Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis

Treatment tested

• Glatiramer acetate

  Unknown

Compared with

• Glatiramer acetate

  Unknown

Placebo or sham

• Placebo

Other measures (12)

Inclusion Criteria: * 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) Exclusion Criteria: * 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: 1. raising the general level of creatinine is more than 2 times over the upper limit of the normal range; 2. 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.

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.