The CSG has been awarded a grant to support an Extended Biologics Study and a key priority area has been a trial of anti-TNF therapy in JIA-Uveitis.
Biologics for Children with Rheumatic Diseases – The Extended Biologics Study
The CSG’s JIA Topic Specific Group have been successful in being awarded a grant from Arthritis Research UK to support long term pharmacovigilance and efficacy data collection on children receiving biologics other than etanercept for rheumatic diseases. This Extended Biologics Study, which will run from the University of Manchester in parallel with the BSPAR Etanercept Cohort Study. Adopted onto the UK CRN and NIHR CRN: Children Portfolios, recruitment has already begun in June 2010.
Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab for the Treatment of Juvenile Idiopathic Arthritis-associated Uveitis
Following a comprehensive consultation process, a trial of anti-TNF therapy in JIA-Uveitis was set as a key priority area for the UK NIHR CRN: Children/Arthritis Research UK Paediatric Rheumatology Clinical Studies Group’s (CSG) Clinical Research Strategy. Widespread discussions took place, meetings open to representatives of participating centres, and discussion at specialty meetings and symposia where the potential trial was highlighted. A team including representatives from rheumatology, ophthalmology, parents, health economist and clinical trials unit (CTU) submitted a preliminary application last summer. Final submission was made at the end of September 2009 to a joint HTA/Arthritis Research UK call in April 2009 for a trial of anti-TNF in the treatment of JIA-Uveitis. This has been successful, subject to successful response to the reviewers’ comments and approval of costings. Detailed longitudinal feasibility will be conducted through the MCRN CTU and the respective Research Networks before site selection is finalised. Supply of the Investigational Medicinal Product and placebo will be from Abbott in this Investigator-led trial. Trial Protocol is currently (June 2010) being finalised based on the detailed study proposal which has been approved and application for MHRA approval to conduct the trial, Ethical / R&D approval and UK CRN Network Portfolio adoption.