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
Phase of Trial: Phase II/III
Latest Information Update: 21 Jul 2017
At a glance
- Drugs Adalimumab (Primary)
- Indications Juvenile rheumatoid arthritis; Uveitis
- Focus Therapeutic Use
- Acronyms SYCAMORE
- 21 Jul 2017 According to an AbbVie media release, the Independent Data Safety and Monitoring Committee (IDSMC) recommended unmasking the trial early after 90 randomized patients with active JIA-associated uveitis showed that HUMIRA combined with methotrexate controlled ocular inflammation better and was associated with a significantly lower rate of treatment failure than placebo.
- 21 Jul 2017 According to an AbbVie media release, The review of the marketing authorization application (MAA) is being conducted under the centralized licensing procedure. A marketing authorization decision is anticipated by September. If approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
- 21 Jul 2017 According to an AbbVie media release, based on the results from this trial, the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for HUMIRA (adalimumab) for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.