Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-29 @ 3:33 AM
Study NCT ID:
NCT05460832
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2022-07-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IST-06@istesso.co.uk', 'phone': '+44 (0) 207 444 0066', 'title': 'Chief Scientific Officer', 'organization': 'Modern Biosciences'}, 'certainAgreement': {'otherDetails': 'Clinical Trial Agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, a period of 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: Oral capsule', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 4, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MBS2320 5 mg', 'description': 'MBS2320 5 mg: Oral capsule', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 16, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MBS2320 20 mg', 'description': 'MBS2320 20 mg: Oral capsule', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 8, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MBS2320 40 mg', 'description': 'MBS2320 40 mg: Oral capsule', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 13, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving a Successful Composite Clinical Response According to the Criteria for American College of Rheumatology 20% Response (ACR20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Oral capsule'}, {'id': 'OG001', 'title': 'MBS2320 5 mg', 'description': 'MBS2320 5 mg: Oral capsule'}, {'id': 'OG002', 'title': 'MBS2320 20 mg', 'description': 'MBS2320 20 mg: Oral capsule'}, {'id': 'OG003', 'title': 'MBS2320 40 mg', 'description': 'MBS2320 40 mg: Oral capsule'}], 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '49.2', 'groupId': 'OG001'}, {'value': '42.4', 'groupId': 'OG002'}, {'value': '57.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "Achieving clinical response according to the criteria for ACR20:\n\n* ≥20% improvement in 68-Tender Joint Count;\n* ≥20% improvement in 66-SJC; and\n* ≥20% improvement in at least 3 of the 5 following parameters:\n\n 1. Physician's global assessment of disease activity\n 2. Participant's global assessment of disease activity\n 3. Participant's assessment of arthritis pain\n 4. Health Assessment Questionnaire - Disability Index (HAQ-DI)\n 5. High-sensitivity C-reactive protein (hsCRP)", 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of MBS2320', 'timeFrame': 'Week 12', 'description': 'Incidence of all grade adverse events', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: Oral capsule'}, {'id': 'FG001', 'title': 'MBS2320 5 mg', 'description': 'MBS2320 5 mg: Oral capsule'}, {'id': 'FG002', 'title': 'MBS2320 20 mg', 'description': 'MBS2320 20 mg: Oral capsule'}, {'id': 'FG003', 'title': 'MBS2320 40 mg', 'description': 'MBS2320 40 mg: Oral capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '248', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MBS2320 5 mg', 'description': 'MBS2320 5 mg once daily for 12 weeks'}, {'id': 'BG001', 'title': 'MBS2320 20 mg', 'description': 'MBS2320 20 mg once daily for 12 weeks'}, {'id': 'BG002', 'title': 'MBS2320 40 mg', 'description': 'MBS2320 40 mg once daily for 12 weeks'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Matching placebo capsules were provided containing the same excipients as the MBS2320 capsules but minus the active drug. The dosing instructions were the same as for MBS2320.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '209', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'spread': '13.82', 'groupId': 'BG000'}, {'value': '55.0', 'spread': '12.48', 'groupId': 'BG001'}, {'value': '53.0', 'spread': '11.26', 'groupId': 'BG002'}, {'value': '55.5', 'spread': '11.42', 'groupId': 'BG003'}, {'value': '55.0', 'spread': '12.28', 'groupId': 'BG004'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '213', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-12', 'size': 451319, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-27T06:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2022-07-12', 'resultsFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-07', 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Successful Composite Clinical Response According to the Criteria for American College of Rheumatology 20% Response (ACR20)', 'timeFrame': 'Week 12', 'description': "Achieving clinical response according to the criteria for ACR20:\n\n* ≥20% improvement in 68-Tender Joint Count;\n* ≥20% improvement in 66-SJC; and\n* ≥20% improvement in at least 3 of the 5 following parameters:\n\n 1. Physician's global assessment of disease activity\n 2. Participant's global assessment of disease activity\n 3. Participant's assessment of arthritis pain\n 4. Health Assessment Questionnaire - Disability Index (HAQ-DI)\n 5. High-sensitivity C-reactive protein (hsCRP)"}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability of MBS2320', 'timeFrame': 'Week 12', 'description': 'Incidence of all grade adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis (RA)', 'MBS2320'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don\'t respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage. The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate.\n\nApproximately 224 participants with moderate to severe active RA who have not responded to treatment with Methotrexate will be enrolled from around 45 to 55 sites around the world. Participants will be randomly assigned to receive 1 of 3 doses of MBS2320 (5 mg, 20 mg, or 40 mg) or placebo (a "dummy" drug).\n\nThe maximum duration of study participation for a participant will be 22 weeks, which consists of a Screening Period of up to 4 weeks, Treatment Period of 12 weeks, and a Follow-up Period of 6 weeks.\n\nParticipants on the study will be asked to attend the hospital or clinic for regular visits during which they will have planned study assessments to evaluate the effectiveness, tolerability and safety of the study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed with RA based on either the 1987-revised ACR classification criteria or the 2010 ACR/ EULAR criteria for ≥3 months prior to screening.\n2. Has active RA as defined by the following minimum disease activity criteria:\n\n * ≥6 swollen joints (based on 66 joint counts)\n * ≥6 tender joints (based on 68 joint counts)\n * hsCRP \\> upper limit of normal reference range (ULN)\n3. Considered to be inadequately responding to oral or parenteral MTX therapy for ≥3 months and \\<10 years prior to screening and to be tolerating a dose of 15 to 25 mg per week. Participants should also be on a stable dose of folic acid (or equivalent).\n4. Except for MTX, must have discontinued all oral DMARDs prior to baseline visit.\n5. If participants are taking NSAIDs or acetaminophen for stable medical conditions, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit and the doses of the medications should be kept stable throughout the study.\n6. If participants are taking oral corticosteroids (equivalent to prednisolone ≤10 mg), or inhaled corticosteroids, they should be receiving these medications at a stable dose for at least 4 weeks prior to baseline visit for stable medical conditions.\n\nThis list contains only key inclusion criteria.\n\nExclusion Criteria:\n\n1. Abnormality in the 12-lead ECG, heart rate or blood pressure at screening.\n2. Any clinically significant neurological, GI, renal, hepatic, CV, psychiatric, respiratory, metabolic, endocrine, haematological, ophthalmic, or other major disorder which, in the opinion of the Investigator, would put the participant at risk by participating in the study.\n3. Any current malignancy or a history of malignancy within 5 years prior to screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.\n4. Any other inflammatory or arthritic disease in addition to RA that may interfere with the study.\n5. Active infection that is clinically significant in the Investigator's opinion, or any infection requiring hospitalisation or treatment with intravenous antimicrobials ≤60 days of screening, or any infection requiring oral antimicrobial therapy ≤2 weeks of the baseline visit.\n6. Clinically significant features of arthroses that could interfer with study assessments and objectives.\n\nThis list contains only key exclusion criteria."}, 'identificationModule': {'nctId': 'NCT05460832', 'briefTitle': 'Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Modern Biosciences Ltd'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Study to Investigate the Efficacy & Safety of MBS2320 in Participants With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response to Methotrexate Alone', 'orgStudyIdInfo': {'id': 'IST-06'}, 'secondaryIdInfos': [{'id': '2020-005496-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MBS2320 5 mg', 'interventionNames': ['Drug: MBS2320 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'MBS2320 20 mg', 'interventionNames': ['Drug: MBS2320 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'MBS2320 40 mg', 'interventionNames': ['Drug: MBS2320 40 mg']}], 'interventions': [{'name': 'MBS2320 5 mg', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['MBS2320 5 mg']}, {'name': 'MBS2320 20 mg', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['MBS2320 20 mg']}, {'name': 'MBS2320 40 mg', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['MBS2320 40 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banja Luka', 'country': 'Bosnia and Herzegovina', 'facility': 'Site 1201 - Univerzitetski Klinicki Centar Republike Srpske', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'city': 'Banja Luka', 'country': 'Bosnia and Herzegovina', 'facility': 'Site 1204 - Univerzitetski Klinicki Centar Republike Srpske', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'city': 'Gradiška', 'country': 'Bosnia and Herzegovina', 'facility': 'Site 1202 - General Hospital Gradiška', 'geoPoint': {'lat': 45.14484, 'lon': 17.25453}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Site 1308 - Medical Center Medconsult Pleven OOD', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Site 1302 - Medical Center Artmed OOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site 1303 - Diagnostic and Consulting Center Aleksandrovska EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site 1306 - Diagnostic- Consultative Center Convex EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site 1307 - 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