EUCTR2016-004223-23-FR
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2017年2月13日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ovimmune SA
- 入组人数
- 10
- 状态
- 进行中（未招募）
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Patients of both genders, aged from birth to \<18 years
- •Confirmed sJIA or high presumption of sJIA
- •Diagnosis of active MAS confirmed by the treating rheumatologist, having ascertained the followings:
- •Febrile patient presenting with:
- •\- Ferritin \> 684 ng/mL
- •and any two of
- •\- Platelet count \= 181 x10^9/L
- •\- AST levels \> 48 U/L
- •\- Triglycerides \> 156 mg/dL
- •\- Fibrinogen levels \= 360 mg/dL.
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.
- •Patients who have another concomitant disease or malformation severely affecting the cardiovascular, pulmonary, CNS, liver or renal function that in the opinion of the Investigator may significantly affect likelihood to respond to treatment and/or assessment of NI\-0501 safety.
- •History of hypersensitivity or allergy to any component of the study drug.
- •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.
结局指标
主要结局
未指定
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