EUCTR2006-003696-12-BG进行中（未招募）不适用
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - DEFINE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,011
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.Must give written informed consent and any authorizations required by local law (e.g.,Protected Health Information [PHI]).
- •2. Aged 18 to 55 years old, inclusive, at the time of informed consent.
- •3. Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4
- •(Polman et al, 2005).
- •4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- •5. Must have experienced at least 1 relapse within the 12 months prior to randomization,with a prior brain MRI demonstrating lesion(s) consistent with MS or show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
- •6. Male subjects and female subjects of child-bearing potential must be willing to 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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical History
- •1. 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.
- •2. Unable to perform the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, and PASAT 3.
- •3. Unable to perform visual function tests.
- •4. History of malignancy, unless an exception is granted by the Biogen Idec Medical Director. (Subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- •5. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- •6. History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or
- •other major disease that would preclude participation in a clinical trial.
- •7. History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS) and/or other major disease that would preclude participation in a clinical trial.
- •8. History of human immunodeficiency virus (HIV).
- •9. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
- •10. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
- •11. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
- •12. Any of the following abnormal blood tests at screening:
- •alanine transaminase/serum glutamate-pyruvate transaminase (ALT/SGPT), or
- •aspartate transaminase/serum glutamic-oxaloacetic transaminase (AST/SGOT), or
- •gamma-glutamyl-transferase (GGT) =2 times the upper limit of normal (ULN)
- •leukocytes <3500/mm3
- •eosinophils >0.7 × 10³/µL or >0.7 GI/L.
- •13. Any of the following abnormal urine tests at screening confirmed by the second urinalysis 2 weeks later:
- •proteinuria (1+ or greater)
- •hematuria, without known etiology (e.g. urinary tract infection, menses)
- •glycosuria, without known etiology (e.g. recent steroid use, elevated serum glucose)
- •Treatment History
- •14. Any previous treatment with FUMADERM® or BG00012 (FAG-201).
- •15. 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 TYSABRI®
- •(natalizumab) (see exclusion #17)
- •16. Prior treatment with any of the following within 1 year prior to randomization:
- •mitoxantrone
- •cyclophosphamide
- •17. Prior treatment with any of the following medications or procedures within the 6 months
- •prior to randomization:
- •cyclosporine
- •azathioprine
- •methotrexate
- •natalizumab (TYSABRI®)
- •intravenous immunoglobulin
- •plasmapheresis or cytapheresis.
- •18. Prior treatment with any of the following within the 3 months prior to randomization:
- •subcutaneous or oral glatiramer acetate
- •interferon-alpha
- •interferon-beta.
- •19. Treatment with any of the following medications within the 50 days prior to
- •randomization:
- •steroids (intravenous [IV] or oral corticosteroid treatment, including agents that may act through the corticosteroid pathwa
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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis - N/AEUCTR2006-003696-12-GRBiogen Idec Ltd.1,011
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