Humira trials for children
As posted in August 2011 Olivia’s Vision has been asked to support both parents and children participating in the Humira trial.
Parents can contact us at email@example.com for more information. The Olivia’s Vision forums are also open to any parent considering participation, and for those parents and children taking part.
Below is a summary of the trial:
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 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 Methotrexate.
This 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 16 tertiary care centres throughout the UK Participants 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.