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

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Rebif (interferon beta 1a); Drug: Placebo; Drug: BCD-033 (interferon beta 1a)

• Registration Number: NCT02727907
• Lead Sponsor: Biocad

Brief 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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Primary Completion: 2016-11-21
• Study Completion: 2017-08-11
• Results First Submitted: 2018-08-03
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-18
• Last Update Submitted: 2022-05-18
• Results First Posted: 2023-02-17
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

1. Age 18-55
2. Patients of both genders with Multiple Sclerosis (McDonald criteria 2010)
3. No relapses 28 days before randomisation
4. Expanded Disability Status Scale score 0-5,5

Exclusion Criteria

1. Primary or secondary progression of Multiple Sclerosis
2. Expanded Disability Status Scale score more then 5,5
3. Severe depression, suicide ideas and/or attempts
4. Systemic corticosteroid application in 30 days before randomisation

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rebif	Rebif (interferon beta 1a)	Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage
Placebo	Placebo	Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 48 weeks, followed by 72 weeks of open-label BCD-033 usage
BCD-033	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

Primary Outcome Measures

Name	Time	Method
Number of Combined Unique Active Lesions	52 weeks	Number of Combined Unique Active Lesions (CUA) -- the number of new MRI contrast uptake lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice) after 52 weeks blinded application of interferon-β1а (BCD-033 and Rebif®) (44 mcg).

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Without Confirmed Relapse	16, 52 weeks	proportion of subjects without confirmed relapse in PP
Annual Relapse Rate	96 week	Annual Relapse Rate ARR for 96 weeks was evaluated in two groups, after the administraion of IFN beta-1a in a full dose for 96 weeks.
Number of Combined Unique Active Lesions	16 weeks	CUA (the number of new contrast-enhanced lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice).
Relapse Free Time	16, 52 weeks	Time to first relapse in "per protocol" population

Trial Locations

Locations (1)

Scientific neurology center, RAS; 🇷🇺 Moscow, Russian Federation