Phase 3
Completed N=163
Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
Source: ClinicalTrials.gov NCT02727907 ↗Enrolled (actual)
163
Serious AEs
1.2%
Results posted
Feb 2023
Primary outcomePrimary: Number of Combined Unique Active Lesions — 0.0; 0.0 lesions
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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®.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Combined Unique Active Lesions |
0.0; 0.0; 1.0 | — |
| SECONDARY Annual Relapse Rate |
0.208; 0.145 | — |
| SECONDARY Proportion of Subjects Without Confirmed Relapse |
49; 46; 45; 41; 44; 39 | — |
| SECONDARY Relapse Free Time |
33.5; 14.0; 15.0; 193.0; 123.5; 74.0 | — |
| SECONDARY Number of Combined Unique Active Lesions |
0.0; 0.0; 1.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02727907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.