Multiple SclerosisPhase 2/3NCT02727907
Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
A Phase 2/3 study testing BCD-033 (interferon beta 1a) and Rebif (interferon beta 1a) in people with Multiple Sclerosis, run by Biocad at 1 site in Russia.
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®. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BCD-033 (interferon beta 1a) and Rebif (interferon beta 1a)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteRussia
- Study dates
- 12 Feb 2015to 11 Aug 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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®.
- Conditions
- Multiple Sclerosis
- Being tested
- BCD-033 (interferon beta 1a), Rebif (interferon beta 1a), Placebo
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks
| Study group | Role | What they receive |
|---|---|---|
| BCD-033 | Experimental | Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks Receives: 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 52 weeks
Secondary outcomes (7)
Annual Relapse Rate
Annual relapse rate ARR for 52 weeks was evaluated in all three groups, after the application of IFN beta-1a
Measured: 52 weeks
Proportion of Subjects Without Confirmed Relapse
proportion of subjects without confirmed relapse in PP
Measured: 16, 52 weeks
Relapse Free Time
Time to first relapse in "per protocol" population
Measured: 96 weeks
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)
Measured: 96 weeks
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.
Measured: 96 week
Relapse Free Time
Time to first relapse in "per protocol" population
Measured: 16, 52 weeks
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).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start12 Feb 2015
- Primary completion21 Nov 2016
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727907
- Sponsor's protocol ID
- BCD-033-2
- Status last verified
- May 2022
- First submitted
- 29 May 2015
- Last updated
- 17 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02727907
- Acronym / sponsor ID
- BCD-033-2
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2015 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Posted 17 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCD-033 | Experimental | 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 | Active comparator | Drug: Rebif (interferon beta 1a)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 |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | BCD-033 |
| Rebif (interferon beta 1a)Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks | Drug | Rebif |
| PlaceboSubcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks | Drug | Placebo |
Primary outcome
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).
7 secondary outcomes
Annual Relapse Rate
Time frame: 52 weeks
Proportion of Subjects Without Confirmed Relapse
Time frame: 16, 52 weeks
Relapse Free Time
Time frame: 96 weeks
Number of Combined Unique Active Lesions
Time frame: 96 weeks
Annual Relapse Rate
Time frame: 96 week
Relapse Free Time
Time frame: 16, 52 weeks
Number of Combined Unique Active Lesions
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BCD-033 (interferon beta 1a) and Rebif (interferon beta 1a) in people with Multiple Sclerosis, run by Biocad at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Combined Unique Active Lesions (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.