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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 06 Apr 2020

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Juvenile rheumatoid arthritis; Uveitis
  • Focus Therapeutic Use
  • Acronyms SYCAMORE

    • Most Recent Events

    • 07 Jun 2019 Status changed from discontinued to completed.
    • 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.
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