CTRI/2010/091/000773已完成2 期
A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to determine the Safety and Efficacy of Dacluzimab HYP (DAC HYP) as a Monotherapy Treatment in subjects with Relapsing Remitting Multiple Sclerosis.Acronym: SELECT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen Idec
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Annualised relapse rate
研究概览
简要总结
The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52.We have approval to recruit up to 60 patients in India and the anticipated date to start recruitment in India will for 13 Oct 2009.Update:The screening was stopped in the study in Apr 2010 as the target number of patients was achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •MS subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline EDSS between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria: a.
- •Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS , OR b.
- •Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria existat the time of randomization:Medical History
- •Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS(as defined Lublin and Reingold, 1996 [Section 23]).
- •These conditions require thepresence of continuous clinical disease worsening over a period of at least 3 months.Patients with these conditions may also have superimposed relapses, but aredistinguished from relapsing-remitting patients by the lack of clinically stable periods orclinical improvement.
- •History of malignancy; however, subjects with a history of excised or treated basal cellcarcinoma or fewer than 3 squamous sell carcinomas are eligible to participate in thisstudy.
- •History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- •History of abnormal laboratory results that, in the opinion of the investigator, areindicative of any significant cardiac, endocrinologic, hematologic, hepatic,immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic,psychiatric, renal, neurologic (other than MS), and/or other major disease that wouldpreclude administration of DAC HYP.
- •History of human immunodeficiency virus (HIV) or other immunodeficient conditions.
- •History of drug or alcohol abuse (as defined by the Investigator) within the 2 years priorto randomization.
- •An MS relapse that has occurred within the 50 days prior to randomization AND/OR thesubject has not stabilized from a previous relapse prior to randomization.
- •Positive screening for active infection with Hepatitis B virus or Hepatitis C virus.
- •Varicella or herpes zoster virus infection or any severe viral infection within 6 weeksbefore Screening.
- •Exposure to varicella zoster virus within 21 days before Screening.
- •Any of the following abnormal blood tests at Screening:?
- •Hemoglobin ≤9.0 g/dL?
- •Platelets ≤100 × 109/L?
- •Lymphocytes ≤1.0 × 109/L?
- •Neutrophils ≤1.5 × 109/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.Treatment History
- •Any previous treatment with DAC HYP or Zenapax®.
- •Any of the following types of live virus vaccine from 4 weeks before randomization:measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, andnasal influenza vaccine.
- •Use of these vaccines, however, by other members of thesubject?s household does not affect the eligibility of subjects to enroll or continue in thestudy.
- •Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV)antibiotics within 8 weeks before randomization.
- •Elective surgery performed from 2 weeks prior to randomization or scheduled throughthe end of the study.
- •Prior treatment with the any of the following:?
- •total lymphoid irradiation?
- •cladribine?
- •mitoxantrone?
- •T-cell or T-cell receptor vaccination?
- •any therapeutic monoclonal antibody, except natalizumab or rituximab.
- •Prior treatment with cyclophosphamide or rituximab within 1 year prior torandomization.
- •Prior treatment with any of the following medications or procedures within the 6 monthsprior to randomization:?
- •natalizumab?
- •cyclosporine?
- •azathioprine?
- •methotrexate?
- •intravenous immunoglobulin (IVIg)?
- •plasmapheresis or cytapheresis.
- •Prior treatment with any of the following within the 3 months prior to randomization:?
- •SC or oral glatiramer acetate?
- •IFN-beta (subjects who are positive for neutralizing antibodies to IFN-beta mayreceive IFN-beta treatment up to 2 weeks prior to randomization).20.
结局指标
主要结局
Annualised relapse rate
时间窗: Week 52
次要结局
- a. Brain MRI measures (number of gd enhancing lesions, number of new or newly enlarging T2 hyperintense lesionsb. Proportion of relapsing subjectsc. Improving quality of life(Week 52)
研究者
研究点 (6)
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