CIMAX (CIMzia in AXial spondyloarthritis).
Research type
Research Study
Full title
A NONINTERVENTIONAL STUDY TO ASSESS THE EFFECTIVENESS OF CERTOLIZUMAB PEGOL IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS IN DAILY PRACTICE
IRAS ID
162614
Contact name
Zoe Kingston-Griffiths
Contact email
Sponsor organisation
UCB Biosciences GmbH
Clinicaltrials.gov Identifier
MUSC 3731, NIHR CRN reference
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is a European multi-center, prospective non-interventional cohort study (NIS) in patients with axial spondyloarthritis (axSpA) who have been newly prescribed Cimzia® (certolizumab pegol). A total of 678 patients with axSpA, approximately 488 with AS and 190 with nr-axSpA, will be followed in this study. Patients will be followed for approximately 52 weeks. The choice of medical treatment with Cimzia® is made independently by the treating physician in the regular course of practice and is not influenced by the NIS observational plan. The decision to prescribe Cimzia® for a patient with axSpA is based on the physician’s individual clinical diagnosis, disease status, and treatment choice. The physician will not be asked to perform any additional examinations or investigations such as x-ray or MRI. The physician should follow the routine clinical practice for axSpA existing in his/her site/country.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0068
Date of REC Opinion
13 Mar 2015
REC opinion
Further Information Favourable Opinion