Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-21 @ 9:32 AM
Study NCT ID:
NCT02760368
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2016-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592400', 'term': 'olokizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lemak@rpharm.ru', 'phone': '0074959567937', 'title': 'Maria Lemak, Scientific Advisor', 'phoneExt': '1408', 'organization': 'R-Pharm'}, 'certainAgreement': {'otherDetails': 'Any study related information could be made public available only after Sponsors written permission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from the signature of the informed consent form until the last visit of the subject in the study (up to 22 weeks after the final dose of study treatment) regardless of relationship to study treatment. Any SAE with a start date after the Safety Follow-Up Period was not required to be reported unless the Investigator thought that the event might be related to either the study treatment, study treatment administration, or a protocol procedure.', 'description': 'All AEs and SAEs reported below are related to the Safety Population (safety population included all subjects who receive at least 1 dose of study treatment).\n\nData for TEAEs were reported below. A Treatment Emergent Adverse Event (TEAE) is defined as an AE that first occurred or worsened in severity after the first dose of the study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Olokizumab q4w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q4w + Placebo + Methotrexate (oral)\n\nOlokizumab 64 mg Subcutaneous once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.) + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 53, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Arm 2: Olokizumab q2w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)\n\n64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 51, 'seriousNumAtRisk': 143, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Arm 3: Placebo q2w + Methotrexate', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)\n\nPlacebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 35, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 44, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 32, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Toxic shock syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cervix carcinoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetic vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 142, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Olokizumab q4w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q4w + Placebo + Methotrexate (oral)\n\nOlokizumab 64 mg subcutaneous once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.) + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG001', 'title': 'Arm 2: Olokizumab q2w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)\n\n64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG002', 'title': 'Arm 3: Placebo q2w + Methotrexate', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)\n\nPlacebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.378', 'ciLowerLimit': '0.248', 'ciUpperLimit': '0.489', 'groupDescription': 'The OKZ ACR20 response rates for 64 q2w treatment group at Week 12 are expected to be at least 55%, resulting in an expected difference in ACR20 response rates of 30 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '2x2 chi-square test'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.445', 'ciLowerLimit': '0.318', 'ciUpperLimit': '0.552', 'groupDescription': 'The OKZ ACR20 response rates for 64 q4w treatment group at Week 12 are expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 25 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '2x2 chi-square test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Week 12', 'description': 'A responder was defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12.\n\nThe calculations were based on a ≥ 20% improvement from baseline in the swollen joint count (SJC) assessed in 66 joints and in the tender joint count (TJC) assessed in 68 joints; and a ≥ 20% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (Visual Analog Scale (VAS) assessment), Patient Assessment of Pain (VAS assessment), Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician Global Assessment (VAS assessment), Level of acute phase reactant (CRP or ESR, using level of CRP in this study).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: The ITT population includes all randomized subjects. Subjects were analyzed according to the treatment group to which they were randomized. The ITT population is the primary analysis population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Low Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Olokizumab q4w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q4w + Placebo + Methotrexate (oral)\n\nOlokizumab 64 mg subcutaneous once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.) + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG001', 'title': 'Arm 2: Olokizumab q2w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)\n\n64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG002', 'title': 'Arm 3: Placebo q2w + Methotrexate', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)\n\nPlacebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥ 10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.294', 'ciLowerLimit': '0.197', 'ciUpperLimit': '0.389', 'groupDescription': 'DAS28 low disease activity (based on DAS28 \\[CRP\\] \\<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 30% in 64 q2w OKZ treatment groups respectively, resulting in an expected difference of 20 percentage points between OKZ q2w treatment group and placebo.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '2x2 chi-square test'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.352', 'ciLowerLimit': '0.251', 'ciUpperLimit': '0.449', 'groupDescription': 'DAS28 low disease activity (based on DAS28 \\[CRP\\] \\<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 22% in 64 mg q4w OKZ treatment group respectively, resulting in an expected difference of 12 percentage points between OKZ q4w treatment group and placebo.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '2x2 chi-square test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Week 12', 'description': 'Defined as Disease Activity Score 28 (DAS28) (CRP) \\< 3.2, and remaining on randomized treatment and in the study at Week 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: The ITT population includes all randomized subjects. Subjects were analyzed according to the treatment group to which they were randomized. The ITT population is the primary analysis population.'}, {'type': 'SECONDARY', 'title': 'Improvement of Physical Ability From Baseline to Week 12, as Measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Olokizumab q4w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q4w + Placebo + Methotrexate (oral)\n\nOlokizumab 64 mg subcutaneous once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.) + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG001', 'title': 'Arm 2: Olokizumab q2w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)\n\n64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG002', 'title': 'Arm 3: Placebo q2w + Methotrexate', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)\n\nPlacebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '0.044', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.34', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '-0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.059', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.36', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.059', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change of physical ability from baseline (the last available assessment prior to the first dose of the study treatment) to week 12, as measured by HAQ-DI. The HAQ-DI total score ranges from 0 (the best outcome) to 3 (the worst outcome).The HAQ-DI assesses the degree of difficulty experienced in 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, common daily activities) of daily living activities using 20 questions. Each domain consists of 2 or 3 items. For each question the level of difficulty is scored from 0 (without any difficulty, the best outcome) to 3 (unable to do, the worst outcome). Each category is given a score by taking the maximum score of each question. The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. If fewer than 6 categories had responses, no disability score was calculated.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: The ITT population includes all randomized subjects. Subjects were analyzed according to the treatment group to which they were randomized. The ITT population is the primary analysis population. Subjects with a missing baseline are not included. Data after treatment discontinuation are Included, Data after discontinuing study are multiply Imputed based on the return to baseline assumption.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Olokizumab q4w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q4w + Placebo + Methotrexate (oral)\n\nOlokizumab 64 mg Subcutaneous once every 4 weeks+placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.) + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, Subcutaneous, or intramuscular)'}, {'id': 'OG001', 'title': 'Arm 2: Olokizumab q2w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)\n\n64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG002', 'title': 'Arm 3: Placebo q2w + Methotrexate', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)\n\nPlacebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.350', 'ciLowerLimit': '0.239', 'ciUpperLimit': '0.450', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '2x2 chi-square test'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.409', 'ciLowerLimit': '0.296', 'ciUpperLimit': '0.509', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': '2x2 chi-square test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Week 24', 'description': 'A responder was defined as any subject satisfying ACR50 criteria and remaining on randomized treatment and in the study at Week 24.\n\nThe calculations were based on a ≥ 50% improvement from baseline in the swollen joint count (SJC) assessed in 66 joints and in the tender joint count (TJC) assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (Visual Analog Scale (VAS) assessment), Patient Assessment of Pain (VAS assessment), Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician Global Assessment (VAS assessment), Level of acute phase reactant (CRP or ESR, using level of CRP in this study).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: The ITT population includes all randomized subjects. Subjects were analyzed according to the treatment group to which they were randomized. The ITT population is the primary analysis population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 (Remission)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Olokizumab q4w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q4w + Placebo + Methotrexate (oral)\n\nOlokizumab 64 mg subcutaneous once every 4 weeks+placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.) + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG001', 'title': 'Arm 2: Olokizumab q2w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)\n\n64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'OG002', 'title': 'Arm 3: Placebo q2w + Methotrexate', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)\n\nPlacebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.084', 'ciLowerLimit': '0.032', 'ciUpperLimit': '0.151', 'pValueComment': '2x2 chi-square test', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.077', 'ciLowerLimit': '0.027', 'ciUpperLimit': '0.143', 'pValueComment': '2x2 chi-square test', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Week 24', 'description': 'Percentage of subjects with Clinical Disease Activity Index (CDAI) ≤ 2.8 (remission) and remaining on randomized treatment and in the study at Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: The ITT population includes all randomized subjects. Subjects were analyzed according to the treatment group to which they were randomized. The ITT population is the primary analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Olokizumab q4w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q4w + placebo + Methotrexate (oral)\n\n64 mg Olokizumab administered subcutaneously once every 4 weeks + placebo in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)+concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'FG001', 'title': 'Arm 2: Olokizumab q2w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)\n\n64 mg Olokizumab administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}, {'id': 'FG002', 'title': 'Arm 3: Placebo + Methotrexate', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)\n\nPlacebo administered subcutaneously once every 2 weeks + concomitant background therapy (Methotrexate) at a stable dose of 15 to 25 mg/week (or ≥10 mg/week if there is documented intolerance to higher doses) with a stable route of administration (oral, subcutaneous, or intramuscular)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '143'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Enrollment was conducted at 42 clinical sites (in Belarus, Bulgaria, Russia,Turkey) between May 2016 and April 2018. 785 patients were included, 357 patients screen-failed, 428 patients were randomized (143 patients in OKZ q2w +MTX group, 142 patients in OKZ q4w +MTX group, 143 patients in Placebo q2w +MTX group). 1 subject was randomized by mistake and didn't receive the study treatment. The primary efficacy analysis set included 428 subjects, and the safety analysis set included 427 subjects."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Olokizumab q4w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q4w +placebo q4w+ Methotrexate (oral)\n\nOlokizumab q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial + placebo (sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules)'}, {'id': 'BG001', 'title': 'Arm 2: Olokizumab q2w + Methotrexate', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)\n\nOlokizumab q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial'}, {'id': 'BG002', 'title': 'Arm 3: Placebo q2w + Methotrexate', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)\n\nPlacebo q2w: sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '49.1', 'spread': '12.07', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '11.77', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '11.29', 'groupId': 'BG002'}, {'value': '51.3', 'spread': '11.79', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '354', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '427', 'groupId': 'BG003'}]}, {'title': 'Other/Mixed', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Bulgaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '381', 'groupId': 'BG003'}]}]}, {'title': 'Belarus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '427', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26.40', 'groupId': 'BG000', 'lowerLimit': '14.88', 'upperLimit': '46.23'}, {'value': '26.62', 'groupId': 'BG001', 'lowerLimit': '16.98', 'upperLimit': '45.52'}, {'value': '26.93', 'groupId': 'BG002', 'lowerLimit': '17.46', 'upperLimit': '51.56'}, {'value': '26.65', 'groupId': 'BG003', 'lowerLimit': '14.88', 'upperLimit': '51.56'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': '1 subject had been mistakenly randomized to the placebo group and was discontinued immediately prior to investigational product administration. Therefore, the patient was included in the ITT population by definition, but no other data except baseline demographics (age, gender, race, ethnicity, and region of inclusion) were collected.'}, {'title': 'Baseline Disease Severity', 'classes': [{'title': 'Inactive (DAS28 (CRP) ≤ 3.2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Moderately Active (DAS28 (CRP) > 3.2 to ≤ 5.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}, {'title': 'Very Active (DAS28 (CRP) > 5.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '428', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '363', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The DAS28 (CRP) was calculated using the Swollen joint count (SJC) (28 joints), Tender joint count (TJC) (28 joints), CRP level, and the Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) (100 mm VAS, where 0 is "no disease activity" and 100 was "maximal disease activity") according to the following formula: \\[0.56 × square root of TJC\\] + \\[0.28 × square root of SJC\\] + \\[0.36 × natural log (CRP+1)\\] + \\[0.014 × VAS\\] + 0.96.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-30', 'size': 1887599, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-29T04:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2016-04-29', 'resultsFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response', 'timeFrame': 'at Week 12', 'description': 'A responder was defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12.\n\nThe calculations were based on a ≥ 20% improvement from baseline in the swollen joint count (SJC) assessed in 66 joints and in the tender joint count (TJC) assessed in 68 joints; and a ≥ 20% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (Visual Analog Scale (VAS) assessment), Patient Assessment of Pain (VAS assessment), Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician Global Assessment (VAS assessment), Level of acute phase reactant (CRP or ESR, using level of CRP in this study).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Achieving Low Disease Activity', 'timeFrame': 'at Week 12', 'description': 'Defined as Disease Activity Score 28 (DAS28) (CRP) \\< 3.2, and remaining on randomized treatment and in the study at Week 12.'}, {'measure': 'Improvement of Physical Ability From Baseline to Week 12, as Measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'Baseline to Week 12', 'description': 'Change of physical ability from baseline (the last available assessment prior to the first dose of the study treatment) to week 12, as measured by HAQ-DI. The HAQ-DI total score ranges from 0 (the best outcome) to 3 (the worst outcome).The HAQ-DI assesses the degree of difficulty experienced in 8 domains (dressing and grooming, arising, eating, walking, hygiene, reach, grip, common daily activities) of daily living activities using 20 questions. Each domain consists of 2 or 3 items. For each question the level of difficulty is scored from 0 (without any difficulty, the best outcome) to 3 (unable to do, the worst outcome). Each category is given a score by taking the maximum score of each question. The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. If fewer than 6 categories had responses, no disability score was calculated.'}, {'measure': 'Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response', 'timeFrame': 'at Week 24', 'description': 'A responder was defined as any subject satisfying ACR50 criteria and remaining on randomized treatment and in the study at Week 24.\n\nThe calculations were based on a ≥ 50% improvement from baseline in the swollen joint count (SJC) assessed in 66 joints and in the tender joint count (TJC) assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures: Patient Global Assessment of Disease Activity (Visual Analog Scale (VAS) assessment), Patient Assessment of Pain (VAS assessment), Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician Global Assessment (VAS assessment), Level of acute phase reactant (CRP or ESR, using level of CRP in this study).'}, {'measure': 'Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 (Remission)', 'timeFrame': 'at Week 24', 'description': 'Percentage of subjects with Clinical Disease Activity Index (CDAI) ≤ 2.8 (remission) and remaining on randomized treatment and in the study at Week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['moderate Rheumatoid Arthritis', 'severe Rheumatoid Arthritis', 'subcutaneous', 'Olokizumab'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '34344706', 'type': 'DERIVED', 'citation': 'Nasonov E, Fatenejad S, Feist E, Ivanova M, Korneva E, Krechikova DG, Maslyanskiy AL, Samsonov M, Stoilov R, Zonova EV, Genovese M. Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study. Ann Rheum Dis. 2022 Apr;81(4):469-479. doi: 10.1136/annrheumdis-2021-219876. Epub 2021 Aug 3.'}], 'seeAlsoLinks': [{'url': 'http://acrabstracts.org/abstract/safety-and-efficacy-of-olokizumab-in-a-phase-iii-trial-of-patients-with-moderately-to-severely-active-rheumatoid-arthritis-inadequately-controlled-by-methotrexate-credo1-study/', 'label': 'Nasonov E, Fatenejad S, Korneva E, Krechikova D. - Safety and Efficacy of Olokizumab in a Phase III Trial of Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate - CREDO1 Study \\[abstract\\].'}, {'url': 'http://scientific.sparx-ip.net/archiveeular/?c=a&searchfor=olokizumab&view=1&item=2020OP0021', 'label': 'E. Nasonov, R. Stoilov, T. Tyabut, M. C. Genovese. 2020 OP0021 Olokizumab, Monoclonal Antibody Against IL6, in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate:Results of Phase III CREDO-1 study'}, {'url': 'http://scientific.sparx-ip.net/archiveeular/?c=a&searchfor=olokizumab&view=1&item=2020THU0176', 'label': 'E. Nasonov, M. Ivanova, M. Samsonov, T. Tyabut, M. C. Genovese; 2020 THU0176 Olokizumab Improves Patient Reported Outcomes in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate: Results CREDO-1 study'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with methotrexate (MTX).\n\nThe primary objective of this study was to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active rheumatoid arthritis (RA) inadequately controlled by methotrexate (MTX) therapy.', 'detailedDescription': 'The goal of this Phase III study was to assess the efficacy, tolerability, and safety of OKZ in subjects with moderately to severely active RA who had responded inadequately to MTX. The primary endpoint of the trial was at Week 12. Olokizumab was expected to reduce the disease activity and improve physical function. The study was expected to provide safety information in a large group of subjects over at least a 24 week period.\n\nThe CREDO 1 study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety Follow-Up Period from Week 24 to Week 44.\n\nAt randomization, a total of 428 eligible subjects were randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio:\n\n1. OKZ 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo OKZ q4w to maintain blinding) + MTX.\n2. OKZ 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX.\n3. Placebo: SC injection of placebo q2w + MTX\n\nThroughout the double-blind Treatment Period, all subjects were required to remain on a stable dose of background MTX at 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses) with a stable route of administration, and concomitant treatment with folic acid ≥5 mg per week or equivalent is required for all subjects. The last dose of study treatment (OKZ or placebo) was at Week 22 in all groups.\n\nFollowing Visit 2 (randomization), subjects returned to the study site at least every other week through Week 24 for response and safety assessments as per the study Schedule of Events.\n\nSubjects were classified in terms of their response to study treatment at Week 14, with non-responders defined as subjects in any treatment group who had not improved by at least 20% in both swollen and tender joint counts (66-68 joint assessment). Starting at or as close as possible to Week 14, non-responders were administered sulfasalazine and/or hydroxychloroquine as rescue medication in addition to the assigned treatment.\n\nAfter completion of the 24-week double-blind Treatment Period, subjects either rolled over into the long-term open-label extension (OLE) study or entered the Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for visits +4, +8, and +22 weeks after the last dose of study treatment.\n\nSubjects who discontinued the randomized treatment prematurely were required to come for the End of Treatment (EoT) Visit 2 weeks after the last study treatment administration and then continued with the scheduled study visits as per the Schedule of Events.\n\nThe study was conducted at approximately 50 sites across 4 countries globally, which included Russia, Belarus, Turkey, and Bulgaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects may be enrolled in the study only if they meet all of the following criteria:\n\n* Subjects willing and able to sign informed consent\n* Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 12 weeks prior to Screening.\n* Inadequate response to treatment with MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or ≥10 mg/week if intolerant to higher doses).\n\n * The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening.\n* Subjects must be willing to take folic acid or equivalent throughout the study\n* Subjects must have moderately to severely active RA disease as defined by all of the following:\n\n * ≥6 tender joints (68 joint count) at Screening and baseline; and\n * ≥6 swollen joints (66 joint count) at Screening and baseline; and\n * CRP above ULN at Screening based on the central laboratory results.\n\nExclusion Criteria:\n\n* Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (e.g., gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus). However, subjects could have secondary Sjogren's syndrome or hypothyroidism\n* Subjects who were Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care)\n* Prior exposure to any licensed or investigational compound directly or indirectly targeting IL-6 or IL-6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase \\[SYK\\] inhibitors)\n* Prior treatment with cell-depleting therapies, including anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, and anti-CD19)\n* Prior use of bDMARDs, with the following exception:\n\n • Subjects who discontinued TNFi therapy due to a reason other than lack of efficacy were allowed to enter the study (TNFi therapy was not to be discontinued to facilitate a subject's participation in the study but should instead have been previously discontinued as part of a subject's medical management of RA). The use of TNFi therapy within the following windows prior to baseline was exclusionary:\n 1. 4 weeks for etanercept\n 2. 8 weeks for infliximab\n 3. 10 weeks for adalimumab, certolizumab, and golimumab\n* Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline\n* Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent), or change in dosage within 2 weeks prior to baseline\n* Prior documented history of no response to hydroxychloroquine and sulfasalazine\n* Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs were not to be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):\n\n 1. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline\n 2. 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours\n 3. 24 weeks for cyclophosphamide\n* Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study\n* Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline\n* Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline\n* Use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline\n* Previous participation in this study (randomized) or another study of OKZ\n* Subjects with acute or chronic viral hepatitis B or C infection as detected by blood tests at Screening (e.g., positive for hepatitis B surface antigen \\[HBsAg\\], total hepatitis B core antibody \\[anti-HBc\\], or hepatitis C virus antibody \\[HCV Ab\\])\n\n a. Subjects who were positive for hepatitis B surface antibody (anti-HBs), but negative for HBsAg and anti-HBc, were eligible\n* Subjects with HIV infection\n* Subjects with:\n\n 1. Suspected or confirmed current active TB disease or a history of active TB disease\n 2. Close contact (i.e., sharing the same household or other enclosed environment, such as a social gathering place, workplace, or facility, for extended periods during the day) with an individual with active TB within 1.5 years prior to Screening.\n* Concurrent malignancy or a history of malignancy within the last 5 years (with the exception of successfully treated carcinoma in situ of the cervix and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to Screening \\[and no more than 3 excised skin cancers within the last 5 years prior to Screening\\])\n* Subjects with any infection requiring oral antibiotic or antiviral therapy in the 2 weeks prior to Screening or at baseline, injectable anti-infective therapy in the last 4 weeks prior to baseline, or serious or recurrent infection with a history of hospitalization in the 6 months prior to baseline\n* Subjects with evidence of disseminated herpes zoster infection, zoster encephalitis, meningitis, or other non-self-limited herpes zoster infections in the 6 months prior to baseline\n* Subjects with planned surgery during the study or surgery ≤4 weeks prior to Screening and from which the subject had not fully recovered, as judged by the Investigator\n* Subjects with diverticulitis or other symptomatic GI conditions that might predispose the subject to perforations, including subjects with a history of such predisposing conditions (e.g., diverticulitis, GI perforation, or ulcerative colitis)\n* Pre-existing central nervous system demyelinating disorders (e.g., multiple sclerosis and optic neuritis)\n* History of chronic alcohol or drug abuse as judged by the Investigator\n* Female subjects who are pregnant, currently lactating, have lactated within the last 12 weeks, or who were planning to become pregnant during the study or within 6 months of last dose of study treatment\n* Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman had experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status \\[e.g., correlative age\\] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels \\>40 mIU/mL and estradiol \\<20 pg/mL) who were not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment;\n* Subjects with a known hypersensitivity to any component of the OKZ drug product, or placebo\n* Subjects with a known hypersensitivity or contraindication to any component of the rescue medication\n* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02760368', 'acronym': 'CREDO 1', 'briefTitle': 'Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Pharm'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy', 'orgStudyIdInfo': {'id': 'CL04041022'}, 'secondaryIdInfos': [{'id': '2014-004719-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Olokizumab q4w', 'description': 'Olokizumab 64 mg Subcutaneous q4w +placebo+ Methotrexate (oral) in order to maintain the blind, subjects randomized to receive OKZ q4w will receive placebo injections at the alternate q4w interval (e.g., Week 2, Week 6, etc.)', 'interventionNames': ['Drug: Olokizumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Olokizumab q2w', 'description': 'Olokizumab 64 mg Subcutaneous q2w + Methotrexate (oral)', 'interventionNames': ['Drug: Olokizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 3: Placebo', 'description': 'Placebo Subcutaneous q2w + Methotrexate (oral)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Olokizumab', 'type': 'DRUG', 'description': '160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial', 'armGroupLabels': ['Arm 1: Olokizumab q4w', 'Arm 2: Olokizumab q2w']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules', 'armGroupLabels': ['Arm 1: Olokizumab q4w', 'Arm 3: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220013', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'City Clinical Hospital #1', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '210037', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Vitebsk Regional Clinical Hospital', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': "DCC 'Sv. Pantaleymon' OOD", 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'UMHAT "Kaspela", EOOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT "Sv. Ivan Rilski", EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1784', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MC "Synexus - Sofia", EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '656050', 'city': 'Barnaul', 'state': 'Altayskiy Kray', 'country': 'Russia', 'facility': 'Regional State Budgetary Healthcare Institution "Barnaul City Hospital #4"', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '650000', 'city': 'Kemerovo', 'state': 'Kemerovo Oblast', 'country': 'Russia', 'facility': 'SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '650066', 'city': 'Kemerovo', 'state': 'Kemerovo Oblast', 'country': 'Russia', 'facility': 'Medical Center LLC "Maksimum Zdoroviya"', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '305007', 'city': 'Kursk', 'state': 'Kursk Oblast', 'country': 'Russia', 'facility': 'Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '190068', 'city': 'Saint Petersburg', 'state': "Leningradskaya Oblast'", 'country': 'Russia', 'facility': 'SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit'}, {'zip': '119435', 'city': 'Moscow', 'state': 'Moscovskaya Oblast', 'country': 'Russia', 'facility': 'FSBEI HE "First Moscow State Medical University n.a. I.M. Sechenov of MoH of Russian Federation", UCH #1', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'state': 'Moscovskaya Oblast', 'country': 'Russia', 'facility': 'FSBEI HE "FMSMU n.a. I.M. Sechenov of MoH of RF", University Hospital #2, Departament of New Drugs Introduction', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'state': 'Moscovskaya Oblast', 'country': 'Russia', 'facility': 'SBEI HPE "First Moscow State Medical University n.a. I.M. Sechenov of MoH of Russian Federation" UCH #3', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '19049', 'city': 'Moscow', 'state': 'Moscovskaya Oblast', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution of Moscow "City Clinical Hospital #1 n.a. Pirogov" Healthcare Departament of Moscow', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '111539', 'city': 'Moscow', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department'}, {'zip': '115093', 'city': 'Moscow', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'SBHI of Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament"'}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'state': 'Nizhny Novgorod Oblast', 'country': 'Russia', 'facility': 'SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630099', 'city': 'Novosibirsk', 'state': 'Novosibirsk Oblast', 'country': 'Russia', 'facility': 'State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1"', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '644024', 'city': 'Omsk', 'state': 'Omsk Oblast', 'country': 'Russia', 'facility': 'LLC "Clinical Diagnostic Center "Ultramed"', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '644111', 'city': 'Omsk', 'state': 'Omsk Oblast', 'country': 'Russia', 'facility': 'Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '185019', 'city': 'Petrozavodsk', 'state': 'Republic of Karelia', 'country': 'Russia', 'facility': 'SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '450005', 'city': 'Ufa', 'state': 'Respublic of Bashkortostan', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov"', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '344022', 'city': 'Rostov-on-Don', 'state': 'Rostov Oblast', 'country': 'Russia', 'facility': 'SBEI HPE "Rostov State Medical University" of Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '410053', 'city': 'Saratov', 'state': 'Saratov Oblast', 'country': 'Russia', 'facility': 'State Healthcare Institution "Regional Clinical Hospital"', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '410054', 'city': 'Saratov', 'state': 'Saratov Oblast', 'country': 'Russia', 'facility': 'SBEI HPE "SSMU n.a. V.I. Razumovsky of MoH of RF", Clinical Hospital n.a. S.R. Mirotvorcev, Therapeutic Departament', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '214025', 'city': 'Smolensk', 'state': 'Smolensk Oblast', 'country': 'Russia', 'facility': 'Non-governmental Healtheare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways"', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '355030', 'city': 'Stavropol', 'state': 'Stavropol Kray', 'country': 'Russia', 'facility': 'SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'zip': '620102', 'city': 'Yekaterinburg', 'state': 'Sverdlovsk Oblast', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital #1"', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '620149', 'city': 'Yekaterinburg', 'state': 'Sverdlovsk Oblast', 'country': 'Russia', 'facility': 'SBEI HPE "Ural State Medical University" of MoH of RF based MBI "Central City Clinical Hospital #6"', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '420064', 'city': "Kazan'", 'state': 'The Republic of Tatarstan', 'country': 'Russia', 'facility': 'State Autonomous Healthcare Institution "Republican Clinical Hospital of Ministry of Health of Tatarstan Republic', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '300053', 'city': 'Tula', 'state': 'Tulskaya Oblast', 'country': 'Russia', 'facility': 'State Healthcare Institution of Tula region "Tula Regional Clinical Hospital"', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'zip': '432063', 'city': 'Ulyanovsk', 'state': 'Ulyanovsk Oblast', 'country': 'Russia', 'facility': 'State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"', 'geoPoint': {'lat': 54.32824, 'lon': 48.38657}}, {'zip': '600023', 'city': 'Vladimir', 'state': 'Vladimirskaya Oblast’', 'country': 'Russia', 'facility': 'SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '150062', 'city': 'Yaroslavl', 'state': 'Yaroslavl Oblast', 'country': 'Russia', 'facility': 'SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '150003', 'city': 'Yaroslavl', 'state': 'Yaroslavsakaya Oblast', 'country': 'Russia', 'facility': 'State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev"', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603005', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'City Clinical Hospital №5 of Nizhny Novgorod', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'Ryazan State Medical University n.a. I.P. Pavlov based on Regional Clinical Cardiology Dispensary', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'SBHI "North-West Federat Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Mikhail Samsonov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'R-Pharm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R-Pharm International, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}, {'name': 'OCT Clinical Trials', 'class': 'OTHER'}, {'name': 'Mene Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}