The BSPAR Biologics and New Drugs Registry. » What are the aims of the BSPAR Biologics and New Drugs Register? » How is the Registry Organised? » Why does BSPAR want to collect information on new drugs? » What information is collected? Contact the Registry What are the aims of the BSPAR Biologics and New Drugs Register? The aims of the Register are: 1. To collect information on children and young people prescribed biological therapies and other new drugs for Juvenile Idiopathic Arthritis (JIA), including information about the patients' characteristics, disease type and activity, outcomes and drug safety. 2. To collect data on children and young people with JIA who are prescribed methotrexate. 3. To as far as possible to collect information on patients treated with other new drugs for JIA when such drugs become available. ^ Top How is the Register organised? BSPAR provides a Management Committee and a Data Integrity Committee and the Register is hosted by Birmingham University. ^ Top Why does BSPAR want to collect information on new drugs? Etanercept, an anti- Tumour Necrosis Factor (TNF) and the first biologic agent licensed for the treatment of JIA, has been shown to improve disease (at least in the short term) on disease adults with rheumatoid arthritis and children with Juvenile Idiopathic Arthritis (JIA). The drug was tested in children in whom treatment with methotrexate had failed in one randomised control trial study. No evidence is as yet available on whether etanercept has an effect on structural joint damage in children but evidence is emerging that structural joint damage is reduced in adults with rheumatoid arthritis who have received etanercept. Methotrexate is now an established treatment for relatively severe and longstanding JIA, but there is limited evidence on its long term impact. Other biologic agents and new drugs are likely to be introduced into clinical practice in the near future. A well designed register-based cohort study will allow some evidence on long term outcomes, particularly on how safe the drugs are, although this kind of study does not provide the best evidence on which drugs work best. NICE Guidance on prescribing etanercept strongly recommended that all clinicians prescribing etanercept for children and young people with JIA should (with the permission of the child and/or parent) register the child with the Biologics Registry. ^ Top What information is collected? The British Society for Paediatric and Adolescent Rheumatology (BSPAR) Biologics and New Drugs Register (BNDR) will prospectively collect standardised information on: 1. Children and young people who are prescribed biologics and other new drugs. 2. Children and young people prescribed methotrexate (who will act as a control group). Data to be collected at base-line and follow-up (at three months, six months, twelve months and subsequently yearly) includes: Age, gender, presentation and duration of disease, diagnosis and prior treatments. Prior history of TB and immunisation status. The Core Outcome Variables for JIA. Full blood count, autoantibodies, electrolyte and liver enzyme profile. Height and weight. School absence. Co-morbidity and relevant history. Current therapy and month of and reasons for any discontinuation of therapy and any recommencement of therapy. Adverse events. Hospitalisations. Ophthalmological, radiological, surgical data. ^ Top Please note that BSPAR does not make any guarantee as to the validity of the information contained in any of the linked internet sites. British Society of Paediatric & Adolescent Rheumatology Site developed and maintained by Dataphiles Ltd © Dataphiles Ltd. 2005 BSPAR is a Charitable Company registered in England and Wales. Company number 06978211. Registered Charity # 1132967 Registered office: Department of Rheumatology, Alder Hey Children’s NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP