Relapsing-remitting Multiple Sclerosis
Conditions
Keywords
Equivalence, BCD-063, Copaxone-Teva
Brief 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.
Interventions
DRUGBCD-063
DRUGCopaxone-Teva
DRUGPlacebo
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Unique Activity lesions | 48 weeks | Cumulative Unique Activity (CUA) detected by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients proportion without lesions | 48 weeks | — |
| T1 lesions amount | 48 weeks | — |
| Annual relapse rate | 48 weeks | Relapse per patient per year |
| Proportion of patients without relapses | 48 weeks | Proportion of patients without confirming relapses with magnetic resonance imaging (MRI) |
| Changing in volume of hypointense T1 lesions | 48 weeks | — |
| Amount of new or extended lesions in T2 regimen | 48 weeks | — |
| Expanded Disability Status Scale dynamics | Week 24, Week 48 | Expanded Disability Status Scale (EDSS) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group |
| Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline | 48 weeks | — |
| Risk of relapse | 48 weeks | Relative Risk Ratio for relapse in each group |
| Time till the first relapse | 48 weeks | — |
| Multiple Sclerosis Functional Composite scale dynamics | 24, 48 weeks | Multiple Sclerosis Functional Composite (MSFC) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group |
| Changing in volume of T2 lesions | 48 weeks | — |
Outcome results
None listed