NCT02753088已完成3 期
International, Multicentre, Double-blind, Placebo-controlled, Comparative, Randomized Study to Compare Efficacy and Safety of the Generic Drug BCD-063 (CJSC "BIOCAD", Russia) and Copaxone®-Teva ("Teva Pharmaceutical Industries Limited", Israel) in Patients With Relapsing-remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 158
- 主要终点
- Cumulative Unique Activity lesions
研究概览
简要总结
The objective of the clinical study of the medicinal product for medical use: to compare efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis.
Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to March 23, 2016.
Number of patients, involved into the study of the medicinal product for medical use: 158 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously diagnosed multiple sclerosis (MS, McDonald criteria 2005);
- •Disease more, than 1 year prior to inclusion;
- •Presence of 1 relapse previously OR at least 1 Gd+ lesion in T1 regimen;
- •EDSS 0-5,5;
- •Absence of exacerbations for 4 weeks prior to inclusion;
- •Readiness of patients (both genders) to use reliable methods of contraception (at least 1 barrier method in combination with: spermicides, intrauterine device/oral contraceptives)
排除标准
- •Secondary progressive and primary progressive forms of multiple sclerosis;
- •Other diseases (except multiple sclerosis), which may affect the assessment of the severity of the symptoms of the underlying disease: mask, amplify, modify the symptoms of the underlying disease or cause the clinical manifestations and changes in the data of laboratory and instrumental methods of investigation similar to those of multiple sclerosis;
- •Any acute or chronic infection in the acute stage;
- •Verified HIV, hepatitis B and C, syphilis;
- •Metabolic abnormalities (disorders), which manifest themselves as:
- •raising the general level of creatinine is more than 2 times over the upper limit of the normal range;
- •increase in transaminases (ALT, AST) or gamma-glutamyltransferase more than 2.5 times over the upper limit of the normal range;
- •Violation of bone marrow function as reducing the total number of leukocytes <3000 /mcl, or a platelet count <125000 /mcl, hemoglobin concentration reduction, or <100 g / l;
- •EDSS> 5,5 points;
- •Liver disease in the stage of decompensation;
- •Congestive heart failure, or not controlled by a drug therapy angina or arrhythmia;
- •Pregnancy, breast-feeding or planned pregnancy during the study period;
- •Use of any time prior to study any drug for modifying multiple sclerosis: interferon beta-1a, interferon beta-1b, glatiramer acetate, azathioprine, corticosteroids and immunomodulators (except for treating exacerbations corticosteroids), drugs and monoclonal antibodies, cytotoxic and / or immunosuppressive drugs, including, but not limited to drugs: mitoxantrone, cyclophosphamide, cyclosporine, fingolimod, cladribine; or total lymphoid irradiation system;
- •System (IV, oral) corticosteroids within 30 days prior to the screening visit;
- •Intolerance or allergy to glatiramer acetate, mannitol or other components of the BCD-063 preparations or Copaxone®-Teva;
- •History of drug addiction, alcoholism and abuse of drugs;
- •Contraindications to MRI (gadolinium allergic to or intolerant of closed spaces, any renal failure, which may interfere with the removal of gadolinium - an acute or chronic renal failure);
- •Any malignancies, including in anamnesis;
- •Vaccination within 4 weeks prior to study entry (prior to randomization);
- •Participation in any other clinical trial within 30 days prior to screening or simultaneous participation in other clinical trials;
- •Previous participation in this study.
研究组 & 干预措施
Placebo
Placebo Comparator
Subcutaneous injection of mannitol 40 mg, water for injections till 1 ml, every day
干预措施: Placebo (Drug)
BCD-063 (glatiramer acetate)
Experimental
Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day
干预措施: BCD-063 (Drug)
Copaxone-Teva (glatiramer acetate)
Active Comparator
Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day
干预措施: Copaxone-Teva (Drug)
结局指标
主要结局
Cumulative Unique Activity lesions
时间窗: 48 weeks
Cumulative Unique Activity (CUA) detected by MRI
次要结局
- Proportion of patients without relapses(48 weeks)
- Amount of new or extended lesions in T2 regimen(48 weeks)
- Changing in volume of T2 lesions(48 weeks)
- Annual relapse rate(48 weeks)
- T1 lesions amount(48 weeks)
- Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline(48 weeks)
- Risk of relapse(48 weeks)
- Changing in volume of hypointense T1 lesions(48 weeks)
- Patients proportion without lesions(48 weeks)
- Time till the first relapse(48 weeks)
- Expanded Disability Status Scale dynamics(Week 24, Week 48)
- Multiple Sclerosis Functional Composite scale dynamics(24, 48 weeks)
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