efficacy and safety of bcd-063 and copaxone-teva in patients with relapsing-remitting multiple sclerosis

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: 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.


Eligibility criteria:
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.

Keywords: equivalence bcd-063 copaxone-teva