NCT02744222

Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple Sclerosis

An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 μg and 240 μg, Versus Avonex® (Biogen Idec Ltd., UK) in Patients With Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 μg and 240 μg, versus Avonex® (Biogen Idec Ltd., UK) in Patients with Relapsing-remitting Multiple Sclerosis

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
BIOLOGICAL	BCD-054 180 mcg	180 mcg intramuscularly once every two weeks
BIOLOGICAL	Avonex®	30 mcg intramuscularly once a week
BIOLOGICAL	BCD-054 240 mcg	240 mcg intramuscularly once every two weeks
OTHER	Placebo	intramuscularly once a week (0,5 ml)

Timeline

• Start date: 2017-08-10
• Primary completion: 2018-11-23
• Completion: 2020-07-06
• First posted: 2016-04-20
• Last updated: 2021-09-08

Locations

1 site across 1 country: Russia