EUCTR2013-002318-11-DK进行中（未招募）1 期
Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
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
- •Key inclusion criteria:
- •- Must have a body weight of =30 kg.
- •- Must have a diagnosis of RRMS (consensus definition for pediatric RRMS [Krupp 2013]).
- •- Must be ambulatory with a baseline EDSS score between 0 and 5.5, inclusive.
- •- Must have experienced at least 1 relapse within the last 12 months
- •prior to Day 1, or at least 2 relapses within the last 24 months prior to
- •Day 1, with a prior brain MRI demonstrating lesions consistent with MS,
- •or show evidence of Gd enhancing lesions of the brain on an MRI
- •performed within the 6 weeks prior to Day 1.
- •- Must be neurologically stable, with no evidence of relapse within 50
- •days prior to Day 1 and no evidence of corticosteroid treatment within
- •30 days prior to Day 1.
- •- Subjects of childbearing potential who are sexually active must be
- •willing to practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their final dose of study treatment.
- •- Subjects who have completed Week 96 in Part 1
- •NOTE: Other protocol defined inclusion criteria may apply
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 132
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria:
- •- Primary progressive, secondary progressive, or progressive relapsing
- •MS (as defined by [Lublin and Reingold 1996]). These conditions require
- •the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have
- •superimposed relapses but are distinguished from relapsing remitting
- •subjects by the lack of clinically stable periods or clinical improvement.
- •- Disorders mimicking MS, such as other demyelinating disorders (e.g.,
- •acute disseminated encephalomyelitis), systemic autoimmune disorders
- •(e.g., Sjögren disease, lupus erythematosus), metabolic disorders (e.g.,
- •dystrophies), and infectious disorders.
- •- History of premalignant or malignant disease. Subjects with basal cell
- •carcinoma that has been completely excised prior to screening will
- •remain eligible.
- •- History of severe allergic or anaphylactic reactions, or known drug
- •hypersensitivity to DMF, fumaric acid esters or interferon B-1A (IFN ß-1a).
- •- History of abnormal laboratory results indicative of any significant
- •endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or any other major disease that would preclude participation in a clinical study.
- •- History of clinically significant cardiovascular, pulmonary, GI,
- •dermatologic, growth, developmental, psychiatric (including
- •depression), neurologic (other than MS), and/or other major disease
- •that would preclude participation in a clinical study.
- •- History of human immunodeficiency virus.
- •- An MS relapse that has occurred within 50 days prior to Day 1 AND/OR the subject has not stabilized from a previous relapse prior to Day 1.
- •- Other unspecified reasons that, in the opinion of the Investigator or
- •Biogen Idec, make the subject unsuitable for enrollment.
- •Key Treatment history
- •- Any previous treatment with Fumaderm (fumaric acid esters) or
- •- Prior treatment with any of the following: total lymphoid irradiation,
- •cladribine, T-cell or T-cell receptor vaccination, any therapeutic
- •monoclonal antibody, with the exception of rituximab or natalizumab
- •- Prior treatment with any of the following medications within the 12
- •months prior to Day 1: mitoxantrone, cyclophosphamide, rituximab
- •- Prior treatment with any of the following medications or procedures
- •within 6 months prior to Day 1: fingolimod, teriflunomide, natalizumab,
- •cyclosporine, azathioprine, methotrexate, mycophenolate mofetil,
- •laquinimod, IV immunoglobulin, plasmapheresis or cytapheresis
- •- Treatment with any of the following medications within 30 days prior
- •- steroids (IV or oral corticosteroid treatment, including agents that may act through the corticosteroid pathway [e.g., low dose naltrexone]), 4-aminopyridine or related products (except subjects on a stable dose of controlled-release fampridine for 3 months)
- •-any significant changes in medical history occuring after enrollment in Part 1
- •- subject who could not tolerate BG00012 in Part 1
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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