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Completed

NCT Number: NCT02727907

Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With 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®.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Scientific neurology center, RAS

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Rebif (interferon beta 1a)

Drug

Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

Placebo

Drug

Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Primary outcomes

  1. Number of Combined Unique Active Lesions

    Time frame: 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 outcomes

  1. Annual Relapse Rate

    Time frame: 52 weeks

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

  2. Proportion of Subjects Without Confirmed Relapse

    Time frame: 16, 52 weeks

    proportion of subjects without confirmed relapse in PP

  3. Relapse Free Time

    Time frame: 96 weeks

    Time to first relapse in "per protocol" population

  4. Number of Combined Unique Active Lesions

    Time frame: 96 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)

  5. Annual Relapse Rate

    Time frame: 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.

  6. Relapse Free Time

    Time frame: 16, 52 weeks

    Time to first relapse in "per protocol" population

  7. Number of Combined Unique Active Lesions

    Time frame: 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).

Other outcomes

  1. Adverse Events/Serious Adverse Events

    Time frame: 96 weeks

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

  2. Severe Adverse Events Frequency

    Time frame: 52 weeks

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

  3. Withdrawal

    Time frame: 16, 52 weeks

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

  4. Immunogenicity

    Time frame: 16, 52 weeks

    Count of Participants with Binding and Neutralizing Antibodies

  5. Adverse Reaction/Serious Adverse Reactions

    Time frame: 16, 52 weeks

    quantity and grade of all adverse reactions/serious adverse reactions is calculated in subjects, who received at least one dose of study drug

  6. Severe Adverse Events Frequency

    Time frame: 96 weeks

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

  7. Withdrawal

    Time frame: 96 weeks

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

  8. Immunogenicity

    Time frame: 96 weeks

    Count of Participants with Binding and Neutralizing Antibodies

  9. Serious Adverse Events

    Time frame: 52 week of study

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

Sponsors and collaborators

Lead sponsor

Biocad

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 5, 2016
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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