joints and maybe even the spine has already progressed significantly.
In this study participants with an early disease stage, showing evidence of inflammation on MRI or elevated inflammation parameters (non radiographic axSpA) or progressed stage disease (AS – Ankylosing Spondylitis) will be treated with an anti-inflammatory biological drug named Certolizumab pegol.
The aim of this study is to examine whether treatment with Certolizumab pegol results in a significant improvement of the health status of patients and to demonstrate that the improved health status can be maintained after reduction or even withdrawal of the study drug.
This is a randomised, placebo-controlled, double−blind study meaning neither the patient nor the study doctor will know which medication is being given.
UCB Biosciences is the sponsor of this multicentre study which will take place across Europe, North America and Asia. It is anticipated that approximately 750 participants will be recruited worldwide.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0260
Date of REC Opinion
24 Oct 2015
REC opinion
Further Information Favourable Opinion