EUCTR2016-002180-33-PL进行中（未招募）1 期
Multiple sclerosis therapy with transdermal myelin peptide stimulation.
Centrum Neurologii Krzysztof Selmaj0 个研究点目标入组 220 人开始时间: 2016年7月14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
- 220
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
- •The signing of informed consent to participate in the study
- •Women and men aged 18-60 years
- •RR diagnosis of MS according to the McDonald criteria 2010
- •State disability by EDSS 0 to 5.5
- •At least one relapse in the 12 months prior to screening
- •Neurologically stable during the 30 days prior to screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 220
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with diagnosis of SP MS and PP MS.
- •Pregnant patients
- •Patients with active immune system diseases, rheumatoid arthritis, scleroderma, Crohn's disease, etc.
- •Patients with bone marrow dysfunction, significant anemia, leukopenia, neutropenia, thrombocytopenia
- •Patients with active infection, bacterial, fungal or viral
- •Patients with AIDS
- •Patients with a history of syphilis, tuberculosis, hepatitis B or C
- •Patients vaccinated with a live or attenuated vaccine within 2 months prior to screening
- •Patients treatment with steroids or ACTH during the 30 days prior to screening
- •Patients treated in the past with interferon beta who discontinued treatment due to inefficiency
- •Patients with natalizumab treatment during the 6 months prior to screening
- •Patients treated with mitoxantrone 2 years before screening
- •Patients treated with fingolimod or dimethyl fumarate 2 months prior to screening
- •Patients with a history of cancer other than basal cell carcinoma
- •Patients with significant underlying cardiovascular, respiratory, gastrointestinal tract, kidney.
- •Patients who are unable to undergo MRI
- •Patients with a history of hyperactivity / allergy skin
研究者
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