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

Biocad

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: Rebif (interferon beta 1a); Drug: BCD-033 (interferon beta 1a)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02727907

BCD-033-2

Details and patient eligibility

About

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®.

Enrollment: 163 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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163 participants in 3 patient groups, including a placebo group

BCD-033

Experimental group

Description:

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

Treatment:

Drug: BCD-033 (interferon beta 1a)

Rebif

Active Comparator group

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

Treatment:

Drug: Rebif (interferon beta 1a)

Placebo

Placebo Comparator group

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

Treatment:

Drug: Placebo