SYCAMORE
Research type
Research Study
Full title
Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis.
IRAS ID
70834
Eudract number
2010-021141-41
ISRCTN Number
n/a
Research summary
Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. Children with JIA also are at risk of inflammation of the uvea in the eye (uveitis). Overall, 20-25% of all paediatric uveitis is associated with JIA. Despite current screening and therapeutic options (pre-biologics) 10-15 % of children with JIA associated uveitis may eventually develop bilateral visual impairment and are certified legally blind. It is therefore critical to find more effective therapeutic interventions. Methotrexate (MTX) is well established as the first-line disease modifying agent in the management of JIA. However, up to 15-50% of children will have refractory uveitis in spite of optimal therapy with methotrexateThis trial will compare the clinical effectiveness of adalimumab in combination with methotrexate (MTX) versus MTX alone, with regard to controlling disease activity in refractory uveitis associated with juvenile idiopathic arthritis (JIA). 154 patients aged 2-18 inclusively will be randomised from 14 tertiary care centres throughout the UKParticipants will be treated in the study for a maximum period of 18 months. During this time patients will receive subcutaneous injections of either Adalimumab or Placebo at 2 weekly intervals. All patients will continue to receive a stable dose of Methotrexate throughout the 18 month period.After the 18 month treatment period participants will be followed up for a further 18 months to determine sustained effectiveness (remission) and safety over and above ongoing MTX therapy.
REC name
London - Hampstead Research Ethics Committee
REC reference
11/LO/0425
Date of REC Opinion
24 Jun 2011
REC opinion
Further Information Favourable Opinion