EUCTR2013-004291-35-BE进行中（未招募）1 期
A randomized, double-blind, placebo controlled study of canakinumab in patients with Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), with subsequent randomized withdrawal/ dosing frequency reduction and open-label long term treatment epochs
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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. Male and female patients >28 days but <2 years old at
- •the time of the screening visit will be enrolled in the open label arm only.
- •Confirmed diagnosis at screening
- •Active flare and CRP >10mg/L at randomization
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 105
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •- Significant medical diseases, including but not limited to the following:
- •a. History of organ transplantation
- •b. Elevated alanine aminotransferase (ALT) =3x ULN
- •c. Elevated aspartate aminotransferase (AST) =3x ULN
- •d. Increase in total bilirubin
- •e. Serious hepatic disorder (Child-Pugh scores B or C)
- •f. Chronic Kidney Disease
- •g. Thyroid disease
- •h. Diagnosis of active peptic ulcer disease
- •i. Coagulopathy j. Significant CNS effects including vertigo and dizziness
- •j. 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
研究者
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