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

NCT02753088 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2021-09-16

No results posted yet for this study

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

Interventions

DRUG

BCD-063

DRUG

Copaxone-Teva

DRUG

Placebo

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Roman A. Ivanov, PhD · Biocad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-11-30
Completion
2015-11-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753088 on ClinicalTrials.gov