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)

• DOI: 10.1186/1745-6215-15-14
• Publication Date: 2014-01-09T16:01:48Z
• Authors: Athimalaipet V Ra...; Andrew D Dick; Diana Benton; Sandrine Compeyro...; Dalia Dawoud; Ben Hardwick; Helen Hickey; Dyfrig Hughes; Ashley Jones; Patricia Woo; Clive Edelsten; Michael W Beresford
• Keywords: Time Factors; Adolescent; Cost-Benefit Analysis; Anti-Inflammatory Agents; 610; Medicine (miscellaneous); Antibodies, Monoclonal, Humanized; Drug Costs; Uveitis; Study Protocol; 03 medical and health sciences; 0302 clinical medicine; Clinical Protocols; London; Humans; Pharmacology (medical); Child; Adalimumab; Arthritis, Juvenile; 3. Good health; Methotrexate; Treatment Outcome; Research Design; Child, Preschool; Drug Therapy, Combination

Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. Children with JIA are at risk of inflammation uvea eye (uveitis). Overall, 20% to 25% paediatric uveitis associated JIA. Major factors for development oligoarticular pattern arthritis, an age onset less than seven years age, and antinuclear antibody positivity. In initial stages mild moderate asymptomatic. This has led current practice screening all children uveitis. Approximately 12% 38% patients develop following arthritis. 30% 50% JIA-associated structural complications present diagnosis. Furthermore about 75% those severe will eventually visual impairment secondary ocular such as cataract glaucoma. Defining severity now possible Standardised Uveitis Nomenclature (SUN) guidelines, modified incorporate consensus end point outcome criteria into design randomised trials. Despite therapeutic options (pre-biologics) 10% 15% may bilateral certified legally blind. To date, there remains no controlled trial evidence benefits biologic therapy. study randomise 154 aged 2 18 active (despite methotrexate (MTX) treatment least 12 weeks). All participants be treated months, follow up 3 from randomisation (continuing on MTX throughout). receive a stable dose addition either adalimumab (20 mg/0.8 ml <30 kg or 40 weighing 30 more, subcutaneous (s/c) injection every weeks based body weight), placebo (0.8 appropriate according weight) s/c weeks. first that assess clinical effectiveness, safety cost effectiveness combination juvenile ISRCTN10065623