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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
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* Drug: BCD-063
* Drug: Copaxone-Teva
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCD-063 (glatiramer acetate)<br>Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day | Drug: BCD-063<br> <br> * Other names: glatiramer acetate;|
| Active Comparator: Copaxone-Teva (glatiramer acetate)<br>Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day | Drug: Copaxone-Teva<br> <br> * Other names: glatiramer acetate;|
| Placebo Comparator: Placebo<br>Subcutaneous injection of mannitol 40 mg, water for injections till 1 ml, every day | Drug: Placebo<br> <br> * Other names: mannitol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Unique Activity lesions | Cumulative Unique Activity (CUA) detected by MRI | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual relapse rate | Relapse per patient per year | 48 weeks | 
| Proportion of patients without relapses | Proportion of patients without confirming relapses with magnetic resonance imaging (MRI) | 48 weeks | 
| Changing in volume of hypointense T1 lesions |  | 48 weeks | 
| Changing in volume of T2 lesions |  | 48 weeks | 
| Amount of new or extended lesions in T2 regimen |  | 48 weeks | 
| Patients proportion without lesions |  | 48 weeks | 
| T1 lesions amount |  | 48 weeks | 
| Expanded Disability Status Scale dynamics | Expanded Disability Status Scale (EDSS) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group | Week 24, Week 48 | 
| Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline |  | 48 weeks | 
| Risk of relapse | Relative Risk Ratio for relapse in each group | 48 weeks | 
| Time till the first relapse |  | 48 weeks | 
| Multiple Sclerosis Functional Composite scale dynamics | Multiple Sclerosis Functional Composite (MSFC) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group | 24, 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Equivalence, BCD-063, Copaxone-Teva