IRCT201612306135N8已完成3 期
Efficacy and safety of peginterferon beta-1a (CinnaGen) versus CinnoVex® (CinnaGen) in reducing the annualized relapse rate (ARR) in participants with relapsing-remitting multiple sclerosis: A phase III, randomized, parallel, non-inferiority study.
CinnaGen Pharmaceutical Company0 个研究点目标入组 168 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
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 years 至 50 years（—）
- 性别
- All
入选标准
- •Age 18-50 years
- •Relapsing-remitting multiple sclerosis (RRMS) (McDonald criteria 2010)
- •Expanded Disability Status Scale (EDSS) is 0–5
- •At least one relapse having occurred within the past 12 months
- •Subjects have refused alternative treatments and other available therapies
- •Ability to understand the purpose and risks of the study and provide signed and dated an informed consent
- •Negative pregnancy test for childbearing women
排除标准
- •Primary progressive, secondary progressive, or progressive- relapsing MS
- •Female subjects considering becoming pregnant while in the study or currently breastfeeding
- •Subjects for whom MRI was contraindicated, i.e., who had pacemakers or were allergic to gadolinium,...
- •Unwillingness or inability to comply with the requirements of the protocol
- •Pre-speci?ed laboratory abnormalities
- •History of any clinically significant that would preclude participation in a clinical trial
- •History of malignant disease (with the exception of squamous cell carcinomas of the skin that are cured)
- •History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline
- •History of suicidal ideation or an episode of severe depression within 3 months prior to Baseline
- •Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal
- •Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) greater than 2 times the upper limit of normal
- •Bilirubin greater than 1.5 times the upper limit of normal
- •Total white blood cell count (WBC) <4000 /mm3
- •Absolute Neutrophil Count (ANC) of < 1500 /mm3
- •Platelet count <120,000 c/mm3
- •Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects
- •Serum creatinine upper limit of normal lab value
- •An MS relapse that has occurred within the 30 days prior to randomization or the subject has not stabilized from a previous relapse prior
- •Elective surgery performed from 2 weeks prior or scheduled through the end of the study
- •Any prior treatment with Total Lymphoid Irradiation, Cladribine, T-cell Vaccine, Natalizumab, Rituximab, BIIB017, Fingolimod, Dimethyl fumarate, and Teriflunomide
- •Prior treatment within 1 with Cyclophosphamide– Mitoxantrone
- •Prior treatment within 6 months with Cyclosporine, Plasma exchange, Intravenous immunoglobulin (IVIG), Azathioprine, Methotrexate
- •Any prior treatment within 6 months with interferon
- •Prior treatment within 30 days prior with Systemic Corticosteroids
- •Prior treatment with Glatiramer Acetate within 4 weeks prior to randomization
- •Treatment with another investigational drug within the 6 months prior to randomization
- •Other reasons, that in the opinion of the investigator, made the subject unsuitable for enrolment
研究者
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