EUCTR2016-004223-23-NL进行中（未招募）1 期
A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of NI-0501, an anti-interferon gamma (anti-IFN?) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) developing Macrophage Activation Syndrome/secondary HLH (MAS/sHLH)
ovimmune SA0 个研究点目标入组 10 人开始时间: 2018年2月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- •Patients of both genders, aged <18 years
- •Confirmed sJIA or high presumption of sJIA.
- •Diagnosis of active MAS confirmed by the treating rheumatologist
- •Patient presenting an inadequate response to high dose i.v. glucocorticoid treatment
- •Informed consent provided by the patient (as required by local law), or by the patient’s legally authorized representative(s) with the assent of patients who are legally capable of providing it, as applicable
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diagnosis of suspected or confirmed primary HLH or HLH consequent to a neoplastic disease.
- •Patients treated with Tocilizumab, Canakinumab or TNF inhibitors within 5 times of their defined half-life.
- •Active mycobacteria (typical and atypical), Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter and Leishmania infections.
- •Clinical suspicion of latent tuberculosis.
- •Positive serology for HIV antibodies.
- •Presence of malignancy.
- •Receipt of a BCG vaccine within 12 weeks prior to screening.
- •Receipt of live or attenuated live vaccines (other than BCG) within 6 weeks prior to screening.
研究者
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