Biologics for Children with Rheumatic Diseases (BCRD)
Short title: Safety and effectiveness of biologic treatments in children
Full title of the research: The Long – term Safety and Efficacy of Biologic Therapies in Children with Rheumatic Diseases
REC Reference Number: 09/H1008/137
CSP reference: 24269
UK CRN ID: 7725 – ‘The Extended Biologics Study’
The Biologics for Children with Rheumatic Diseases (BCRD) study is a prospective observational cohort study which aims to recruit all children with Juvenile Idiopathic Arthritis who are starting therapy with a biologic drug other than etanercept. A parallel cohort of children starting Methotrexate will also be collected. Recruitment and data collection will be facilitated by research nurses established in a number of key paediatric centres across the UK and in particular through collaboration with the MCRN/CLRN and its Local Research Networks (LRN). All children will be followed for a minimum of 5 years. The response to treatment will be assessed at regular intervals using the American College of Rheumatology (ACR) JIA core outcome variables, including active and joint counts, inflammatory markers, pain and disability levels. The rates of serious adverse events, defined as events resulting in death, hospitalisation, disability, or are otherwise life-threatening, will be compared with those observed in a cohort of patients receiving Methotrexate.
The study aims to recruit all children with JIA who are being newly treated with biologic agents (other than etanercept) in the UK and has a proposed sample size of 250 children. There is also a proposed sample size of 250 children for the Methotrexate cohort.
Contact
If you would like any additional information regarding the study, please contact Katy Evans (Study Coordinator)
Katy.evans@manchester.ac.uk
Tel: 0161 3061917
Fax: 0161 2751640
BCRD
Arthritis Research UK Epidemiology Unit
The University of Manchester
Rutherford House (Unit 4)
Manchester Science Park
40 Pencroft Way
MANCHESTER
M15 6SZ
