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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727907
• Other study ID #: BCD-033-2
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 12, 2015
• Est. completion date: August 11, 2017

Study information

• Verified date: May 2022
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 11, 2017
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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
• Rebif (interferon beta 1a)
Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
• Placebo
Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Locations

Country	Name	City	State
Russian Federation	Scientific neurology center, RAS	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Severe Adverse Events Frequency	AE grade 3-4 (CTCAE 4.03) is calculated in subjects, who received at least one dose of study drug	52 weeks
Other	Withdrawal	quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug	16, 52 weeks
Other	Immunogenicity	Count of Participants with Binding and Neutralizing Antibodies	16, 52 weeks
Other	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	16, 52 weeks
Other	Severe Adverse Events Frequency	AE grade 3-4 (CTCAE 4.03)is calculated in subjects, who received at least one dose of study drug	96 weeks
Other	Withdrawal	quantity of withdrawals due to AE/SAE is calculated in subjects, who received at least one dose of study drug	96 weeks
Other	Immunogenicity	Count of Participants with Binding and Neutralizing Antibodies	96 weeks
Other	Serious Adverse Events	quantity and grade of all SAE is calculated in subjects, who received at least one dose of study drug	52 week of study
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-ß1? (BCD-033 and Rebif®) (44 mcg).	52 weeks
Secondary	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
Secondary	Proportion of Subjects Without Confirmed Relapse	proportion of subjects without confirmed relapse in PP	16, 52 weeks
Secondary	Relapse Free Time	Time to first relapse in "per protocol" population	96 weeks
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)	96 weeks
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.	96 week
Secondary	Relapse Free Time	Time to first relapse in "per protocol" population	16, 52 weeks
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).	16 weeks

External Links

•   Related Info