EUCTR2014-005003-24-CZ进行中（未招募）1 期
Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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 Screening 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 in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parent or legal guardian, as appropriate, as per local regulations.
- •2. Male and female subjects aged 10 to 17 years old, inclusive, at the time of informed consent.
- •3. Must have a body weight of =30 kg at Screening and Day 1.
- •4. Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) [Polman 2011] and International Pediatric Multiple Sclerosis Study Group criteria for pediatric MS (2013) [Krupp 2013].
- •5. Must be ambulatory, with a converted Kurtzke baseline EDSS score between 0 and 5.0, inclusive.
- •6. Must have experienced =1 relapse in the 12 months prior to Screening or =2 relapses in the 24 months prior to Screening.
- •7. Must agree to be without treatment for 8 weeks prior to Day 1.
- •8. Sexually active subjects of reproductive potential must practice effective contraception during the study and for at least 30 days after their last dose of study treatment. For further details of contraceptive requirements for this study, refer to the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •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 Screening or at the timepoint specified in the individual criterion listed:
- •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, and neuromyelitis optica), 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 to DMF or fumaric acid esters.
- •5. History of any clinically significant cardiovascular, dermatologic, endocrinologic, GI, hematologic, immunologic, growth, developmental, pulmonary, psychiatric, neurologic (other than MS), renal, urologic, and/or other major disease that may confound safety or efficacy assessment.
- •6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to Screening.
- •7. Any of the following abnormal blood tests at Screening:
- •- alanine transaminase (ALT)/serum glutamic pyruvic transaminase (SGPT), AST/serum glutamic oxaloacetic transaminase (SGOT), or gamma glutamyl transferase (GGT) =2 times the upper limit of normal
- •- leukocytes <3500/mm3
- •- absolute lymphocyte count - eosinophils >0.7 × 103/µL or >0.7 GI/L
- •8. Any of the following abnormal urine tests at Screening confirmed by a second urinalysis 2 weeks later:
- •- proteinuria (1+ or greater) and/or spot protein/creatinine ratio (with AM void) >0.2 mg. Note: Documented benign proteinuria is not exclusionary.
- •- hematuria, without known etiology (e.g., urinary tract infection or menses)
- •- glycosuria, without known etiology (e.g., recent steroid use or elevated serum glucose)
- •9. History of or positive test result at Screening for human immunodeficiency virus.
- •10. History of 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 immunoglobulin G, and positive HBcAb) are eligible to participate in the study (definitions are based on the US Centers for Disease Control and Prevention’s interpretation of the hepatitis B serology panel [CDC 2007]).
- •Treatment History
- •11. Any previous treatment with Fumaderm® or BG00012.
- •12. 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
- •13. Prior treatment with any of the following medications within the 12 months prior to the
研究者
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