Relapsing-remitting Multiple SclerosisPhase 3NCT02753088
Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis
A Phase 3 study testing BCD-063 and Copaxone-Teva in people with Relapsing-remitting Multiple Sclerosis, run by Biocad.
Trial summary
The objective of the clinical study of the medicinal product for medical use: to compare efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- BCD-063 and Copaxone-Teva
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Previously diagnosed multiple sclerosis (MS, McDonald criteria 2005);
- Disease more, than 1 year prior to inclusion;
- Presence of 1 relapse previously OR at least 1 Gd+ lesion in T1 regimen;
- EDSS 0-5,5;
- Absence of exacerbations for 4 weeks prior to inclusion;
- Readiness of patients (both genders) to use reliable methods of contraception (at least 1 barrier method in combination with: spermicides, intrauterine device/oral contraceptives)
Who cannot join
- Secondary progressive and primary progressive forms of multiple sclerosis;
- Other diseases (except multiple sclerosis), which may affect the assessment of the severity of the symptoms of the underlying disease: mask, amplify, modify the symptoms of the underlying disease or cause the clinical manifestations and changes in the data of laboratory and instrumental methods of investigation similar to those of multiple sclerosis;
- Any acute or chronic infection in the acute stage;
- Verified HIV, hepatitis B and C, syphilis;
- Metabolic abnormalities (disorders), which manifest themselves as:
- raising the general level of creatinine is more than 2 times over the upper limit of the normal range;
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- increase in transaminases (ALT, AST) or gamma-glutamyltransferase more than 2.5 times over the upper limit of the normal range;
- Violation of bone marrow function as reducing the total number of leukocytes <3000 /mcl, or a platelet count <125000 /mcl, hemoglobin concentration reduction, or <100 g / l;
- EDSS> 5,5 points;
- Liver disease in the stage of decompensation;
- Congestive heart failure, or not controlled by a drug therapy angina or arrhythmia;
- Pregnancy, breast-feeding or planned pregnancy during the study period;
- Use of any time prior to study any drug for modifying multiple sclerosis: interferon beta-1a, interferon beta-1b, glatiramer acetate, azathioprine, corticosteroids and immunomodulators (except for treating exacerbations corticosteroids), drugs and monoclonal antibodies, cytotoxic and / or immunosuppressive drugs, including, but not limited to drugs: mitoxantrone, cyclophosphamide, cyclosporine, fingolimod, cladribine; or total lymphoid irradiation system;
- System (IV, oral) corticosteroids within 30 days prior to the screening visit;
- Intolerance or allergy to glatiramer acetate, mannitol or other components of the BCD-063 preparations or Copaxone®-Teva;
- History of drug addiction, alcoholism and abuse of drugs;
- Contraindications to MRI (gadolinium allergic to or intolerant of closed spaces, any renal failure, which may interfere with the removal of gadolinium - an acute or chronic renal failure);
- Any malignancies, including in anamnesis;
- Vaccination within 4 weeks prior to study entry (prior to randomization);
- Participation in any other clinical trial within 30 days prior to screening or simultaneous participation in other clinical trials;
- Previous participation in this study.
About this study
Official title: International, Multicentre, Double-blind, Placebo-controlled, Comparative, Randomized Study to Compare Efficacy and Safety of the Generic Drug BCD-063 (CJSC "BIOCAD", Russia) and Copaxone®-Teva ("Teva Pharmaceutical Industries Limited", Israel) in Patients With Relapsing-remitting Multiple Sclerosis
The objective of the clinical study of the medicinal product for medical use: to compare efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis.
Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to March 23, 2016.
Number of patients, involved into the study of the medicinal product for medical use: 158 patients.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- BCD-063, Copaxone-Teva, Placebo
- Keywords
- Equivalence, BCD-063, Copaxone-Teva
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-063Drug
Also called glatiramer acetate
Copaxone-TevaDrug
Also called glatiramer acetate
PlaceboDrug
Also called mannitol
| Study group | Role | What they receive |
|---|---|---|
| BCD-063 (glatiramer acetate) | Experimental | Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day Receives: Drug: BCD-063 |
| Copaxone-Teva (glatiramer acetate) | Active comparator | Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day Receives: Drug: Copaxone-Teva |
| Placebo | Placebo comparator | Subcutaneous injection of mannitol 40 mg, water for injections till 1 ml, every day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Unique Activity lesions
Cumulative Unique Activity (CUA) detected by MRI
Measured: 48 weeks
Secondary outcomes (12)
Annual relapse rate
Relapse per patient per year
Measured: 48 weeks
Proportion of patients without relapses
Proportion of patients without confirming relapses with magnetic resonance imaging (MRI)
Measured: 48 weeks
Changing in volume of hypointense T1 lesions
Measured: 48 weeks
Changing in volume of T2 lesions
Measured: 48 weeks
Amount of new or extended lesions in T2 regimen
Measured: 48 weeks
Patients proportion without lesions
Measured: 48 weeks
T1 lesions amount
Measured: 48 weeks
Expanded Disability Status Scale dynamics
Expanded Disability Status Scale (EDSS) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group
Measured: Week 24, Week 48
Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline
Measured: 48 weeks
Risk of relapse
Relative Risk Ratio for relapse in each group
Measured: 48 weeks
Time till the first relapse
Measured: 48 weeks
Multiple Sclerosis Functional Composite scale dynamics
Multiple Sclerosis Functional Composite (MSFC) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group
Measured: 24, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startOct 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman A. Ivanov, PhD, Study director, Biocad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753088
- Sponsor's protocol ID
- BCD-063-1
- Status last verified
- Sep 2021
- First submitted
- 19 Apr 2016
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicentre, Double-blind, Placebo-controlled, Comparative, Randomized Study to Compare Efficacy and Safety of the Generic Drug BCD-063 (CJSC "BIOCAD", Russia) and Copaxone®-Teva ("Teva Pharmaceutical Industries Limited", Israel) in Patients With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02753088
- Acronym / sponsor ID
- BCD-063-1
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- Equivalence, BCD-063, Copaxone-Teva
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the clinical study of the medicinal product for medical use: to compare efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis.
Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to March 23, 2016.
Number of patients, involved into the study of the medicinal product for medical use: 158 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCD-063 (glatiramer acetate) | Experimental | Drug: BCD-063Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day |
| Copaxone-Teva (glatiramer acetate) | Active comparator | Drug: Copaxone-TevaSubcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous injection of mannitol 40 mg, water for injections till 1 ml, every day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Previously diagnosed multiple sclerosis (MS, McDonald criteria 2005);
- Disease more, than 1 year prior to inclusion;
- Presence of 1 relapse previously OR at least 1 Gd+ lesion in T1 regimen;
- EDSS 0-5,5;
- Absence of exacerbations for 4 weeks prior to inclusion;
Key exclusion criteria (21 listed)
- Secondary progressive and primary progressive forms of multiple sclerosis;
- Other diseases (except multiple sclerosis), which may affect the assessment of the severity of the symptoms of the underlying disease: mask, amplify, modify the symptoms of the underlying disease or cause the clinical manifestations and changes in the data of laboratory and instrumental methods of investigation similar to those of multiple sclerosis;
- Any acute or chronic infection in the acute stage;
- Verified HIV, hepatitis B and C, syphilis;
- Metabolic abnormalities (disorders), which manifest themselves as:
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-063Also: glatiramer acetate | Drug | BCD-063 (glatiramer acetate) |
| Copaxone-TevaAlso: glatiramer acetate | Drug | Copaxone-Teva (glatiramer acetate) |
| PlaceboAlso: mannitol | Drug | Placebo |
Primary outcome
Cumulative Unique Activity lesions
Time frame: 48 weeks
Cumulative Unique Activity (CUA) detected by MRI
12 secondary outcomes
Annual relapse rate
Time frame: 48 weeks
Proportion of patients without relapses
Time frame: 48 weeks
Changing in volume of hypointense T1 lesions
Time frame: 48 weeks
Changing in volume of T2 lesions
Time frame: 48 weeks
Amount of new or extended lesions in T2 regimen
Time frame: 48 weeks
Patients proportion without lesions
Time frame: 48 weeks
T1 lesions amount
Time frame: 48 weeks
Expanded Disability Status Scale dynamics
Time frame: Week 24, Week 48
Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline
Time frame: 48 weeks
Risk of relapse
Time frame: 48 weeks
Time till the first relapse
Time frame: 48 weeks
Multiple Sclerosis Functional Composite scale dynamics
Time frame: 24, 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
Roman A. Ivanov, PhD study director
Biocad
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-063 and Copaxone-Teva in people with Relapsing-remitting Multiple Sclerosis, run by Biocad.
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 6 inclusion and 21 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative Unique Activity lesions (time frame: 48 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 16 Sep 2021.