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

Sponsor

Biocad (Industry)

Overall Status

Completed

CT.gov ID

NCT02753088

Collaborator

(none)

158

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-remitting Multiple Sclerosis	Drug: BCD-063 Drug: Copaxone-Teva Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BCD-063 (glatiramer acetate) Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day	Drug: BCD-063 Other Names: glatiramer acetate
Active Comparator: Copaxone-Teva (glatiramer acetate) Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day	Drug: Copaxone-Teva Other Names: glatiramer acetate
Placebo Comparator: Placebo Subcutaneous injection of mannitol 40 mg, water for injections till 1 ml, every day	Drug: Placebo Other Names: mannitol

Arm

Intervention/Treatment

Experimental: BCD-063 (glatiramer acetate)

Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day

Drug: BCD-063

Other Names:

glatiramer acetate

Active Comparator: Copaxone-Teva (glatiramer acetate)

Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day

Drug: Copaxone-Teva

Other Names:

glatiramer acetate

Placebo Comparator: Placebo

Subcutaneous injection of mannitol 40 mg, water for injections till 1 ml, every day

Drug: Placebo

Other Names:

mannitol

Outcome Measures

Primary Outcome Measures

Cumulative Unique Activity lesions [48 weeks]
Cumulative Unique Activity (CUA) detected by MRI

Secondary Outcome Measures

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]
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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.