PER-080-09已完成未知
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 55（—）
入选标准
- •Ability to understand the purpose and risks of the study, give your signed and dated informed consent and authorization to use protected health information (PHl) in accordance with national and local patient privacy regulations.
- •Age between 18 and 55 years, inclusive, at the time of informed consent.
- •They must have a confirmed diagnosis of recurrent remitting MS, as defined by McDonald´s criteria # 1-4 (Polman et al, 2005; [Appendix 1]).
- •They must have an EDSS score between 0.0 and 5.0.
- •They must have experienced at least 2 medically documented relapses within the last 3 years with at least one of these relapses occurring within the last 12 months before randomization (Day I).
- •All male and female patients of childbearing age should use effective methods of contraception during the study; they must be willing and able to continue with the method of contraception for 3 months, after their last dose of study treatment. For additional details on the contraceptive requirements of this study, please see Section 15.5.3.
排除标准
- •Primary progressive, progressive secondary or progressive MS with relapse (as defined by Lublin and Reingold, 1996; (Appendix 2). These diseases require the presence of a continuous worsening of the clinical disease over a period of at least 3 months. Patients with these diseases may also have an overlapping relapse, but patients who relapse differ by the lack of clinically stable periods or clinical improvement.
- •History of severe allergy or anaphylactic reactions or known hypersensitivity
- •Previous treatment with interferon cannot exceed 4 weeks and patients must have discontinued interferon treatment 6 months before the baseline period.
- •Known allergy to any of the components of the BIIB017 formulation.
- •History of any clinically significant disease (as determined by the Researcher) such as heart disease, endocrine, immune, metabolic, urological, pulmonary, dermatological, psychiatric and renal neurological or other serious diseases that would exclude participation in a clinical study.
- •History of malignant disease, including solid tumors and hematologic malignancies (except basal cell carcinoma and squamous cell carcinoma of the skin that have been completely removed and considered cured).
- •History of seizure disorders or unexplained fainting Or a history of seizures within 3 months prior to the Baseline period.
- •History of suicidal ideas within 3 months prior to the Basal period or an episode of severe depression within 3 months prior to the Basal period A severe depression is defined as an episode of depression that requires hospitalization, or according to the Investigator´s criteria.
- •Clinically significant values of the abnormal electrocardiogram (ECG) as determined by the investigator.
- •Known history or positive results for Human Immunodeficiency Virus (HIV).
- •Positive result for the analysis of Hepatitis C virus (analysis for hepatitis C antibodies [HCV Ab]) or Hepatitis B virus (analysis for Hepatitis B Surface Antigen [HBsAg) and / or central antibody of Hepatitis B [HBcAb])
- •Abnormal blood tests in the selection period.
- •A relapse of MS that occurred within 50 days prior to randomization and / or the patient did not stabilize from a relapse prior to randomization (Day 1).
- •Any previous treatment with BIIB017.
- •History of hypersensitivity or intolerance to paracetamol (paracetamol), ibuprofen, naproxen or aspirin that would exclude the use of at least one of these medications during the study.
- •Treatment with other agents to treat the symptoms of MS or underlying disease
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