Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00746512
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2008-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, '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': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prednisone 15 mg', 'description': 'Prednisone 15 mg tablets once daily for 15 days', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo 15 mg', 'description': 'Prednisone 15 mg placebo tablets once daily for 15 days', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Prednisone 7.5 mg', 'description': 'Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.', 'otherNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo 7.5 mg', 'description': 'Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.', 'otherNumAtRisk': 9, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vulvovaginal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chronic Obstructive Pumonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ingrowing Nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Synovial Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone 15 mg', 'description': 'Prednisone 15 mg tablets once daily for 15 days'}, {'id': 'OG001', 'title': 'Placebo 15 mg', 'description': 'Prednisone 15 mg placebo tablets once daily for 15 days'}, {'id': 'OG002', 'title': 'Prednisone 7.5 mg', 'description': 'Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.'}, {'id': 'OG003', 'title': 'Placebo 7.5 mg', 'description': 'Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.48', 'spread': '6.44', 'groupId': 'OG000'}, {'value': '10.55', 'spread': '9.54', 'groupId': 'OG001'}, {'value': '8.31', 'spread': '8.66', 'groupId': 'OG002'}, {'value': '9.78', 'spread': '7.28', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '6.52', 'spread': '6.40', 'groupId': 'OG000'}, {'value': '13.37', 'spread': '11.05', 'groupId': 'OG001'}, {'value': '4.44', 'spread': '4.94', 'groupId': 'OG002'}, {'value': '9.15', 'spread': '11.65', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Day 14', 'categories': [{'measurements': [{'value': '-2.96', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '4.62', 'groupId': 'OG001'}, {'value': '-3.88', 'spread': '5.71', 'groupId': 'OG002'}, {'value': '-0.64', 'spread': '9.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.', 'unitOfMeasure': 'pixel count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prednisone 15 mg', 'description': 'Prednisone 15 mg tablets once daily for 15 days'}, {'id': 'OG001', 'title': 'Placebo 15 mg', 'description': 'Prednisone 15 mg placebo tablets once daily for 15 days'}, {'id': 'OG002', 'title': 'Prednisone 7.5 mg', 'description': 'Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.'}, {'id': 'OG003', 'title': 'Placebo 7.5 mg', 'description': 'Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.17', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '1.65', 'groupId': 'OG001'}, {'value': '5.31', 'spread': '1.18', 'groupId': 'OG002'}, {'value': '5.62', 'spread': '1.78', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '3.57', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '5.04', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '4.57', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '5.38', 'spread': '1.60', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Day 14', 'categories': [{'measurements': [{'value': '-1.61', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '-0.74', 'spread': '0.86', 'groupId': 'OG002'}, {'value': '-0.23', 'spread': '0.83', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) \\& swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale \\[VAS\\]), and the CRP (in mg/L measured from lab test). The scoring formula was:\n\nDAS28(CRP) = 0.56\\*SQR(TJC28) + 0.28\\*SQR(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH(VAS) + 0.96.\n\nWhere SQR is square root and ln is natural log.\n\nThe formula produces a score from 0 to 10: \\>5.1 means high disease activity; \\<3.2 means low disease activity, \\<2.6 is generally considered remission.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prednisone 15 mg', 'description': 'Prednisone 15 mg tablets once daily for 15 days'}, {'id': 'FG001', 'title': 'Placebo 15 mg', 'description': 'Prednisone 15 mg placebo tablets once daily for 15 days'}, {'id': 'FG002', 'title': 'Prednisone 7.5 mg', 'description': 'Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.'}, {'id': 'FG003', 'title': 'Placebo 7.5 mg', 'description': 'Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Prednisone 15 mg', 'description': 'Prednisone 15 mg tablets once daily for 15 days'}, {'id': 'BG001', 'title': 'Placebo 15 mg', 'description': 'Prednisone 15 mg placebo tablets once daily for 15 days'}, {'id': 'BG002', 'title': 'Prednisone 7.5 mg', 'description': 'Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.'}, {'id': 'BG003', 'title': 'Placebo 7.5 mg', 'description': 'Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '69'}, {'value': '58.4', 'groupId': 'BG001', 'lowerLimit': '45', 'upperLimit': '86'}, {'value': '57.9', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '81'}, {'value': '55.1', 'groupId': 'BG003', 'lowerLimit': '32', 'upperLimit': '71'}, {'value': '58.1', 'groupId': 'BG004', 'lowerLimit': '32', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2008-09-03', 'resultsFirstSubmitDate': '2010-12-17', 'studyFirstSubmitQcDate': '2008-09-03', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-10', 'studyFirstPostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Synovial Blood Flow', 'timeFrame': 'Baseline and Day 14', 'description': 'Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.'}], 'secondaryOutcomes': [{'measure': 'Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])', 'timeFrame': 'Baseline and Day 14', 'description': 'The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) \\& swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale \\[VAS\\]), and the CRP (in mg/L measured from lab test). The scoring formula was:\n\nDAS28(CRP) = 0.56\\*SQR(TJC28) + 0.28\\*SQR(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH(VAS) + 0.96.\n\nWhere SQR is square root and ln is natural log.\n\nThe formula produces a score from 0 to 10: \\>5.1 means high disease activity; \\<3.2 means low disease activity, \\<2.6 is generally considered remission.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '22972032', 'type': 'RESULT', 'citation': 'Seymour MW, Kelly S, Beals CR, Malice MP, Bolognese JA, Dardzinski BJ, Cheng AS, Cummings CE, Smugar SS, McClinton C, Fox A, Dooley WM, Pitzalis C, Taylor PC. Ultrasound of metacarpophalangeal joints is a sensitive and reliable endpoint for drug therapies in rheumatoid arthritis: results of a randomized, two-center placebo-controlled study. Arthritis Res Ther. 2012 Sep 12;14(5):R198. doi: 10.1186/ar4034.'}]}, 'descriptionModule': {'briefSummary': 'The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is willing to limit alcohol intake to 3 or less beverages per day\n* Patient agrees to use only acetaminophen/paracetamol for breakthrough pain\n\nExclusion Criteria:\n\n* Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery or donated or lost 1 unit of blood in the last 4 weeks\n* Patient has a history of drug or alcohol abuse in the last 2 years\n* Patient has had a vaccine (with a live or attenuated virus) in the last two weeks'}, 'identificationModule': {'nctId': 'NCT00746512', 'briefTitle': 'A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '0000-088'}, 'secondaryIdInfos': [{'id': '2008_531'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prednisone 15 mg', 'description': 'Prednisone 15 mg tablets once daily for 15 days', 'interventionNames': ['Drug: Prednisone 15 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 15 mg', 'description': 'Prednisone 15 mg placebo tablets once daily for 15 days', 'interventionNames': ['Drug: Placebo Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Prednisone 7.5 mg', 'description': 'Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.', 'interventionNames': ['Drug: Prednisone 7.5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 7.5 mg', 'description': 'Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days\n\nAs per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.', 'interventionNames': ['Drug: Placebo Over-Encapsulated Tablets']}], 'interventions': [{'name': 'Prednisone 15 mg', 'type': 'DRUG', 'otherNames': ['Prednisone'], 'description': 'Prednisone 15 mg tablets once daily for 15 days.', 'armGroupLabels': ['Prednisone 15 mg']}, {'name': 'Placebo Tablets', 'type': 'DRUG', 'description': 'Prednisone placebo tablets once daily for 15 days.', 'armGroupLabels': ['Placebo 15 mg']}, {'name': 'Prednisone 7.5 mg', 'type': 'DRUG', 'otherNames': ['Prednisone'], 'description': 'Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days', 'armGroupLabels': ['Prednisone 7.5 mg']}, {'name': 'Placebo Over-Encapsulated Tablets', 'type': 'DRUG', 'description': 'Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days', 'armGroupLabels': ['Placebo 7.5 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}