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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 September 2021
• Main ID: NCT02753088
• Date of registration: 19/04/2016
• Prospective Registration: No
• Primary sponsor: Biocad
• Public title: Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis
• Scientific 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
• Date of first enrolment: October 2013
• Target sample size: 158
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02753088
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Contacts

• Name: Roman A. Ivanov, PhD
• Affiliation: Biocad

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis

Intervention(s)

Drug: BCD-063

Drug: Copaxone-Teva

Drug: Placebo

Primary Outcome(s)

Cumulative Unique Activity lesions [Time Frame: 48 weeks]

Secondary Outcome(s)

Risk of relapse [Time Frame: 48 weeks]

Changing in volume of hypointense T1 lesions [Time Frame: 48 weeks]

Expanded Disability Status Scale dynamics [Time Frame: Week 24, Week 48]

Patients proportion without lesions [Time Frame: 48 weeks]

Changing in volume of T2 lesions [Time Frame: 48 weeks]

Proportion of patients without relapses [Time Frame: 48 weeks]

Amount of new or extended lesions in T2 regimen [Time Frame: 48 weeks]

Annual relapse rate [Time Frame: 48 weeks]

Multiple Sclerosis Functional Composite scale dynamics [Time Frame: 24, 48 weeks]

Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline [Time Frame: 48 weeks]

Time till the first relapse [Time Frame: 48 weeks]

T1 lesions amount [Time Frame: 48 weeks]

Secondary ID(s)

BCD-063-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors