drugset / Trial / NCT02753088

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

NCT02753088

Phase 3 Completed 158 enrolled Biocad
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-10
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Glatiramer Acetate Small molecule Subcutaneous