Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

ovartis Pharma K.K.0 个研究点目标入组 180 人开始时间: 2014年5月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•*Patient's written informed consent (or parent's written informed consent in case of pediatric patient) at screening
•*Male and female patients at least 2 years of age at the time of the screening visit
•*Confirmed diagnosis and active flare at randomization
•*CRP >10mg/L at randomization

•*Use of the following therapies (within varying protocol defined timeframes): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine, intravenous immunoglobulin, 6-Merceptopurine, azathioprine, cyclophosphamide, or chlorambucil, any other investigational biologics
•*History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in - situ cervical cancer), treated or untreated
•*Significant medical diseases, including but not limited to the following:
•a. History of organ transplantation
•b. Elevated liver enzymes >=2x ULN
•c. Increase in total bilirubin
•d. Serious hepatic disorder (Child-Pugh scores B or C)
•e. Chronic Kidney Disease
•f. Thyroid disease
•g. Diagnosis of active peptic ulcer disease
•h. Coagulopathy
•i. Significant CNS effects including vertigo and dizziness
•*Any conditions or significant medical problems which immunecompromise the patient and/or places the patient at unacceptable risk for immunomodulatory therapy
•*Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
•Other protocol defined inclusion/exclusion may apply

发起方

ovartis Pharma K.K.