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

Biocad

Status and phase: Completed; Phase 3

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: BCD-063; Drug: Placebo; Drug: Copaxone-Teva

Study type: Interventional

Funder types: Industry

Identifiers

NCT02753088

BCD-063-1

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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:

  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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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158 participants in 3 patient groups, including a placebo group

BCD-063 (glatiramer acetate)

Experimental group

Description:

Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day

Treatment:

Drug: BCD-063

Copaxone-Teva (glatiramer acetate)

Active Comparator group

Description:

Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day

Treatment:

Drug: Copaxone-Teva

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo