Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-28 @ 9:28 AM
Study NCT ID:
NCT01999192
Status:
TERMINATED
Last Update Posted:
2017-08-24
First Post:
2013-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, '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': 'C000629755', 'term': 'tregalizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'xuefei_zhou@biotest.de', 'phone': '+496103801', 'title': 'Xuefei Zhou Manager Strategy & Development', 'phoneExt': '1229', 'organization': 'Biotest AG'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the lack of efficacy the Extension Phase of the study was terminated early.'}}, 'adverseEventsModule': {'timeFrame': 'through study completion, up to 1 year', 'description': 'All adverse events have been matched in accordance with the dosing under which they occurred. This resulted in a higher number of subjects at risk, because some subjects received two dosages. Patients who responded at week 12 continued the same treatment for 12 weeks and non-responders at week 12 were escalated to the next higher dose level or re-randomized to active treatment (placebo patients). After 24 weeks, placebo patients were switched to active treatment during the Extension Phase.', 'eventGroups': [{'id': 'EG000', 'title': '25mg Dose Level 1 Tregalizumab', 'description': 'Dose Level 1 Tregalizumab (25mg)', 'otherNumAtRisk': 105, 'otherNumAffected': 14, 'seriousNumAtRisk': 105, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': '100mg Dose Level 2 Tregalizumab', 'description': 'Dose Level 2 Tregalizumab (100mg)', 'otherNumAtRisk': 117, 'otherNumAffected': 16, 'seriousNumAtRisk': 117, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '200mg Dose Level 3 Tregalizumab', 'description': 'Dose Level 3 Tregalizumab (200mg)', 'otherNumAtRisk': 122, 'otherNumAffected': 15, 'seriousNumAtRisk': 122, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo -', 'otherNumAtRisk': 80, 'otherNumAffected': 9, 'seriousNumAtRisk': 80, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'seriousEvents': [{'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Abdominal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Multiple Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Shock Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Flavivirus Test Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Multiple Sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Frostbite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Generalised Tonic-Clonic Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Lichen Planus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1 Tregalizumab', 'description': '25mg Tregalizumab s.c. weekly'}, {'id': 'OG001', 'title': 'Dose Level 2 Tregalizumab', 'description': '100mg Tregalizumab s.c. weekly'}, {'id': 'OG002', 'title': 'Dose Level 3 Tregalizumab', 'description': '200mg Tregalizumab s.c. weekly'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo s.c. weekly'}], 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000'}, {'value': '47.0', 'groupId': 'OG001'}, {'value': '44.3', 'groupId': 'OG002'}, {'value': '35.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication.\n\nThe analysis of the primary endpoint was performed using observed cases (OC) on the FAS.', 'unitOfMeasure': 'percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.\n\nFull analysis set (FAS): All subjects entered into the study who received at least one dose of study medication and have at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Proportions of Subjects With an ACR 20 Response.', 'timeFrame': 'Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportions of Subjects With an ACR 50 & 70 Response.', 'timeFrame': 'Week 12 & Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportions of Subjects With an Disease Activity Score DAS28 <2.6', 'timeFrame': 'Week 12 & Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportions of Subjects With Low Disease Activity DAS28 ≤3.2', 'timeFrame': 'Week 12 & Week 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'ACR Score', 'timeFrame': 'up to 48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Simple Disease Activity Index [SDAI] ≤11', 'timeFrame': 'week 12 & 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Clinical Disease Activity Index [CDAI] ≤10', 'timeFrame': 'week 12 & 24', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'DAS28', 'timeFrame': 'up to 48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'EULAR Response', 'timeFrame': 'up to 48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'ACR Score Individual Components', 'timeFrame': 'up to 48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'DAS28 Score Individual Components', 'timeFrame': 'up to 48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics', 'timeFrame': 'up to 48 weeks', 'description': 'AUC, Cmax, Tmax at baseline, and at Week (W) 2/Visit (V) 4, W4/V5, W8/V7, W12/V8, W24/V10, W3/V122, W48 (end of Treatment \\[EoT\\]/ early termination ET), and at follow-up (post EoT/post ET).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evaluation of Safety, Patient Reported Outcomes & Blood Tests.', 'timeFrame': 'up to 48 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Level 1 Tregalizumab', 'description': '25mg Tregalizumab s.c. weekly'}, {'id': 'FG001', 'title': 'Dose Level 2 Tregalizumab', 'description': '100mg Tregalizumab s.c. weekly'}, {'id': 'FG002', 'title': 'Dose Level 3 Tregalizumab', 'description': '200mg Tregalizumab s.c. weekly'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo s.c. weekly'}], 'periods': [{'title': 'Main Phase I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '70'}, {'groupId': 'FG003', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}, {'title': 'Main Phase II', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Non-responders were switched to higher dose Level after Main Phase 1, started = completed -switched.', 'groupId': 'FG000', 'numSubjects': '64'}, {'comment': 'started Patient = completed patients + switched patients (non-responder) from other arms.', 'groupId': 'FG001', 'numSubjects': '75'}, {'comment': 'started Patient = completed patients + switched patients (non-responder) from other arms.', 'groupId': 'FG002', 'numSubjects': '98'}, {'comment': 'non-responders were switched to higher dose Level after Main Phase 1, started = completed -switched', 'groupId': 'FG003', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '76'}, {'groupId': 'FG003', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Some patients terminated or were switched to higher dose Level after Main Phase 2.', 'groupId': 'FG000', 'numSubjects': '54'}, {'comment': 'Some patients terminated or were switched to higher dose Level after Main Phase 2.', 'groupId': 'FG001', 'numSubjects': '56'}, {'comment': 'Some patients terminated after Main Phase 2.', 'groupId': 'FG002', 'numSubjects': '68'}, {'comment': 'No Placebo arm for Extension Phase, all patients terminated or were switched to tregalizumab Groups.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '313', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Level 1 Tregalizumab', 'description': '25mg Tregalizumab s.c. weekly'}, {'id': 'BG001', 'title': 'Dose Level 2 Tregalizumab', 'description': '100mg Tregalizumab s.c. weekly'}, {'id': 'BG002', 'title': 'Dose Level 3 Tregalizumab', 'description': '200mg Tregalizumab s.c. weekly'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo s.c. weekly'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '0-<40 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}, {'title': '40-<=65 years', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '8 subjects of 321 who had no post-baseline assessment were excluded from the Full Analysis Set (FAS), (one subject \\[1.3%\\] in the placebo group, three subjects \\[3.6%\\] in Dose Level 1 Tregalizumab group, two subjects \\[2.5%\\] in Dose Level 2 Tregalizumab group, and two subjects \\[2.6%\\] in Dose Level 3 Tregalizumab group).'}}, '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': 321}}, 'statusModule': {'whyStopped': 'Lack of efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2013-11-17', 'resultsFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-25', 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'up to 48 weeks', 'description': 'AUC, Cmax, Tmax at baseline, and at Week (W) 2/Visit (V) 4, W4/V5, W8/V7, W12/V8, W24/V10, W3/V122, W48 (end of Treatment \\[EoT\\]/ early termination ET), and at follow-up (post EoT/post ET).'}, {'measure': 'Evaluation of Safety, Patient Reported Outcomes & Blood Tests.', 'timeFrame': 'up to 48 weeks'}], 'primaryOutcomes': [{'measure': 'The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX', 'timeFrame': 'Week 12', 'description': 'The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication.\n\nThe analysis of the primary endpoint was performed using observed cases (OC) on the FAS.'}], 'secondaryOutcomes': [{'measure': 'Proportions of Subjects With an ACR 20 Response.', 'timeFrame': 'Week 24'}, {'measure': 'Proportions of Subjects With an ACR 50 & 70 Response.', 'timeFrame': 'Week 12 & Week 24'}, {'measure': 'Proportions of Subjects With an Disease Activity Score DAS28 <2.6', 'timeFrame': 'Week 12 & Week 24'}, {'measure': 'Proportions of Subjects With Low Disease Activity DAS28 ≤3.2', 'timeFrame': 'Week 12 & Week 24'}, {'measure': 'ACR Score', 'timeFrame': 'up to 48 weeks'}, {'measure': 'Simple Disease Activity Index [SDAI] ≤11', 'timeFrame': 'week 12 & 24'}, {'measure': 'Clinical Disease Activity Index [CDAI] ≤10', 'timeFrame': 'week 12 & 24'}, {'measure': 'DAS28', 'timeFrame': 'up to 48 weeks'}, {'measure': 'EULAR Response', 'timeFrame': 'up to 48 weeks'}, {'measure': 'ACR Score Individual Components', 'timeFrame': 'up to 48 weeks'}, {'measure': 'DAS28 Score Individual Components', 'timeFrame': 'up to 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inadequate response to MTX', 'Methotrexate', 'rheumatoid Arthritis', 'Phase 2b'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '29343509', 'type': 'DERIVED', 'citation': 'van Vollenhoven RF, Keystone EC, Strand V, Pacheco-Tena C, Vencovsky J, Behrens F, Racewicz A, Zipp D, Rharbaoui F, Wolter R, Knierim L, Schmeidl R, Zhou X, Aigner S, Dalken B, Wartenberg-Demand A; TREAT2b study team. Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial. Ann Rheum Dis. 2018 Apr;77(4):495-499. doi: 10.1136/annrheumdis-2017-212478. Epub 2018 Jan 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone.\n\nThe overall study duration is 24 weeks followed by a 24 week extension phase.', 'detailedDescription': 'The planned clinical study 986 (TREAT 2b) is a 24-week study in patients with Active rheumatoid arthritis (RA) who have had an inadequate response to Methotrexate (MTX) alone. The main phase of this study is followed by a 24-week extension phase for subjects meeting the respective entry criteria. Patients will be randomized to one of three different Active treatment groups or Placebo. The primary efficacy variable is the proportion of subjects with an ACR20 response after 12 weeks of double blinded treatment with the study medication based on observed cases in the FAS.\n\nAt Week 12, all subjects who had a minimum improvement of at least 20% (from baseline) in their tender joint count (TJC) and swollen joint count (SJC) continued on the same treatment. Subjects who had not demonstrated an improvement of at least 20% of TJC and SJC were assessed as non-responders. Non-responders who received placebo were randomized to an active treatment dose in a blinded manner. Non-responders who received active treatment were rolled up to the next highest dose in a blinded manner, apart from those already on the highest dose. These subjects remained on the highest dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject demonstrates active RA according to the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA with functional class I-III for ≥6 months.\n2. Subject receives oral or parenteral MTX treatment for ≥12 weeks (overall), with an unchanged mode of application and stable MTX dose of ≥15 mg per week (or ≥12.5 mg per week in case of MTX intolerance), but no more than the highest locally approved dose for RA, for ≥8 weeks prior to baseline. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons. If applicable, the dose of folic acid must be unchanged for ≥8 weeks prior to baseline.\n3. Subject meets the following two criteria at both screening and baseline: - At least 6 swollen joints at 28-joint assessment. - At least 6 tender joints at 28-joint assessment.\n4. Subject has an erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) above the upper limit of normal (ULN) at screening. These tests may be repeated once during the screening period at the discretion of the investigator.\n5. Subject is ≥18 and ≤75 years of age.\n6. Subject has a body mass index ≥18 and ≤35 kg/m².\n7. Subject receives treatment with corticosteroids ≤10 mg prednisone equivalent, stable for at least 4 weeks prior to baseline and during the study, if applicable.\n8. Subject receives treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable for at least 2 weeks prior to baseline and during the study, if applicable.\n9. Female subjects of childbearing potential: has both a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.\n10. Subject is judged to be in good general health as determined by the investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray (within 3 months before screening date is acceptable), and 12-lead electrocardiogram (ECG).\n11. Subject has a cluster of differentiation 4 (CD4) cell count of \\> 400/µl at screening.\n\nExclusion Criteria:\n\n1. Subject has previous exposure to any systemic biologic therapy (e.g., etanercept, adalimumab, rituximab, abatacept, tocilizumab), to Janus kinase (JAK) or spleen tyrosine kinase (SYK) inhibitors, or to Tregalizumab. Previous treatment with an anti-TNF agent is allowed only, if all of the following criteria apply: - treatment was stopped for reasons other than lack of efficacy or adverse events (AEs) - treatment was stopped at least 12 weeks or five half-lives of the compound prior to baseline (whichever is longer), and - the treatment period did not exceed 6 weeks.\n2. Subject received treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs) apart from MTX in the 12 weeks prior to baseline, and for DMARD leflunomide in the 24 weeks prior to baseline (except where specific leflunomide wash-out procedures were completed, following applicable guidelines).\n3. Subject has been treated with intra-articular or parenteral administration of corticosteroids in the 4 weeks prior to baseline. Inhaled corticosteroids for stable medical conditions are allowed.\n4. Subject has undergone joint surgery in the 12 weeks prior to baseline (at joints to be assessed within the study) or has undergone major surgery (e.g., abdominal surgery) in the 8 weeks prior to baseline.\n5. Subject has a history of acute inflammatory joint disease of an origin other than RA or subject has any other rheumatic disease other than RA (e.g., mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, fibromyalgia, systemic lupus erythematosus or any arthritis with onset prior to age 17 years). However, subjects may have secondary Sjögren's syndrome."}, 'identificationModule': {'nctId': 'NCT01999192', 'acronym': '986', 'briefTitle': 'Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotest'}, 'officialTitle': 'A 24-week Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Tregalizumab (BT061) in Combination With Methotrexate in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Alone, Followed by a 24-week Extension Phase: T Cell REgulating Arthritis Trial 2b (TREAT 2b)', 'orgStudyIdInfo': {'id': '986_TREAT 2b'}, 'secondaryIdInfos': [{'id': '2013-000114-38', 'type': 'EUDRACT_NUMBER'}, {'id': 'BT986', 'type': 'OTHER', 'domain': 'Biotest AG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1 Tregalizumab', 'description': '25mg Tregalizumab s.c. weekly', 'interventionNames': ['Drug: Tregalizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 2 Tregalizumab', 'description': '100mg Tregalizumab s.c. weekly', 'interventionNames': ['Drug: Tregalizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 3 Tregalizumab', 'description': '200mg Tregalizumab s.c. weekly', 'interventionNames': ['Drug: Tregalizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo s.c. weekly', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tregalizumab', 'type': 'DRUG', 'otherNames': ['BT061'], 'description': 'humanized anti-CD4 mAb', 'armGroupLabels': ['Dose Level 1 Tregalizumab', 'Dose Level 2 Tregalizumab', 'Dose Level 3 Tregalizumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'identical end formulation buffer', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85253', 'city': 'Paradise Valley', 'state': 'Arizona', 'country': 'United States', 'facility': 'Study Site 07', 'geoPoint': {'lat': 33.53115, 'lon': -111.94265}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Study Site 01', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Study Site 03', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '07012', 'city': 'Clifton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Study Site 02', 'geoPoint': {'lat': 40.85843, 'lon': -74.16376}}, {'zip': '29406', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Study Site 04', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Study Site 05', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Study Site 09', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77450', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Study Site 10', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Study Site 01', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Study Site 06', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Study Site 02', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Study Site 04', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Study Site 07', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Study Site 05', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Study Site 03', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Study Site 02', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'city': 'Saint-Jérôme', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Study Site 01', 'geoPoint': {'lat': 45.78036, 'lon': -74.00365}}, {'city': 'Bruntál', 'country': 'Czechia', 'facility': 'Study Site 03', 'geoPoint': {'lat': 49.98844, 'lon': 17.4647}}, {'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Study Site 05', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Study Site 01', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Study Site 04', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Study Site 08', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Study Site 09', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Uherské Hradiště', 'country': 'Czechia', 'facility': 'Study Site 02', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'city': 'Uherské Hradiště', 'country': 'Czechia', 'facility': 'Study Site 07', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'city': 'Zlín', 'country': 'Czechia', 'facility': 'Study Site 06', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Study Site 01', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Study Site 03', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Study Site 04', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'München', 'country': 'Germany', 'facility': 'Study Site 06', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Ratingen', 'country': 'Germany', 'facility': 'Study Site 02', 'geoPoint': {'lat': 51.29724, 'lon': 6.84929}}, {'city': 'Zerbst', 'country': 'Germany', 'facility': 'Study Site 01', 'geoPoint': {'lat': 51.9662, 'lon': 12.08517}}, {'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Study Site 03', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Study Site 02', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Study Site 04', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Study Site 05', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Gyula', 'country': 'Hungary', 'facility': 'Study Site 06', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'city': 'Veszprém', 'country': 'Hungary', 'facility': 'Study Site 01', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Study Site 01', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Study Site 02', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'Study Site 06', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}, {'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Study Site 05', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Study Site 08', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Chihuahua City', 'country': 'Mexico', 'facility': 'Study Site 02', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'city': 'Distrito Federal', 'country': 'Mexico', 'facility': 'Study Site 03', 'geoPoint': {'lat': 16.59, 'lon': -93.02694}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': 'Study Site 08', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Study Site 05', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Elblag', 'country': 'Poland', 'facility': 'Study Site 10', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'city': 'Gdynia', 'country': 'Poland', 'facility': 'Study Site 04', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Study Site 02', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Study Site 03', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Study Site 06', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Study Site 09', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Study Site 01', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Study Site 07', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Study Site 08', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Study Site 11', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'city': 'Kursk', 'country': 'Russia', 'facility': 'Study Site 04', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Study Site 03', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Study Site 07', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Study Site 10', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Omsk', 'country': 'Russia', 'facility': 'Study Site 05', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'city': 'Saratov', 'country': 'Russia', 'facility': 'Study Site 09', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'city': 'Smolensk', 'country': 'Russia', 'facility': 'Study Site 06', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'Tomsk', 'country': 'Russia', 'facility': 'Study Site 01', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Study Site 02', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Study Site 01', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Study Site 02', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Study Site 04', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Niška Banja', 'country': 'Serbia', 'facility': 'Study Site 03', 'geoPoint': {'lat': 43.29507, 'lon': 22.0057}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Study Site 03', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Kosice - Saca', 'country': 'Slovakia', 'facility': 'Study Site 04'}, {'city': 'Lučenec', 'country': 'Slovakia', 'facility': 'Study Site 05', 'geoPoint': {'lat': 48.33249, 'lon': 19.66708}}, {'city': 'Považská Bystrica', 'country': 'Slovakia', 'facility': 'Study Site 02', 'geoPoint': {'lat': 49.12153, 'lon': 18.42169}}, {'city': 'Rimavská Sobota', 'country': 'Slovakia', 'facility': 'Study Site 01', 'geoPoint': {'lat': 48.38284, 'lon': 20.02239}}, {'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Study Site 08', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Study Site 01', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Study Site 02', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Study Site 03', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Study Site 04', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Study Site 05', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Study Site 06', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Study Site 07', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Study Site 09', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}], 'overallOfficials': [{'name': 'Ronald van Vollenhoven, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Universitetssjukhuset, Solna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotest', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}