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

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®.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: BCD-033 (interferon beta 1a); Drug: Rebif (interferon beta 1a); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Scientific neurology center, RAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCD-033; Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks	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
Active Comparator: Rebif; 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	Drug: Rebif (interferon beta 1a); Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
Placebo Comparator: 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	Drug: Placebo; Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Combined Unique Active Lesions	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).	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Relapse Rate	Annual relapse rate ARR for 52 weeks was evaluated in all three groups, after the application of IFN beta-1a	52 weeks
Proportion of Subjects Without Confirmed Relapse	proportion of subjects without confirmed relapse in PP	16, 52 weeks
Relapse Free Time	Time to first relapse in "per protocol" population	96 weeks
Number of Combined Unique Active Lesions	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)	96 weeks
Annual Relapse Rate	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.	96 week
Relapse Free Time	Time to first relapse in "per protocol" population	16, 52 weeks
Number of Combined Unique Active Lesions	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).	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events/Serious Adverse Events	quantity and grade of all AE/SAE is calculated in subjects, who received at least one dose of study drug	96 weeks
Severe Adverse Events Frequency	AE grade 3-4 (CTCAE 4.03) is calculated in subjects, who received at least one dose of study drug	52 weeks
Withdrawal	quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug	16, 52 weeks
Immunogenicity	Count of Participants with Binding and Neutralizing Antibodies	16, 52 weeks
Adverse Reaction/Serious Adverse Reactions	quantity and grade of all adverse reactions/serious adverse reactions is calculated in subjects, who received at least one dose of study drug	16, 52 weeks
Severe Adverse Events Frequency	AE grade 3-4 (CTCAE 4.03)is calculated in subjects, who received at least one dose of study drug	96 weeks
Withdrawal	quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug	96 weeks
Immunogenicity	Count of Participants with Binding and Neutralizing Antibodies	96 weeks
Serious Adverse Events	quantity and grade of all SAE is calculated in subjects, who received at least one dose of study drug	52 week of study

Collaborators and Investigators

• Sponsor: Biocad

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2015
• Primary Completion (Actual): November 21, 2016
• Study Completion (Actual): August 11, 2017

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta
• Other Study ID Numbers: BCD-033-2