A three-part multicenter study, with a randomized, doubleblind, placebo controlled, withdrawal design in Part II to assess efficacy, safety, and tolerability of ACZ885 (antiinterleukin-1ß monoclonal antibody) in patients with Muckle-Wells Syndrome

ovartis Pharma Services AG0 个研究点目标入组 35 人开始时间: 2012年3月9日最近更新: 2012年3月20日

适应症

试验速览

暂无简介。

•Molecular diagnosis of NALP3 mutations and clinical picture resembling Muckle-Wells Syndrome.
•Muckle-Wells Syndrome patients who participated in the CACZ885A2102 study will have the option to participate in this study upon disease flare
•Muckle-Wells Syndrome patients requiring medical intervention either untreated or treated (i.e. under ACZ885, anakinra, or any other investigational IL-1 blocking therapy).
•Other protocol-defined inclusion criteria may apply.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 5
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 29
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•History of being immunocompromised, including a positive HIV at screening test result.
•No live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
•History of significant medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial.
•History of recurrent and/or evidence of active bacterial, fungal, or viral infections.
•Positive tuberculin skin test at 48 to 72 hours after administration at the screening visit or within 2 months prior to the screening visit, according to national guidelines.
•Other protocol-defined exclusion criteria may apply

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