EUCTR2009-012500-11-SE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
- •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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