Ignite Creation Date:
2025-12-24 @ 7:31 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT02359903
Status:
COMPLETED
Last Update Posted:
2016-06-08
First Post:
2015-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'C000706147', 'term': 'BCD-055'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'biryulin@biocad.ru', 'phone': '+7812380 49 33', 'title': 'Biryulin Andrey', 'phoneExt': '925', 'organization': 'BIOCAD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BCD-055 Group', 'description': 'BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha', 'otherNumAtRisk': 45, 'otherNumAffected': 4, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Remicade Group', 'description': 'Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (Remicade)', 'otherNumAtRisk': 45, 'otherNumAffected': 4, 'seriousNumAtRisk': 45, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-055 Group', 'description': 'BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha'}, {'id': 'OG001', 'title': 'Remicade Group', 'description': 'Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (Remicade)'}], 'classes': [{'categories': [{'measurements': [{'value': '26282582', 'groupId': 'OG000', 'lowerLimit': '21094742', 'upperLimit': '32296361'}, {'value': '25914888', 'groupId': 'OG001', 'lowerLimit': '20105020', 'upperLimit': '32661812'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'unitOfMeasure': '(ng/ml)*hour', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BCD-055 Group', 'description': 'BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha'}, {'id': 'OG001', 'title': 'Remicade Group', 'description': 'Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (Remicade)'}], 'classes': [{'categories': [{'measurements': [{'value': '174638', 'groupId': 'OG000', 'lowerLimit': '139415', 'upperLimit': '239141'}, {'value': '195434', 'groupId': 'OG001', 'lowerLimit': '134622', 'upperLimit': '257656'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': 'Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade', 'timeFrame': '2 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade', 'timeFrame': '28 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade', 'timeFrame': '28 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade', 'timeFrame': '28 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade', 'timeFrame': '2 weeks / 28 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Average Concentration of Infliximab at Steady State Phase', 'timeFrame': '28 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Each Group Achieving ASAS20', 'timeFrame': '14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Each Group Achieving ASAS40', 'timeFrame': '14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of BASDAI Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of BASMI Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of BASFI Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of MASES Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of SF36 Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change of Chest Expansion Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade', 'timeFrame': '2 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Total Frequency of AE/SAE Within the Whole Time of the Study', 'timeFrame': '30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study', 'timeFrame': '30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected', 'timeFrame': 'screening / 14 weeks / 30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Early Withdrawal Due to AE/SAE', 'timeFrame': '30 weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maximum Concentration at Steady State', 'timeFrame': '28 weeks', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2016-12'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under the Plasma Concentration-time Curve at Steady State Phase', 'timeFrame': '28 weeks', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2016-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BCD-055 Group', 'description': 'BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha'}, {'id': 'FG001', 'title': 'Remicade Group', 'description': 'Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (Remicade)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BCD-055 Group', 'description': 'BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha'}, {'id': 'BG001', 'title': 'Remicade Group', 'description': 'Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22\n\nInfliximab (Remicade)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '51'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '55'}, {'value': '38', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '53'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All patients who received at least 1 injection of study drug'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-03', 'studyFirstSubmitDate': '2015-01-30', 'resultsFirstSubmitDate': '2016-04-03', 'studyFirstSubmitQcDate': '2015-02-05', 'lastUpdatePostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-03', 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum Concentration at Steady State', 'timeFrame': '28 weeks'}, {'measure': 'Area Under the Plasma Concentration-time Curve at Steady State Phase', 'timeFrame': '28 weeks'}], 'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade', 'timeFrame': '2 weeks', 'description': 'Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.'}, {'measure': 'Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade', 'timeFrame': '2 weeks'}, {'measure': 'Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade', 'timeFrame': '28 weeks'}, {'measure': 'Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade', 'timeFrame': '28 weeks'}, {'measure': 'Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade', 'timeFrame': '28 weeks'}, {'measure': 'Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade', 'timeFrame': '2 weeks / 28 weeks'}, {'measure': 'Average Concentration of Infliximab at Steady State Phase', 'timeFrame': '28 weeks'}, {'measure': 'Percentage of Patients in Each Group Achieving ASAS20', 'timeFrame': '14 weeks / 30 weeks'}, {'measure': 'Percentage of Patients in Each Group Achieving ASAS40', 'timeFrame': '14 weeks / 30 weeks'}, {'measure': 'Mean Change of BASDAI Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks'}, {'measure': 'Mean Change of BASMI Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks'}, {'measure': 'Mean Change of BASFI Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks'}, {'measure': 'Mean Change of MASES Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks'}, {'measure': 'Mean Change of SF36 Score Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks'}, {'measure': 'Mean Change of Chest Expansion Compared With Baseline', 'timeFrame': '14 weeks / 30 weeks'}, {'measure': 'Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade', 'timeFrame': '2 weeks'}, {'measure': 'Total Frequency of AE/SAE Within the Whole Time of the Study', 'timeFrame': '30 weeks'}, {'measure': 'Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study', 'timeFrame': '30 weeks'}, {'measure': 'Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected', 'timeFrame': 'screening / 14 weeks / 30 weeks'}, {'measure': 'Frequency of Early Withdrawal Due to AE/SAE', 'timeFrame': '30 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.', 'detailedDescription': 'ASART-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured by JSC BIOCAD, Russia.The aim of this study is to establish that BCD-055 is equivalent to Remicade in terms of pharmacokinetics and safety when used by the standard regimen in patients with ankylosing spondylitis (AS).\n\nThe study will enroll 90 patients with active AS, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-055 IV at a dose 5 mg/kg on week 0, 2, 6, 14 and 22; patients from the second group will receive Remicade at the same regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent\n* active ankylosing spondylitis, which exists in patient within last 3 months\n* BASDAI score \\> or equal to 4 points, spinal pain (by VAS) \\> or equal to 4 points\n* history of NSAID use for the treatment of AS within last 3 months\n* adequate renal and liver function\n* absence of severe abnormalities in complete blood count\n* consent to use adequate contraception\n* ability to follow Protocol procedures\n\nExclusion Criteria:\n\n* previously use of any biologic for AS treatment\n* total ankylosing of the spine\n* known allergy to chimeric proteins or any excipients of BCD-055/Remicade\n* hepatitis B, active hepatitis C, HIV, syphilis\n* known tuberculosis\n* latent forms of tuberculosis\n* any bacterial infection diagnosed within last month which required oral antibiotics (within last 2 weeks) or parenteral antibiotics (within last 4 weeks)\n* drug or alcohol abuse\n* any other disease which can affect assessments or masking some symptoms of AS (severe osteoarthrosis, nervous disorders with impairment of sensory or motor functions, another inflammatory joint disease apart from AS, etc.)\n* severe uncontrolled hypertension\n* chronic heart failure\n* decompensated renal or liver disorders\n* severe uncontrolled diabetes mellitus\n* chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis\n* any mental disorder, incl. severe depression or/and suicide thoughts/actions in anamnesis\n* unstable angina pectoris\n* myocardial infarction within last 12 months\n\nOther exclusion criteria could be found in the Full Study Protocol'}, 'identificationModule': {'nctId': 'NCT02359903', 'briefTitle': 'Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': 'International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'BCD-055-1/ASART-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCD-055 group', 'description': 'BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22', 'interventionNames': ['Drug: Infliximab (BCD-055)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remicade group', 'description': 'Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22', 'interventionNames': ['Drug: Infliximab (Remicade)']}], 'interventions': [{'name': 'Infliximab (BCD-055)', 'type': 'DRUG', 'otherNames': ['Remicade', 'BCD-055'], 'description': 'infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha', 'armGroupLabels': ['BCD-055 group']}, {'name': 'Infliximab (Remicade)', 'type': 'DRUG', 'armGroupLabels': ['Remicade group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Vitebsk Regional Clinical Hospital', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Chelyabinsk Regional Clinical hospital', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Institute of Rheumotology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'N.Novgorod', 'country': 'Russia', 'facility': 'Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko'}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'North-Western State Medical University n.a. I.I.Mechnikov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Smolensk', 'country': 'Russia', 'facility': 'Local hospital at the station Smolensk OAO RZD', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}], 'overallOfficials': [{'name': 'Ivanov Roman, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'JCS BIOCAD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}