EUCTR2009-012500-11-DK进行中（未招募）不适用
Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE
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
- 1,800
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 for this study, candidates must meet the following
- •eligibility criteria prior to randomization or at the timepoint specified in
- •the individual criteria listed below:
- •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. Must be 18 to 55 years of age, inclusive, at the time of consent.
- •3. Must have a confirmed diagnosis of RRMS according to McDonald
- •criteria, numbers 1 through 4 (Polman et al, 2005), and a cranial MRI
- •demonstrating lesion(s) consistent with MS (it is not necessary to obtain a current scan if a scan performed previously is available; if a previous scan is not available, then the baseline scan may be used).
- •4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- •5. Must meet one of the following disease activity-related criteria:
- •a) Two or more clinical relapses within the previous 3 years with at least
- •1 clinical relapse in the 12 months prior to randomization.
- •b) One or more clinical relapses and 1 or more new MRI lesions (Gd+
- •and/or T2 hyperintense lesion) within the previous 2 years with at least
- •one of these events in the 12 months prior to randomization. The new
- •MRI lesion must be distinct from one associated with the clinical relapse.
- •The baseline MRI may be used to satisfy this criterion.
- •Note: For inclusion purposes, a clinical relapse is defined as neurologic
- •signs and/or symptoms documented in the medical record of at least 24 hours duration that are determined by the Investigator or the Treating Neurologist as consistent with an MS relapse. Time since relapse should be measured from the time of relapse onset. When inclusion is based on a new MRI lesion, activity must be verified by the central MRI reading center.
- •6. Women of childbearing potential must be willing to practice effective
- •contraception during the study and be willing and able to continue
- •contraception for 4 months after their last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1800
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Diagnosis of primary progressive, secondary progressive, or
- •progressive relapsing MS (as defined by Lublin and Reingold, 1996).
- •2.Known intolerance, contraindication to, or history of non compliance
- •with Avonex 30 mcg.3.History of malignancy; however, subjects with a
- •history of excised or treated basal cell carcinoma or fewer than 3
- •squamous cell carcinomas are eligible to participate in this
- •study.4.History of severe allergic or anaphylactic reactions.
- •5.Known hypersensitivity to study drugs or their excipients.6.History of
- •abnormal laboratory results that are indicative of any significant cardiac,
- •endocrine, hematological, hepatic, immunologic, metabolic, urologic,
- •pulmonary, gastrointestinal, dermatologic, psychiatric, renal,
- •neurological (other than MS), and/or other major disease that would
- •preclude administration of DAC HYP or Avonex.7.History of human
- •immunodeficiency virus (HIV) or other immunodeficient conditions.
- •8.History of drug or alcohol abuse within the 2 years prior to
- •randomization.9.History of seizure disorder or unexplained blackouts OR
- •history of a seizure within 6 months prior to Baseline. 10.History of
- •suicidal ideation or an episode of clinically severe depression within 3
- •months prior to Day 1. Subjects receiving ongoing antidepressant
- •therapy will not be excluded from the study unless the medication has
- •been increased within the 6 months prior to Baseline.11.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.12.Known history of, or positive screening test result for
- •hepatitis C virus or hepatitis B virus. 13.Varicella or herpes zoster virus
- •infection or any severe viral infection within 6 weeks before
- •screening.14.Exposure to varicella zoster virus within 21 days before
- •screening.15.Any of the following abnormal blood tests at screening:
- •hemoglobin =9.0 g/dL
- •platelets =100 x 10^9/L
- •lymphocytes =1.0 x 10^9/L
- •neutrophils =1.5 x 10^9/L
- •alanine aminotransferase/serum glutamate pyruvate transaminase
- •(ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic
- •transaminase (AST/SGOT), or gamma glutamyl-transferase =2 times the
- •upper limit of normal (ULN)
- •serum creatinine =ULN
- •16.Any previous treatment with daclizumab or other anti-CD25
- •monoclonal antibody.17.Any type of live virus vaccine from 4 weeks
- •before randomization.18.Infection requiring hospitalization or
- •intravenous (IV) antibiotics within 8 weeks before
- •randomization.19.Elective surgery performed from 2 weeks prior to
- •randomization or scheduled through end of the study.
- •20.Treatment with another investigational drug or approved therapy for
- •investigational use within the 6 months prior to randomization.21.Prior
- •treatment with the any of the following:
- •total lymphoid irradiation• cladribine• T cell or T cell receptor
- •vaccination• any therapeutic monoclonal antibody, except natalizumab
- •22.Prior treatment with mitoxantrone, cyclophosphamide, fingolimod, or
- •natalizumab within 1 year prior to randomization.23.Prior treatment
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