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SYCAMORE

Randomised controlled trial of the clinical effectiveness, SafetY and Cost effectiveness of Adalimumab in combination with MethOtRExate for the treatment of juvenile idiopathic arthritis associated uveitis

SYCAMORE

Randomised controlled trial of the clinical effectiveness, SafetY and Cost effectiveness of Adalimumab in combination with MethOtRExate for the treatment of juvenile idiopathic arthritis associated uveitis
Funding NIHR HTA and Versus Arthritis
Portfolio Paediatric, foetal and maternal health
Interventions Medicine
Randomised Yes
Status Completed
Start Date 01-Aug-2011

Juvenile idiopathic arthritis (JIA) is the name for a type of arthritis that primarily affects young people and whose cause is unknown. ‘Arthritis’ means inflammation of the joints, but in JIA the inflammation could also affect the eyes and internal organs. Around 30-40% of children with JIA are at risk of inflammation of the uvea in the eye, known as uveitis. In one third of the children who develop uveitis, the disease is of significant severity to cause visual loss, cataracts, increased pressure in the eye and blindness. The purpose of the study was to look at how effective the use adalimumab in combination with methotrexate is compared to using methotrexate (MTX) alone for the treatment of JIA- associated uveitis. Participants were ramdomised to get standard treatment of MTX with a placebo or standard treatment of MTX with adalimumab. Participants took their treatment for a maximum of 18 months

Publications

  • Hughes D, Ramanan A, Jones A, Wood E, Williamson P, Dick A, Compeyrot Lacassagne S, Hickey H, Hardwick B, Beresford M, Culeddu G, Woo P, Plumpton C, Mckay A. Cost-effectiveness analysis of adalimumab for the treatment of uveitis associated with Juvenile Idiopathic Arthritis. Ophthalmology, accepted.
  • Ramanan AV, Dick AD, Benton D, Compeyrot-Lacassagne S, Dawoud D, Hardwick B, Hickey H, Hughes D, Jones A, Woo P, Edelsten C, Beresford MW; SYCAMORE Trial Management Group. A randomised controlled trial of the clinical effectiveness, safety and cost-effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis (SYCAMORE Trial). Trials. 2014 Jan 9;15:14.
  • Ramanan AV, Dick AD, Jones AP, Hughes DA, McKay A, Rosala-Hallas A, Williamson PR, Hardwick B, Hickey H, Rainford N, Hickey G, Kolamunnage-Dona R, Cuyleddu G, Plumpton C, Wood E, Compeyrot-Lacassagne S, Woo P, Edelsten C & Beresford MW. Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: a RCT. Health Technology Assessment Volume: 23, Issue: 15, April 2019.
    1. https://doi.org/10.3310/hta23150
  • Ramanan AV, Dick AD, Jones AP, McKay A, Williamson PR, Lacassagne SC, Hardwick B, Hickey H, Hughes D, Woo P, Benton D, Edelsten C, Beresford MW for the SYCAMORE Study Group. (2017) Adalimumab plus methotrexate for uveitis in Juvenile Idiopathic Arthritis. NEJM 376:1637-1646.
    1. https://doi.org/10.1056/NEJMoa1614160