CTRI/2010/091/000254已完成3 期
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 β 1a) in Patients with Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 7
- 主要终点
- Annualized relapse rate (ARR)
研究概览
简要总结
This is a multicentric global trial with a sample size of 1500 patientsThe primary study objective is to test the superiority of DAC HYP compared to IFN-b-1a in preventing MS relapse in subjects with RRMS. We have obtained approval to recruit upto 50 patients in India and the anticipated date to start recruitment in India is as on 30-Sep-2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •Inclusion CriteriaTo be eligible for this study, candidates must meet the followingeligibility criteria prior to randomization or at the timepoint specified inthe individual criteria listed below:
- •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.
- •Must be 18 to 55 years of age, inclusive, at the time of consent.
- •Must have a confirmed diagnosis of RRMS according to McDonaldcriteria, numbers 1 through 4 (Polman et al, 2005), and a cranialMRI 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).
- •Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- •Must meet one of the following disease activity-related criteria:a) Two or more clinical relapses within the previous 3 years withat least 1 clinical relapse in the 12 months prior torandomization.ORb) One or more clinical relapses and 1 or more new MRI lesions(Gd+ and/or T2 hyperintense lesion) within the previous 2 yearswith at least one of these events in the 12 months prior torandomization.
- •The new MRI lesion must be distinct from oneassociated with the clinical relapse.
- •The baseline MRI may beused to satisfy this criterion.Note: For inclusion purposes, a clinical relapse is defined as neurologicsigns and/or symptoms documented in the medical record of at least 24hours duration that are determined by the Investigator or the TreatingNeurologist as consistent with an MS relapse.
- •Time since relapse should bemeasured from the time of relapse onset.
- •When inclusion is based on a newMRI lesion, activity must be verified by the central MRI reading center.
- •Male subjects and female subjects of childbearing potential must bewilling to practice effective contraception during the study and bewilling and able to continue contraception for 4 months after theirlast dose of study treatment.
排除标准
- •Exclusion CriteriaCandidates will be excluded from study entry if any of the followingexclusion criteria exist at randomization or at the timepoint specified in theindividual criteria listed below:Medical History
- •Diagnosis of primary progressive, secondary progressive, orprogressive relapsing MS (as defined by Lublin and Reingold,2001).
- •These conditions require the presence of continuous clinicaldisease worsening over a period of at least 3 months.
- •Patients withthese conditions may also have superimposed relapses, but aredistinguished from relapsing remitting patients by the lack ofclinically stable periods or clinical improvement.
- •Known intolerance, contraindication to, or history of non-compliance with Avonex 30 mcg.Note: Current or prior use of an approved IFN β preparation for MS,including Avonex, is allowed as long as the subject is currently appropriatefor Avonex treatment according to local prescribing information.
- •History of malignancy; however, subjects with a history of excisedor treated basal cell carcinoma or fewer than 3 squamous cellcarcinomas are eligible to participate in this study.
- •History of severe allergic or anaphylactic reactions.
- •Known hypersensitivity to study drugs or their excipients.
- •History of abnormal laboratory results that, in the opinion of theInvestigator, 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 wouldpreclude administration of DAC HYP or Avonex.
- •History of human immunodeficiency virus (HIV) or otherimmunodeficient conditions.
- •History of drug or alcohol abuse (as defined by the Investigator)within the 2 years prior to randomization.
- •History of seizure disorder or unexplained blackouts OR history ofa seizure within 6 months prior to Baseline.
- •History of suicidal ideation or an episode of clinically severedepression (as determined by the Investigator) within 3 monthsprior to Day
- •Subjects receiving ongoing antidepressant therapywill not be excluded from the study unless the medication has beenincreased within the 6 months prior to Baseline.
- •An MS relapse that has occurred within the 50 days prior torandomization AND/OR the subject has not stabilized from aprevious relapse prior to randomization.
- •Known history of, or positive screening test result for hepatitis Cvirus or hepatitis B virus.
- •Varicella or herpes zoster virus infection or any severe viralinfection within 6 weeks before 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 x 109/L?
- •lymphocytes ≤1.0 x 109/L?
- •neutrophils ≤1.5 x 109/L?
- •alanine aminotransferase/serum glutamate pyruvatetransaminase (ALT/SGPT), aspartate aminotransferase/serumglutamic oxaloacetic transaminase (AST/SGOT), orgamma-glutamyl-transferase ≥2 times the upper limit of normal(ULN)?
- •serum creatinine ≥ULNTreatment History
- •Any previous treatment with daclizumab or other anti-CD25monoclonal antibody.
- •Any type of live virus vaccine from 4 weeks before randomization,including but not limited to, measles/mumps/rubella vaccine,varicella zoster virus vaccine, oral polio vaccine, and nasalinfluenza vaccine.
- •Infection (viral, fungal, bacterial) requiring hospitalization orintravenous (IV) antibiotics within 8 weeks before randomization.
- •Treatment with another investigational drug or approved therapy forinvestigational use within the 6 months prior to randomization.
- •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
- •Prior treatment with mitoxantrone, cyclophosphamide, fingolimod,or natalizumab within 1 year prior to randomization.
- •Prior treatment with any of the following medications or procedureswithin the 6 months prior to randomization:?
- •cyclosporine?
- •azathioprine?
- •methotrexate?
- •mycophenolate mofetil?
- •intravenous immunoglobulin?
- •plasmapheresis or cytapheresis.
- •Treatment with any of the following medications within the 30 daysprior to randomization:?
- •IV corticosteroid treatment?
- •oral corticosteroid treatment?
- •glatiramer acetateNote: Subjects who are currently receiving an approved IFN β preparationare not required to washout from IFN β prior to randomization, but IFN βtreatment must be discontinued prior to randomization.
- •Initiation of treatment or dose adjustment of commercially-availableFampridine-SR within the last 90 days.Note: Subjects who have been on a stable dose of commercially-availableFampridine-SR for longer than 90 days are not excluded.
- •Use ofcompounded or other formulations of 4-aminiopyridine is excluded.Miscellaneous
- •Female subjects who are currently pregnant or breastfeeding.
- •Female subjects considering becoming pregnant while in the study.
- 另有 4 项未显示
结局指标
主要结局
Annualized relapse rate (ARR)
时间窗: 96 weeks
次要结局
- The secondary endpoints (rank ordered) for this study are: 1) Number of new or newly-enlarging T2 hyperintense lesions on brain MRI over 96 weeks 2) Change in Multiple Sclerosis Functional Composite (MSFC) score 3) Sustained disability progression defined by at least a 1.0-point increase on EDSS from baseline EDSS ≥1.0 that is sustained for 12 weeks or at least a 1.5-point increase on the EDSS from baseline EDSS <1.0 that is sustained for 12 weeks 4) Change in Multiple Sclerosis Impact Scale 29 (MSIS-29) physical score 5) The proportion of subjects who are relapse-free(96 weeks)
研究者
研究点 (7)
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