NCT02727907

Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis

International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years. Study hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original drug Rebif®.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	BCD-033 (interferon beta 1a)	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks
DRUG	Rebif (interferon beta 1a)	Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
DRUG	Placebo	Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Timeline

• Start date: 2015-02-12
• Primary completion: 2016-11-21
• Completion: 2017-08-11
• First posted: 2016-04-05
• Last updated: 2023-02-17
• Results posted: 2023-02-17

Locations

1 site across 1 country: Russia