An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of immunogenicity
研究概览
简要总结
The study is designed to determine the effect of weekly intramuscular (IM) administration of 30 mcg Avonex (interferon beta 1a) on safety parameters and gadolinium (Gd) enhanced and T2-weighted cranial magnetic resonance imaging (MRI) lesions in Chinese patients with clinically diagnosed (using revised McDonald criteria) relapsing multiple sclerosis (MS).
详细描述
This is a multicenter, open-label, safety study to support registration of Avonex in China by providing data on the effect of weekly IM administration of 30mcg Avonex on safety parameters in Chinese patients with clinically diagnosed relapsing MS. This study will also include an intra-subject exploratory comparison of pre-treatment MRI (at -3 months and at month 0) and post -treatment MRI (at month 3 and month 6). Up to 60 subjects with relapsing forms of MS will be recruited to approximately 6 sites in China.
The study period will consist of screening, a 6 month open-label treatment period, and follow up at 30 days post-dosing. There will be a total of 8 clinic visits and 1 telephone contact.
Screening: will be determined 3 months +/- 7 days prior to subjects' first dose of Avonex on Day 1, at which time a screening MRI with and without Gd-enhancement will be performed.
Treatment Period: consists of eligible patients undergoing pre-dosing assessments and receiving the first dose of Avonex on day 1. Subjects will have a brain MRI within 48 hours prior to the first injection of Avonex.
Weekly doses of open-label Avonex 30mcg IM will be administered for 24 consecutive weeks for a total of 25 injections per subject. Subjects or their caregivers will be allowed to self-inject after successful completion of appropriate IM injection training.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand risks of study and provide informed consent.
- •Must be Chinese, aged 18 to 55 years inclusive at time of consent.
- •Must have diagnosis of relapsing MS of 3 months duration at time of screening visit.
- •Must have at least 1 documented MS attack within 3 years of Day
- •Must have EDSS score of 0 to 5 inclusive at screening visit.
- •All male subjects & female subjects of child-bearing potential must practice effective contraception during the study.
排除标准
- •Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS.
- •Have had a clinical MS attack within the 50 days prior to Day 1, and or the subject has not stabilized from a previous attack in the opinion of the Investigator.
- •The subject is unable to undergo a brain MRI scan for any reason.
- •The subject's screening and Day 1 MRIs are both normal (negative) for lesions consistent with MS (Gd-enhancing lesions are not required, but one of the 2 MRIs should be consistent with MS).
- •History of severe allergic or anaphylactic reactions.
- •Known allergy to any component of the Avonex Formulation.
- •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease.
- •Subjects with a history of malignant disease, including solid tumors, and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and considered cured).
- •History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Day
- •History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 6 months prior to Day
- •Note: subjects receiving ongoing antidepressant therapy will not be excluded from the study unless the medication has been increased within the 6 months prior to Day
- •Clinically significant abnormal ECG values as determined by the Investigator.
- •Known history of human immunodeficiency virus (HIV).
- •Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody HCV Ab) or hepatitis B virus (test for Hepatitis B surface Antigen HBsAg) and/or Hepatitis B Core Antibody (HBcAb).
研究组 & 干预措施
Active treatment
Interferon treatment for MS
干预措施: Avonex (Drug)
结局指标
主要结局
Assessment of immunogenicity
时间窗: 24 weeks
Incidence of depression
时间窗: 24 weeks
The number and proportion of subjects with adverse events (AEs)
时间窗: 24 weeks
Assessment of clinical laboratory parameters
时间窗: 24 weeks
Assessment of vital signs and physical examinations
时间窗: 24 weeks
Assessment of electrocardiogram (ECG)
时间窗: 24 weeks
Incidence of flu-like symptoms
时间窗: 24 weeks
Subject assessment of injection site pain
时间窗: 24 weeks
Clinical assessment of the injection site
时间窗: 24 weeks
次要结局
- Assess safety of Avonex by evaluating changes in the Expanded Disability Status Scale (EDSS) score over time(24 weeks)
- Number of Gd-enhancing lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment(at month 3 and month 6)
- Number of new or newly enlarging T2-weighted lesions on brain MRI scans taken after 3 and 6 months following Avonex treatment(at month 3 and month 6)
- Volume of T2-weighted lesions on brain MRI scans taken after 6 months following initiation of Avonex treatment(month 6)
- Assess pharmacodynamic response to Avonex by evaluating the change from baseline in serum levels of neopterin(24 weeks)