EUCTR2009-017003-28-IT进行中（未招募）不适用
Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome
BIOGEN-DOMPE` SR0 个研究点开始时间: 2010年4月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. They need to have a diagnosis of relapsing remitting MS according to Mc Donald revised criteria 2. They will be naive for any DMTs therapy and will undergo therapy with IFN- 1a due to their clinical features as required by nota 65 AIFA 3. They will be more than 18 years old 4. They will have and EDSS between 0 and 4.5. 5. No steroids for at least 1 month before starting IFN-1a therapy 6. All subjects must give informed consent
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Primary progressive, secondary progressive, or progressive relapsing multiple sclerosis 2. Concurrent DMTs 3. Steroids during the month before starting IFN- 1a therapy 4. Concomitant or in the previous year immunosuppressive therapies 5. History of alcohol or drug abuse within 2 years prior to randomization. 6. No resolution of a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomization 7. History of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease, that, in the opinion of the investigator, would preclude the administration of an IFN-β for the duration of the study 8. Presence of infectious or flu like symptoms in the week before the beginning of the study 9. Nursing mothers, pregnant women, and women planning to become pregnant while on study 10. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject`s ability to comply with the study protocol according to the Investigator and/or the Sponsor
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