EUCTR2011-005550-57-PL进行中（未招募）不适用
A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
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
- •1.Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with a relapsing-remitting disease course.
- •2.Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits.
- •3.Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment or ACTH, 30 days prior to screening (Month -1) and between screening and baseline (Month 0) visits.
- •4.Subjects must have experienced one of the following:
- •At least one documented relapse in the 12 months prior to screening, or
- •At least two documented relapses in the 24 months prior to screening, or
- •One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
- •5.Subjects must be between 18 and 55 years of age, inclusive.
- •6.Women of child-bearing potential must practice an acceptable method of birth control.
- •7.Subjects must be able to sign and date a written informed consent prior to entering the study.
- •8.Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- •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 1400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects with progressive forms of MS.
- •2.Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
- •3.Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
- •4.Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
- •5.Use of cladribine within 2 years prior to screening.
- •6.Previous treatment with immunomodulators within 2 months prior to screening.
- •7.Previous use of GA or any other glatiramoid.
- •8.Chronic systemic corticosteroid treatment within 6 months prior to screening visit.
- •9.Previous total body irradiation or total lymphoid irradiation.
- •10.Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
- •11.Pregnancy or breastfeeding.
- •12.Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
- •13.A known history of sensitivity to Gadolinium.
- •14.GFR = 60 mL/min/ 1.73m2 at the screening visit
- •15.Inability to successfully undergo MRI scanning.
- •16.A known drug hypersensitivity to Mannitol.
- •17.Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
研究者
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