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Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02753088
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Biocad

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: BCD-063 Drug: Copaxone-Teva Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BCD-063 (glatiramer acetate)
Subcutaneous injection of glatiramer acetate BCD-063 subcutaneously every day
Drug: BCD-063
Other Name: glatiramer acetate

Active Comparator: Copaxone-Teva (glatiramer acetate)
Subcutaneous injection of glatiramer acetate Copaxone-Teva subcutaneously every day
Drug: Copaxone-Teva
Other Name: glatiramer acetate

Placebo Comparator: Placebo
Subcutaneous injection of mannitol 40 mg, water for injections till 1 ml, every day
Drug: Placebo
Other Name: mannitol




Primary Outcome Measures :
  1. Cumulative Unique Activity lesions [ Time Frame: 48 weeks ]
    Cumulative Unique Activity (CUA) detected by MRI


Secondary Outcome Measures :
  1. Annual relapse rate [ Time Frame: 48 weeks ]
    Relapse per patient per year

  2. Proportion of patients without relapses [ Time Frame: 48 weeks ]
    Proportion of patients without confirming relapses with magnetic resonance imaging (MRI)

  3. Changing in volume of hypointense T1 lesions [ Time Frame: 48 weeks ]
  4. Changing in volume of T2 lesions [ Time Frame: 48 weeks ]
  5. Amount of new or extended lesions in T2 regimen [ Time Frame: 48 weeks ]
  6. Patients proportion without lesions [ Time Frame: 48 weeks ]
  7. T1 lesions amount [ Time Frame: 48 weeks ]
  8. Expanded Disability Status Scale dynamics [ Time Frame: Week 24, Week 48 ]
    Expanded Disability Status Scale (EDSS) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group

  9. Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline [ Time Frame: 48 weeks ]
  10. Risk of relapse [ Time Frame: 48 weeks ]
    Relative Risk Ratio for relapse in each group

  11. Time till the first relapse [ Time Frame: 48 weeks ]
  12. Multiple Sclerosis Functional Composite scale dynamics [ Time Frame: 24, 48 weeks ]
    Multiple Sclerosis Functional Composite (MSFC) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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:

    1. raising the general level of creatinine is more than 2 times over the upper limit of the normal range;
    2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753088


Sponsors and Collaborators
Biocad
Investigators
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Study Director: Roman A. Ivanov, PhD Biocad

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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02753088     History of Changes
Other Study ID Numbers: BCD-063-1
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Biocad:
Equivalence
BCD-063
Copaxone-Teva
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Mannitol
(T,G)-A-L
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Antirheumatic Agents