EUCTR2010-023856-97-PL进行中（未招募）不适用
A Multicenter, Single-Arm, Open-Label, Study to Evaluatethe Immunogenicity and Pharmacokinetics of BIIB019,Daclizumab High Yield Process (DAC HYP), PrefilledSyringe Administered by Subcutaneous Injection inSubjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •Main Inclusion Criteria
- •1. Ability 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.
- •2. Aged 18 to 65 years old, inclusive, at the time of informed consent.
- •3. Must have a confirmed diagnosis of RRMS according to McDonald criteria, and a previous cranial MRI demonstrating lesion(s) consistent with MS.
- •4. Must have a baseline EDSS between 0.0 and 5.0.
- •5. Must have had 1 or more clinical relapses within the previous 2 years.
- •Inclusion Criteria for 3-Year Treatment Extension
- •1. Must have been compliant with the 205MS302 protocol during the initial 24-week treatment period and the 20-week washout period.
- •2. Must resume DAC HYP treatment =12 weeks after completion of the washout period
- •Inclusion Criteria for the TP-DI Sub-Study
- •1. Compliance with the 205MS302 protocol during the initial 24-week treatment period and through Week 40 of the 20-week washout period.
- •2. Must agree to resume DAC HYP treatment =12 weeks after
- •completion of the washout period
- •3. Must have normal LFT results (total bilirubin =1.5 × ULN, ALT/AST = 2 × ULN, and prothrombin time/partial thromboplastin time =1.2 ×
- •4. Must have estimated creatinine clearance >60 mL/min.
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •1. Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- •2. History of malignancy.
- •3. History of severe allergic or anaphylactic reactions.
- •4. History of abnormal laboratory results that is indicative of any significant major disease that would preclude administration of DAC
- •5. History of human immunodeficiency virus or other immunodeficient conditions.
- •6. MS relapse that has occurred within the 30 days prior to Day 1 AND/OR the subject has not stabilized from a previous relapse prior to
- •7. History of, or positive screening test for hepatitis C or hepatitis B infection.
- •8. Varicella or herpes zoster virus infection within 6 weeks before screening.
- •9. Exposure to varicella zoster virus within 21 days before screening.
- •10. Any of the following abnormal blood tests at screening:
- •hemoglobin =9.0 g/dL, platelets =100 x 109/L ,lymphocytes =1.0 x 109/L, neutrophils =1.5 ? 109/L
- •(ALT)/(ALT/SGPT), (AST)/ (AST/SGOT), or (GGT) =2 ×ULN)
- •serum creatinine =ULN
- •Treatment History
- •Any previous treatment with daclizumab or other anti-CD25 monoclonal antibody, total lymphoid irradiation, cladribine, T-cell or T-cell receptor
- •vaccination or any therapeutic monoclonal antibody, except natalizumab.
- •Any live virus vaccine within the 4 weeks prior to Day 1.
- •12. Infections requiring hospitalization or IV antibiotics within the 8 weeks prior to Day 1.
- •13. Elective surgery performed within the 2 weeks prior to Day 1 or scheduled through the end of the study.
- •14. Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to Day 1.
- •15. Treatment with mitoxantrone, cyclophosphamide, fingolimod, or
- •natalizumab within 1 year prior to Day 1.
- •16. Treatment with any of the following medications or procedures within the 6 months prior to Day 1:
- •cyclosporine
- •azathioprine
- •methotrexate
- •mycophenolate mofetil
- •IV immunoglobulin (IVIg)
- •Plasmapheresis/ cytapheresis
- •17. Treatment with any of the following medications within the 30 days prior to Day 1:
- •IV or oral corticosteroid treatment
- •glatiramer acetate
- •18. For subjects currently taking valproic acid, carbamazepine,
- •lamotrigine, or phenytoin:
- •Treatment with any of these agents = 6 months prior to study entry
- •Treatment with 2 or more of these agents for more than 6 months prior to study entry are excluded unless they reduce to =1 agent prior to study entry.
- •Dose escalations of one of these agents within the 6 months prior to study entry are excluded
- •Current treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry .
- •Exclusion Criteria for 3-Year Treatment Extension
- •1. Subjects who permanently discontinued DAC HYP treatment in Study 205MS302 for any reason prior to the 20 week washout period.
- •2. ALT/SGPT, (AST/SGOT), or GGT =2xULN within 7 days prior to reinitiation of DAC HYP.
- •Additional Exclusion Criteria for Specific TP-DI Sub-Study
- •Subject permanently discontinued DAC HYP treatment in Study 205MS302 for any reason prior to Week 40.
- •Subject is positive for NAbs at Week 36.
- •Subject is on a regimen of therapeutic anticoagulation.
- •Subject has narrow angle glaucoma.
- •Use of any drug or supplement that inhibits or induces CYP1A2,
- •CYP2C9, CYP2C19, CYP2D6, or CYP3A activity within 14 days or 5 halflives (whichever is longer) before the first dose of probe-drug cocktail.
- •Consumption of grapefruit or grapefruit-conta
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