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Can treatment with adalimumab reduce eye damage in children with JIA associated uveitis? (SYCAMORE)

Award Details

  • Principal Investigator
    Professor Athimalaipet Ramanan
  • Type of grant
    ZZZ-Clinical Studies
  • Amount Awarded
  • Institute
    United Bristol Healthcare NHS Trust
  • Location
  • Status
  • Start Date
  • Grant reference number
  • Condition
    Juvenile idiopathic arthritis

What are the aims of this research?

This clinical trial will find out how effective adding the drug adalimumab to methotrexate treatment is for treating children with severe uveitis. We want to know if this treatment is useful for preventing the serious complications that can arise from uncontrolled uveitis.

Why is this research important?

Juvenile idiopathic arthritis (JIA) is a type of arthritis that affects young people and whose cause is unknown. In JIA inflammation can affect the eyes and internal organs. Around 1 in 1000 children in the UK develop JIA. Of these around 30-40% are at risk of inflammation of the uvea, the middle layer of the eye; known as uveitis. This can lead to visual loss, cataracts, increased pressure in the eye and blindness. As the disease is silent there is an extensive screening programme to try to minimise the delay in diagnosis and help with early treatment.

The current treatments for uveitis include steroid eye drops and children with severe disease are treated with methotrexate. These treatments reduce inflammation which relieves the symptoms of uveitis and reduces the levels of permanent damage. Some research has shown that using drugs that block the action of the TNF protein (called anti-TNF drugs) can reduce symptoms of swollen joints in children with JIA. Adalimumab is an anti-TNF drug that may be effective in treating uveitis symptoms but this is yet to be shown in a clinical trial.

We will recruit 154 children with severe uveitis who will all receive methotrexate. The aim of this clinical trial is to examine how effective the addition of adalimumab is for treating their uveitis symptoms. To test this accurately we will compare these children with a group who are treated with methotrexate plus a treatment that looks exactly the same as the adalimumab but contains no medicine (called a ‘placebo’). Children will be randomly allocated to each treatment group.

How will the findings benefit patients?

If we show that adalimumab is effective in treating children with severe uveitis this would allow us to control the inflammation associated with this severe eye problem. This could help to reduce the number of children who develop serious visual problems from uncontrolled uveitis.

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