NCT02727907

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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2017

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

February 17, 2023

Completed
Last Updated

February 17, 2023

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

May 29, 2015

Results QC Date

August 3, 2018

Last Update Submit

May 18, 2022

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 (7)

  • Annual Relapse Rate

    52 weeks

  • Proportion of Subjects Without Confirmed Relapse

    16, 52 weeks

  • Relapse Free Time

    96 weeks

  • Number of Combined Unique Active Lesions

    96 weeks

  • Annual Relapse Rate

    96 week

  • +2 more secondary outcomes

Other Outcomes (9)

  • Adverse Events/Serious Adverse Events

    96 weeks

  • Severe Adverse Events Frequency

    52 weeks

  • Withdrawal

    16, 52 weeks

  • +6 more other outcomes

Study Arms (3)

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

Interventions

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
Rebif (interferon beta 1a)DRUG

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

Rebif
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific neurology center, RAS

Moscow, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

April 5, 2016

Study Start

February 12, 2015

Primary Completion

November 21, 2016

Study Completion

August 11, 2017

Last Updated

February 17, 2023

Results First Posted

February 17, 2023

Record last verified: 2022-05

Locations

RU(1)