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

NCT ID: NCT02753088

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-11-30

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.

Conditions

Relapsing-remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BCD-063 (glatiramer acetate)

Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day

Group Type: EXPERIMENTAL

BCD-063

Intervention Type: DRUG

Copaxone-Teva (glatiramer acetate)

Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day

Group Type: ACTIVE_COMPARATOR

Copaxone-Teva

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BCD-063

Intervention Type: DRUG

Copaxone-Teva

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

glatiramer acetate; glatiramer acetate; mannitol

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman A. Ivanov, PhD

Role: STUDY_DIRECTOR

Biocad

Other Identifiers

BCD-063-1

Identifier Type: -

Identifier Source: org_study_id