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

Relapsing-remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753088
• Other study ID #: BCD-063-1
• Status: Completed
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: November 2015

Study information

• Verified date: September 2021
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• BCD-063

• Copaxone-Teva

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Unique Activity lesions	Cumulative Unique Activity (CUA) detected by MRI	48 weeks
Secondary	Annual relapse rate	Relapse per patient per year	48 weeks
Secondary	Proportion of patients without relapses	Proportion of patients without confirming relapses with magnetic resonance imaging (MRI)	48 weeks
Secondary	Changing in volume of hypointense T1 lesions		48 weeks
Secondary	Changing in volume of T2 lesions		48 weeks
Secondary	Amount of new or extended lesions in T2 regimen		48 weeks
Secondary	Patients proportion without lesions		48 weeks
Secondary	T1 lesions amount		48 weeks
Secondary	Expanded Disability Status Scale dynamics	Expanded Disability Status Scale (EDSS) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group	Week 24, Week 48
Secondary	Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline		48 weeks
Secondary	Risk of relapse	Relative Risk Ratio for relapse in each group	48 weeks
Secondary	Time till the first relapse		48 weeks
Secondary	Multiple Sclerosis Functional Composite scale dynamics	Multiple Sclerosis Functional Composite (MSFC) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group	24, 48 weeks