EUCTR2015-000303-21-IT进行中（未招募）不适用
A Phase IV, interventional, multicenteR, double-blind, randomized, placebo-controlled study tO explore the onset of efficacy on Magnetic resonance disease activity of BG00012 (dimethyl fumarate) in Patients with relapsing-remitTing Multiple Sclerosis (PROMPT) - PROMPT
Biogen Idec Italia S.r.l.0 个研究点开始时间: 2015年4月1日最近更新:
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
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected information in accordance with local subject privacy regulations.
- •Patients with RRMS (McDonald criteria, 2010) who do not accept current injectable first-line DMTs
- •Age between 18 and 50 years at the time of informed consent.
- •MS onset within one year before enrollment (V0)
- •= 1 Gd+ lesions at a brain MRI scan performed within three months before enrollment(V0).
- •No previous disease modifying and/or immunosuppressive treatments for MS
- •Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- •Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
- •Previous disease modifying and/or immunosuppressive treatments for MS, including T-cell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
- •Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
- •History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
- •History of severe allergic or anaphylactic reactions or known drug hypersensitivity. Known allergy / hypersensitivity to Gadolinium.
- •History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
- •Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements.
- •History of or positive test result at screening for human immunodeficiency virus (HIV). Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
- •History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.
- •An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.
研究者
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