Study of Efficacy and Safety of Drugs BCD-033 and Rebif f... | NCT02727907

Study of Efficacy and Safety of Drugs BCD-033 and Rebif f... | NCT02727907 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BCD-033	Experimental	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)
Rebif	Active Comparator	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)
Placebo	Placebo Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
BCD-033 (interferon beta 1a)	Drug	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks	BCD-033

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Arm/Group Information

ID	Title	Description
FG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks
FG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
FG002	Placebo/BCD-033	Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00053 subjects FG00156 subjects FG00254 subjects
Recived One Injection of Drug		FG00053 subjects FG00155 subjects FG00254 subjects
COMPLETED		FG00040 subjects FG00143 subjects FG00243 subjects
NOT COMPLETED		FG00013 subjects FG00113 subjects FG00211 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	BCD-033	interferon beta-1a (BCD-033)
BG001	Rebif / BCD-033	interferon beta-1a (Rebif / BCD-033)

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

The primary endpoint was assessed after 52 weeks of use of IFN-β1a (BCD-033 and Rebif) in a full dose (44 μg). In the analysis of the effeciency of MRI indicators included 100 patients

Posted

Median

Inter-Quartile Range

lesions

52 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
nephrotic syndrome	Renal and urinary disorders		Systematic Assessment	The patient had an albuminuria, in connection with which he was hospitalized in a hospital for treatment. It is discharged with improvement of a status. The therapy was abolished.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
headache	General disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Linkova Yuliya	BIOCAD	+7(495)9926628	930	linkova@biocad.ru

Condition Browse Module

ID	Term
D009103	Multiple Sclerosis

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Intervention Browse Module

ID	Term
D000068556	Interferon beta-1a

ID	Term
D016899	Interferon-beta
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines

Secondary

Annual Relapse Rate

Annual relapse rate ARR for 52 weeks was evaluated in all three groups, after the application of IFN beta-1a

Posted

Mean

Standard Deviation

relapses

52 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks
OG001	Rebif / BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo / BCD-033	Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage

Units	Counts
Participants	OG00053 OG00155 OG00255

Title

Denominators

Categories

Title	Measurements
	OG0000.113± 0.375 OG0010.091± 0.348 OG0020.109± 0.369

Secondary

Proportion of Subjects Without Confirmed Relapse

proportion of subjects without confirmed relapse in PP

The analysis was performed in per protocol population at 16 and 52 weeks

Posted

Number

Count of Participants

16, 52 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks
OG001	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo	Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage

Units	Counts
Participants	OG00053 OG00151 OG00251

Title

Denominators

Categories

week 16

- ParticipantsOG00053
- ParticipantsOG00151
- ParticipantsOG00251

Title	Measurements

Secondary

Relapse Free Time

Time to first relapse in "per protocol" population

Posted

Median

Inter-Quartile Range

days

96 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

Units	Counts
Participants	OG00040 OG00145

Title

Denominators

Categories

Title	Measurements
	OG000207.0(52.0 to 276.0) OG001183.0(26.0 to 286.0)

Secondary

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)

Posted

Median

Inter-Quartile Range

lesions

96 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks
OG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

Units	Counts
Participants	OG00044 OG00146

Title

Denominators

Categories

Title	Measurements
	OG0000.0(0.0 to 2.0) OG0010.0(0.0 to 2.0)

Secondary

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.

Posted

Mean

Standard Error

relapses

96 week

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

Units	Counts
Participants	OG00053 OG00155

Title

Denominators

Categories

Title	Measurements
	OG0000.208± 0.532 OG0010.145± 0.524

Secondary

Relapse Free Time

Time to first relapse in "per protocol" population

The analysis was performed in per protocol population at 16 and 52 weeks

Posted

Median

Inter-Quartile Range

days

16, 52 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo/BCD-033	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 Placebo: Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Units	Counts
Participants	OG00053 OG00151 OG00251

Title

Denominators

Categories

week 16

- ParticipantsOG00053
- ParticipantsOG00151
- ParticipantsOG00251

Title	Measurements

Secondary

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).

Posted

Median

Inter-Quartile Range

lesions

16 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks
OG001	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo	Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage

Units	Counts
Participants	OG00053 OG00151 OG00251

Title

Denominators

Categories

Title	Measurements
	OG0000.0(0.0 to 2.0) OG0010.0(0.0 to 1.0) OG0021.0(0.0 to 3.0)

Other Pre-specified

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

Posted

Number

adverse events

96 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

Units	Counts
Participants	OG00053 OG00155

Title

Denominators

Categories

Title	Measurements
	OG000124 OG001110

Other Pre-specified

Severe Adverse Events Frequency

AE grade 3-4 (CTCAE 4.03) is calculated in subjects, who received at least one dose of study drug

Posted

Number

adverse events

52 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo/BCD-033	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 Placebo: Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Units	Counts
Participants	OG00053 OG00155 OG00254

Title

Denominators

Categories

Title	Measurements
	OG0005 OG0014 OG0027

Other Pre-specified

Withdrawal

quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug

Posted

Count of Participants

Participants

16, 52 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks
OG001	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo/BCD-033	Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage

Units	Counts
Participants	OG00053 OG00155 OG00254

Title

Denominators

Categories

week 16

Title	Measurements
	OG0000 OG0011 OG0021

week 52

Other Pre-specified

Immunogenicity

Count of Participants with Binding and Neutralizing Antibodies

Posted

Number

participants

16, 52 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo/BCD-033	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 Placebo: Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Units	Counts
Participants	OG00051 OG00149 OG00253

Title

Denominators

Categories

week 16 : Binding Antibodies

Title	Measurements
	OG0006 OG0015 OG0022

week 16 : Neutralizing Antibodies

Other Pre-specified

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

Posted

Number

adverse events

16, 52 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo/BCD-033	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 Placebo: Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Units	Counts
Participants	OG00053 OG00155 OG00254

Title

Denominators

Categories

week 16

Title	Measurements
	OG00067 OG00159 OG00233

week 52

Other Pre-specified

Severe Adverse Events Frequency

AE grade 3-4 (CTCAE 4.03)is calculated in subjects, who received at least one dose of study drug

Posted

Number

adverse events

96 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

Units	Counts
Participants	OG00053 OG00155

Title

Denominators

Categories

Title	Measurements
	OG0002 OG0013

Other Pre-specified

Withdrawal

quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug

Posted

Count of Participants

Participants

96 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks
OG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

Units	Counts
Participants	OG00053 OG00155

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0011

Other Pre-specified

Immunogenicity

Count of Participants with Binding and Neutralizing Antibodies

Posted

Number

participants

96 weeks

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks 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
OG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

Units	Counts
Participants	OG00051 OG00149

Title

Denominators

Categories

Binding Antibodies

Title	Measurements
	OG00019 OG00114

Neutralizing Antibodies

Title	Measurements
	OG000

Other Pre-specified

Serious Adverse Events

quantity and grade of all SAE is calculated in subjects, who received at least one dose of study drug

Posted

Number

adverse events

52 week of study

ID	Title	Description
OG000	BCD-033	Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks BCD-033 (interferon beta 1a): Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 96 weeks
OG001	Rebif/BCD-033	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 Rebif (interferon beta 1a): Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
OG002	Placebo/BCD-033	Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 16 weeks, followed by 68 weeks of open-label BCD-033 usage

Units	Counts
Participants	OG00053 OG00155 OG00254

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0023