NCT00784836终止3 期
A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)
研究概览
简要总结
The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.
- •Must have a diagnosis of relapsing MS.
- •Must have a screening Expanded Disability Status Scale (EDSS) score between 0 and 6.0, inclusive.
- •All male subjects and female participants of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of Avonex.
排除标准
- •History of severe allergic or anaphylactic reactions.
- •Diagnosed with Primary progressive, secondary progressive, or progressive relapsing MS.
- •Known allergy to any component of the Avonex formulation.
- •History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease.
- •Subjects with history of malignant disease, including solid tumors and hematologic malignancies.
- •History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Day
- •History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day
- •Severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy.
- •Clinically significant abnormal electrocardiogram (ECG) values as determined by the investigator.
- •Known history of, or a positive test result for, human immunodeficiency virus (HIV).
- •Known history of, or a positive test result for hepatitis C virus.
- •Abnormal screening blood tests exceeding any of the limits defined below:
- •Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin.
- •Total white blood cell count (WBC) <3700 cells/mm
- •Platelet count <150,000 cells/mm
- •Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects
- •Serum creatinine >upper limit of normal (ULN)
- •Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN
研究组 & 干预措施
Avonex
Experimental
Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
干预措施: BG9418 (interferon beta 1-a) (Drug)
结局指标
主要结局
Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)
时间窗: assessed every 3 months up to 18 months
The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.
次要结局
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Planned for up to 18 months plus 30 days; actual study duration was 111 days.)
研究者
研究点 (2)
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