EUCTR2013-002318-11-IT进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 142
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
- •To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization (Day 1) or at the timepoint specified in the individual eligibility criterion listed:
- •1. Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, as per local regulations.
- •2. Males and females aged from 10 to less than 18 years old at the time of informed consent or assent.
- •3. Must have a body weight of =30 kg.
- •4. Must have a diagnosis of RRMS (consensus definition for pediatric RRMS
- •[Krupp 2007]).
- •5. Must be ambulatory with a baseline EDSS score between 0 and 5.5, inclusive.
- •6. Must have experienced at least 1 relapse within the last 12 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.
- •7. 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.
- •8. 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 142
- •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
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of randomization (Day 1) or at the timepoint specified in the individual criterion listed:
- •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. 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.
- •3. History of premalignant or malignant disease. Subjects with basal cell carcinoma that has been completely excised prior to screening will remain eligible.
- •4. History of severe allergic or anaphylactic reactions, or known drug hypersensitivity.
- •5. 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.
- •6. 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.
- •7. History of human immunodeficiency virus.
- •8. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to Day 1.
- •9. 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.
- •10. History or positive test result at Screening for hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]). Subjects with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody [HBsAb] and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb IgG, and positive HBcAb) are eligible to participate in the study (definitions are based on the Centers for Disease Control and Prevention [CDC]’s interpretation of the hepatitis B serology panel [CDC 2007]; Appendix 4, Section 25]).
- •11. Any of the following abnormal blood test results at Screening:
- •- ALT, AST, or gamma glutamyl transferase (GGT) =2 × ULN
- •- leukocytes <3500/mm3
- •- eosinophils >0.7 × 103/µL or >0.7 GI/L
- •12. Any of the following abnormal urine tests at Screening confirmed by a second urinalysis approximately 2 weeks later:
- •- proteinuria (1+ or greater)
- •- hematuria, without known etiology
- •- glycosuria, without known etiology
- •Note: If a subject has a positive test at Screening and the etiology is known (e.g., due to menses or urinary tract infection in the case of hematuria or due to recent steroid use or elevated serum glucose in the case of glycosuria), a repeat test is not required.
- •Treatment history
- •13. Any previous treatment with Fumaderm® or BG00012.
- •14. Prior treatment with any of the following:
- •- total lymphoid irradiation
- •- cladribine
- •- T-cell or T-cell receptor vaccinati
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