Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-10 @ 11:16 AM
Study NCT ID:
NCT02092961
Status:
TERMINATED
Last Update Posted:
2014-06-25
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523665', 'term': 'fostamatinib'}, {'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dave.goldstraw@astrazeneca.com', 'phone': '+44 (0)1625 512415', 'title': 'Dave Goldstraw', 'organization': 'AstraZeneca Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The disclosure restriction on the PI is that the sponsor can review and comment on results communications prior to publication. Sponsor will be allowed a review period of at least 60 days from submission but can request that publication be delayed for a period up to 6 months. Any reasonable comments made by the sponsor will be incorporated by the PI into the publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'description': 'For placebo treated patients time frame includes both placebo(6 weeks) and fostamatinib(18 weeks) treatment. 1 SAE occurred in these treatment arms began during the 6 week placebo treated period', 'eventGroups': [{'id': 'EG000', 'title': 'ADALIMUMAB 40 MG', 'description': 'Dosing Group D', 'otherNumAtRisk': 28, 'otherNumAffected': 7, 'seriousNumAtRisk': 28, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'FOSTA 100 MG BID', 'description': 'Dosing Group A', 'otherNumAtRisk': 33, 'otherNumAffected': 17, 'seriousNumAtRisk': 33, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period', 'otherNumAtRisk': 22, 'otherNumAffected': 7, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period', 'otherNumAtRisk': 29, 'otherNumAffected': 4, 'seriousNumAtRisk': 29, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RHEUMATOID ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'RASH MACULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'FEMORAL NECK FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'POST PROCEDURAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'EXOSTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'ORTHOSTATIC HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG PO BID', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'ADALIMUMAB 40 MG SC', 'description': 'Dosing Group D'}, {'id': 'OG002', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID', 'description': 'Dosing Group E'}], 'classes': [{'title': '6 weeks (n=25, 22, 20)', 'categories': [{'measurements': [{'value': '-1.50', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '0.00'}, {'value': '-0.50', 'groupId': 'OG001', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-0.50', 'upperLimit': '1.63'}]}]}, {'title': '24 weeks (n=18, 16, 18)', 'categories': [{'measurements': [{'value': '-0.25', 'groupId': 'OG000', 'lowerLimit': '-3.00', 'upperLimit': '1.00'}, {'value': '-1.03', 'groupId': 'OG001', 'lowerLimit': '-2.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-2.75', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.75', 'ciLowerLimit': '-2.75', 'ciUpperLimit': '-0.42', 'pValueComment': 'A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.', 'estimateComment': 'The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \\<0 indicates a benefit towards fostamatinib.', 'groupDescription': '6 weeks', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).', 'testedNonInferiority': False}, {'pValue': '0.402', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.50', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '2.00', 'pValueComment': 'A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.', 'estimateComment': 'The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \\<0 indicates a benefit towards fostamatinib.', 'groupDescription': '24 weeks', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': 'OMERACT RAMRIS synovitis score was based on 8 joints, scored from MRI images, and ranged from 0 to 24 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG PO BID', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'ADALIMUMAB 40 MG SC', 'description': 'Dosing Group D'}, {'id': 'OG002', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID', 'description': 'Dosing Group E'}], 'classes': [{'title': '6 weeks (n=25, 22, 20)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.50', 'upperLimit': '0.50'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-1.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-0.50', 'upperLimit': '1.50'}]}]}, {'title': '24 weeks (n=18, 16, 18)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-3.50', 'upperLimit': '6.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-1.67', 'upperLimit': '1.25'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-1.00', 'upperLimit': '2.00'}]}]}], 'analyses': [{'pValue': '0.746', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '0.50', 'pValueComment': 'A negative value for change from baseline in OMERACT RAMRIS osteitis score indicates a better clinical condition.', 'estimateComment': 'The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \\<0 indicates a benefit towards fostamatinib.', 'groupDescription': '6 weeks', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).', 'testedNonInferiority': False}, {'pValue': '0.413', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.00', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '3.50', 'pValueComment': 'A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.', 'estimateComment': 'The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \\<0 indicates a benefit towards fostamatinib.', 'groupDescription': '24 weeks', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': 'OMERACT RAMRIS osteitis score was based on 25 joints, scored from MRI images, and ranged from 0 to 75 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG PO BID', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'ADALIMUMAB 40 MG SC', 'description': 'Dosing Group D'}, {'id': 'OG002', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID', 'description': 'Dosing Group E'}], 'classes': [{'title': '6 weeks (n=25, 22, 20)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}, {'title': '24 weeks (n=18, 16, 18)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '0.491', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.00', 'pValueComment': 'A negative value for change from baseline in JSN score indicates a better clinical condition.', 'estimateComment': 'The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \\<0 indicates a benefit towards fostamatinib.', 'groupDescription': '6 weeks', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).', 'testedNonInferiority': False}, {'pValue': '0.341', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.00', 'pValueComment': 'A negative value for change from baseline in JSN score indicates a better clinical condition.', 'estimateComment': 'The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \\<0 indicates a benefit towards fostamatinib.', 'groupDescription': '24 weeks', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': 'Joint space narrowing score was based on 20 joints, scored from MRI images and ranged from 0 to 80 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, JSN = joint space narrowing, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG PO BID', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'ADALIMUMAB 40 MG SC', 'description': 'Dosing Group D'}, {'id': 'OG002', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID', 'description': 'Dosing Group E'}], 'classes': [{'title': '6 weeks (n=25, 22, 20)', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '0.75'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '1.00'}]}]}, {'title': '24 weeks (n=18, 16, 18)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '3.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.75', 'upperLimit': '0.50'}, {'value': '1.25', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '4.50'}]}]}], 'analyses': [{'pValue': '0.366', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.00', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.00', 'pValueComment': 'A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.', 'estimateComment': 'The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \\<0 indicates a benefit towards fostamatinib.', 'groupDescription': '6 weeks', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).', 'testedNonInferiority': False}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.25', 'ciLowerLimit': '0.50', 'ciUpperLimit': '2.50', 'pValueComment': 'A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.', 'estimateComment': 'The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \\<0 indicates a benefit towards fostamatinib.', 'groupDescription': '24 weeks', 'statisticalMethod': 'Van Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': 'OMERACT RAMRIS erosions score was based on 25 joints and ranged from 0 to 250 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FOSTA 100 MG PO BID', 'description': 'Dosing Group A'}, {'id': 'OG001', 'title': 'ADALIMUMAB 40 MG SC', 'description': 'Dosing Group D'}, {'id': 'OG002', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID', 'description': 'Dosing Group E'}], 'classes': [{'title': '6 weeks (n=32, 27, 27)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.35', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '1.1', 'spread': '1.16', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '0.75'}, {'value': '0.5', 'spread': '1.06', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '1.50'}]}]}, {'title': '24 weeks (n=20, 19, 17)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.61', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '3.00'}, {'value': '1.5', 'spread': '1.44', 'groupId': 'OG001', 'lowerLimit': '-0.75', 'upperLimit': '0.50'}, {'value': '1.6', 'spread': '1.39', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '4.50'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.41', 'groupDescription': 'Change from baseline at Week 6. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.', 'testedNonInferiority': False}, {'pValue': '0.496', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.34', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.49', 'groupDescription': 'Change from baseline at Week 24. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': "DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment in accordance with the intention to treat principle.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FOSTA 100 MG PO BID', 'description': 'Dosing Group A'}, {'id': 'FG001', 'title': 'ADALIMUMAB 40 MG SC', 'description': 'Dosing Group D'}, {'id': 'FG002', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID', 'description': 'Dosing Group E'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients who received treatment', 'groupId': 'FG000', 'numSubjects': '33'}, {'comment': 'Patients who received treatment', 'groupId': 'FG001', 'numSubjects': '28'}, {'comment': 'Patients who received treatment', 'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Randomised But Did Not Receive Treatment', 'achievements': [{'comment': 'Study stopped', 'groupId': 'FG000', 'numSubjects': '1'}, {'comment': 'Eligibility criteria not fulfilled/study stopped', 'groupId': 'FG001', 'numSubjects': '5'}, {'comment': 'Eligibility criteria not fulfilled', 'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of patients who completed treatment includes patients who had a dose reduction.', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Number of patients who completed treatment includes patients who had a dose reduction.', 'groupId': 'FG001', 'numSubjects': '14'}, {'comment': 'Number of patients who completed treatment includes patients who had a dose reduction.', 'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study stopped', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Lack of therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Dev. of study specific discont. criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '198 patients were enrolled: 34, 33 and 30 were randomised to Groups A, D and E (33, 28 and 29 received at least 1 dose of IP). Two of the randomised patients were in the main study (D4300C00004).', 'preAssignmentDetails': 'A total of 101 patients failed screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FOSTA 100 MG PO BID', 'description': 'Dosing Group A'}, {'id': 'BG001', 'title': 'ADALIMUMAB 40 MG SC', 'description': 'Dosing Group D'}, {'id': 'BG002', 'title': 'PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID', 'description': 'Dosing Group E'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '53', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '48', 'spread': '14.7', 'groupId': 'BG002'}, {'value': '51', 'spread': '12.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Indian or Pakistani', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, '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': 198}}, 'statusModule': {'whyStopped': 'AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2014-03-19', 'resultsFirstSubmitDate': '2014-04-25', 'studyFirstSubmitQcDate': '2014-03-19', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-28', 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': 'OMERACT RAMRIS osteitis score was based on 25 joints, scored from MRI images, and ranged from 0 to 75 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.'}, {'measure': 'Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': 'Joint space narrowing score was based on 20 joints, scored from MRI images and ranged from 0 to 80 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, JSN = joint space narrowing, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.'}, {'measure': 'OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': 'OMERACT RAMRIS erosions score was based on 25 joints and ranged from 0 to 250 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.'}, {'measure': 'DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': "DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous."}], 'primaryOutcomes': [{'measure': 'OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)', 'timeFrame': 'Baseline, 6 and 24 weeks', 'description': 'OMERACT RAMRIS synovitis score was based on 8 joints, scored from MRI images, and ranged from 0 to 24 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'OSKIRA', 'fostamatinib', 'CE-MRI', 'DCE-MRI'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a sub-study of the OSKIRA-4 study, (D4300C0004, NCT01264770) to explore alternative and more sensitive modalities for measuring the beneficial effects of syk inhibition with fostamatinib in patients with active RA. This MRI sub-study was reported later than the main study due to recruitment delays at specialist imaging sites and so is registered and presented entirely separately to the main study results.\n\nThis study will investigate the impact of treatment on joint activity and damage by assessing synovitis, osteitis, bone erosions and joint space narrowing.', 'detailedDescription': 'Sub-study to OSKIRA-4: A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study Date: 21 March 2011 Version: 1 Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by: - Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: -\n\n* Male or female aged 18 and over\n* Active rheumatoid arthritis (RA) diagnosed after the age of 16\n* Diagnosis within 5 years prior to study visit 1 and inadequate response to treatment with a maximum 2 Disease-Modifying anti-rheumatic drug (DMARD) therapies, or\n* diagnosis within 5 years prior to study visit 1 and intolerance to DMARD therapy, or\n* diagnosis within 2 years prior to study visit 1 and no previous use of DMARDs\n* 4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)\n* Either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or\n* C-Reactive Protein (CRP) blood result of 10mg/L or more\n* At least 2 of the following:\n\n * documented history or current presence of positive rheumatoid factor (blood test),\n * radiographic erosion within 12 months prior to study enrolment,\n * presence of serum anti-cyclic citrullinated peptide antibodies (blood test)\n * Presence of at least one swollen hand or wrist joint.\n * Presence of synovitis on baseline MRI scan, defined as at least 1 joint with RAMRIS synovitis score of +1 or greater.\n\nExclusion Criteria:\n\n* Females who are pregnant or breast feeding\n* Poorly controlled hypertension\n* Liver disease or significant liver function test abnormalities\n* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders\n* Recent or significant cardiovascular disease\n* Significant active or recent infection including tuberculosis\n* Previously received treatment with a TNF alpha antagonist (including etanercept, certolizumab, adalimumab, infliximab, golimumab) or anakinra or previous treatment with other biological agent including rituximab, abatacept and tocilizumab\n* Use of any DMARDs within 6 weeks before first study visit\n* Severe renal impairment\n* Neutropenia\n* Unable to undergo an MRI examination (e.g. presence of a pacemaker, defibrillator, or other implanted metallic device such as anterior interbody cages, aneurysm clip or pedicle screws)\n* Known allergy to Gadolinium-based contrast agent,\n* Tattoos \\[in area of examination if contains metallic pigment\\]\n* Likely to require sedation for the procedure\n* eGFR less than 55 mL/min'}, 'identificationModule': {'nctId': 'NCT02092961', 'acronym': 'OSKIRA 4 SS', 'briefTitle': 'Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Placebo or Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study', 'orgStudyIdInfo': {'id': 'D4300C00004Sub'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dosing Group A', 'description': 'Oral treatment and subcutaneous injection.', 'interventionNames': ['Drug: Fostamatinib', 'Drug: Placebo of Adalimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dosing Group D', 'description': 'Oral treatment and subcutaneous injection.', 'interventionNames': ['Drug: Adalimumab', 'Drug: Placebo of Fostamatinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dosing Group E', 'description': 'Placebo bid for 6 weeks followed by switch to 100 mg fostamatinib bid for 24 weeks, plus placebo subcutaneous injection every 2 weeks.', 'interventionNames': ['Drug: Fostamatinib', 'Drug: Placebo of Fostamatinib', 'Drug: Placebo of Adalimumab']}], 'interventions': [{'name': 'Fostamatinib', 'type': 'DRUG', 'description': 'Fostamatinib 100mg twice daily.', 'armGroupLabels': ['Dosing Group A', 'Dosing Group E']}, {'name': 'Adalimumab', 'type': 'DRUG', 'description': 'Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks.', 'armGroupLabels': ['Dosing Group D']}, {'name': 'Placebo of Fostamatinib', 'type': 'DRUG', 'description': 'Placebo bid for 6 weeks.', 'armGroupLabels': ['Dosing Group D', 'Dosing Group E']}, {'name': 'Placebo of Adalimumab', 'type': 'DRUG', 'description': 'Placebo injection once every two weeks.', 'armGroupLabels': ['Dosing Group A', 'Dosing Group E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Paradise Valley', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.53115, 'lon': -111.94265}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'city': 'Durban', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Stellenbosch', 'country': 'South Africa', 'facility': 'Research Site', 'geoPoint': {'lat': -33.93462, 'lon': 18.86676}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Neil MacKillop, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}