Clinical trial NCT02753088: Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Equivalence
BCD-063
Copaxone-Teva
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2016-04-27
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Cumulative Unique Activity lesions
timeFrame: 48 weeks
Secondary outcomes:
measure: Annual relapse rate
timeFrame: 48 weeks
measure: Proportion of patients without relapses
timeFrame: 48 weeks
measure: Changing in volume of hypointense T1 lesions
timeFrame: 48 weeks
measure: Changing in volume of T2 lesions
timeFrame: 48 weeks
measure: Amount of new or extended lesions in T2 regimen
timeFrame: 48 weeks
measure: Patients proportion without lesions
timeFrame: 48 weeks
measure: T1 lesions amount
timeFrame: 48 weeks
measure: Expanded Disability Status Scale dynamics
timeFrame: Week 24, Week 48
measure: Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline
timeFrame: 48 weeks
measure: Risk of relapse
timeFrame: 48 weeks
measure: Time till the first relapse
timeFrame: 48 weeks
measure: Multiple Sclerosis Functional Composite scale dynamics
timeFrame: 24, 48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Biocad
name: Roman A. Ivanov, PhD
role: STUDY_DIRECTOR
References: