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

NCT02753088 | Completed Phase 3

• 1 other identifier: BCD-063-1
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

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

Keywords

Equivalence; BCD-063; Copaxone-Teva

Outcome Measures

Primary Outcomes (1)

• Cumulative Unique Activity lesions

  Cumulative Unique Activity (CUA) detected by MRI

  48 weeks

Secondary Outcomes (12)

• Annual relapse rate

  48 weeks

• Proportion of patients without relapses

  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

Study Arms (3)

BCD-063 (glatiramer acetate)

EXPERIMENTAL

Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day

Drug: BCD-063

Copaxone-Teva (glatiramer acetate)

ACTIVE COMPARATOR

Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day

Drug: Copaxone-Teva

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BCD-063 DRUG

Also known as: glatiramer acetate

BCD-063 (glatiramer acetate)

Copaxone-Teva DRUG

Also known as: glatiramer acetate

Copaxone-Teva (glatiramer acetate)

Placebo DRUG

Also known as: mannitol

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Previously diagnosed multiple sclerosis (MS, McDonald criteria 2005);
• Presence of 1 relapse previously OR at least 1 Gd+ lesion in T1 regimen;
• EDSS 0-5,5;
• Readiness of patients (both genders) to use reliable methods of contraception (at least 1 barrier method in combination with: spermicides, intrauterine device/oral contraceptives)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biocad: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Glatiramer Acetate; Mannitol

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Roman A. Ivanov, PhD

  Biocad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 27, 2016
• Study Start: October 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 16, 2021

Record last verified: 2021-09