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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
BCD-033 (interferon beta 1a)
Rebif (interferon beta 1a)
Placebo
Sponsored by
Biocad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scientific neurology center, RAS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

BCD-033

Rebif

Placebo

Arm Description

Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Annual Relapse Rate
Annual relapse rate ARR for 52 weeks was evaluated in all three groups, after the application of IFN beta-1a
Proportion of Subjects Without Confirmed Relapse
proportion of subjects without confirmed relapse in PP
Relapse Free Time
Time to first relapse in "per protocol" population
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)
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.
Relapse Free Time
Time to first relapse in "per protocol" population
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).

Full Information

First Posted
May 29, 2015
Last Updated
May 18, 2022
Sponsor
Biocad
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1. Study Identification

Unique Protocol Identification Number
NCT02727907
Brief Title
Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2015 (Actual)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
August 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad

4. Oversight

Data Monitoring Committee
No

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCD-033
Arm Type
Experimental
Arm Description
Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks
Arm Title
Rebif
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BCD-033 (interferon beta 1a)
Intervention Description
Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks
Intervention Type
Drug
Intervention Name(s)
Rebif (interferon beta 1a)
Intervention Description
Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks
Primary Outcome Measure Information:
Title
Number of Combined Unique Active Lesions
Description
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).
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Annual Relapse Rate
Description
Annual relapse rate ARR for 52 weeks was evaluated in all three groups, after the application of IFN beta-1a
Time Frame
52 weeks
Title
Proportion of Subjects Without Confirmed Relapse
Description
proportion of subjects without confirmed relapse in PP
Time Frame
16, 52 weeks
Title
Relapse Free Time
Description
Time to first relapse in "per protocol" population
Time Frame
96 weeks
Title
Number of Combined Unique Active Lesions
Description
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)
Time Frame
96 weeks
Title
Annual Relapse Rate
Description
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.
Time Frame
96 week
Title
Relapse Free Time
Description
Time to first relapse in "per protocol" population
Time Frame
16, 52 weeks
Title
Number of Combined Unique Active Lesions
Description
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).
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Adverse Events/Serious Adverse Events
Description
quantity and grade of all AE/SAE is calculated in subjects, who received at least one dose of study drug
Time Frame
96 weeks
Title
Severe Adverse Events Frequency
Description
AE grade 3-4 (CTCAE 4.03) is calculated in subjects, who received at least one dose of study drug
Time Frame
52 weeks
Title
Withdrawal
Description
quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug
Time Frame
16, 52 weeks
Title
Immunogenicity
Description
Count of Participants with Binding and Neutralizing Antibodies
Time Frame
16, 52 weeks
Title
Adverse Reaction/Serious Adverse Reactions
Description
quantity and grade of all adverse reactions/serious adverse reactions is calculated in subjects, who received at least one dose of study drug
Time Frame
16, 52 weeks
Title
Severe Adverse Events Frequency
Description
AE grade 3-4 (CTCAE 4.03)is calculated in subjects, who received at least one dose of study drug
Time Frame
96 weeks
Title
Withdrawal
Description
quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug
Time Frame
96 weeks
Title
Immunogenicity
Description
Count of Participants with Binding and Neutralizing Antibodies
Time Frame
96 weeks
Title
Serious Adverse Events
Description
quantity and grade of all SAE is calculated in subjects, who received at least one dose of study drug
Time Frame
52 week of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-55 Patients of both genders with Multiple Sclerosis (McDonald criteria 2010) No relapses 28 days before randomisation Expanded Disability Status Scale score 0-5,5 Exclusion Criteria Primary or secondary progression of Multiple Sclerosis Expanded Disability Status Scale score more then 5,5 Severe depression, suicide ideas and/or attempts Systemic corticosteroid application in 30 days before randomisation
Facility Information:
Facility Name
Scientific neurology center, RAS
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
https://biocad.ru/we/
Description
Related Info

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

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