Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-01 @ 2:49 PM
Study NCT ID:
NCT01925768
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2013-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505730', 'term': 'apremilast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@Celgene.com', 'phone': '888-260-1599', 'title': 'Anne McClain, Senior Manager', 'organization': 'Celgene Corporation'}, 'certainAgreement': {'otherDetails': 'Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "AE's are reported: 1. Placebo-controlled phase (Weeks 0-24) 2. Up to 104 weeks for all participants randomized or transitioned onto apremilast at any time during the study (apremilast-exposure phase). AEs were monitored for 37 months", 'description': 'Median duration of exposure during the placebo-controlled phase was 24.14 weeks and 81 weeks during the apremilast exposure phase.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo-Controlled Phase: Placebo (Weeks 0-24)', 'description': 'Participants who were randomized to placebo tablets twice daily (BID) during the double-blind, 24-week placebo-controlled phase.', 'otherNumAtRisk': 109, 'otherNumAffected': 37, 'seriousNumAtRisk': 109, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo-Controlled Phase: Apremilast (Weeks 0-24)', 'description': 'Participants who were randomized to apremilast tablets twice daily during the double-blind, 24-week placebo-controlled phase.', 'otherNumAtRisk': 109, 'otherNumAffected': 41, 'seriousNumAtRisk': 109, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'APR Exposure Period: Apremilast', 'description': 'Participants who received apremilast any point during the course of the study, on Day 0, 16 or Day 24 and continued to receive apremilast 30 mg tablets BID up to week 104.', 'otherNumAtRisk': 206, 'otherNumAffected': 83, 'seriousNumAtRisk': 206, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Cardiomyopathy alcoholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Respiratory papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '38.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.7', 'ciLowerLimit': '6.2', 'ciUpperLimit': '29.3', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': "Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in 78 tender joint count;\n* ≥ 20% improvement in 76 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \\[NRS\\]);\n * Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population consisting of all participants randomized as specified in the protocol.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.169', 'spread': '0.0581', 'groupId': 'OG000'}, {'value': '-0.273', 'spread': '0.0572', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1677', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.103', 'ciLowerLimit': '-0.251', 'ciUpperLimit': '0.044', 'estimateComment': 'The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; Participants with a baseline and at least 1 postbaseline value during the placebo-controlled phase were included in the analysis (mixed effects model for repeated measure \\[MMRM\\])'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000'}, {'value': '43.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.5', 'ciLowerLimit': '6.3', 'ciUpperLimit': '30.6', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': "Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in 78 tender joint count;\n* ≥ 20% improvement in 76 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \\[NRS\\]);\n * Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the 28-Joint Disease Activity Score Using C-reactive Protein as the Acute-Phase Reactant (DAS28 [CRP]) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '0.138', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.15', 'estimateComment': 'The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "The DAS28 measures the severity of disease at a specific time and is derived from the following variables:\n\n* 28 tender joint count\n* 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;\n* C-reactive protein (CRP)\n* Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A higher value indicates higher disease activity, and a negative change from baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; Participants with a baseline value and at least one post-baseline value (after exclusion of data for early escaped participants) during the placebo-controlled phase are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'spread': '0.908', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '0.888', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.68', 'ciLowerLimit': '0.49', 'ciUpperLimit': '4.88', 'estimateComment': 'The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; Participants with a baseline and at least 1 postbaseline value during the placebo-controlled phase were included in the analysis (mixed effects model for repeated measure \\[MMRM\\])'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the 36-item SF-36 Physical Component Summary Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.60', 'spread': '0.959', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '0.949', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.40', 'ciLowerLimit': '1.10', 'ciUpperLimit': '5.70', 'pValueComment': 'Based on an MMRM model for the change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD use and baseline Oral Corticosteroids use as factors and the baseline value as a covariate.', 'groupDescription': '2-sided 95% CI for the difference in LS mean.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) score includes the physical functioning, role physical, bodily pain, and general health domains. Minimum clinically important difference (MCID) for the scale scores, as well as the PCS and MCS, is defined as a 2.5-point improvement (increase) from baseline. The summary scores range from 0 to 100, with lower scores reflecting more disability, and higher scores reflecting less disability and better health. The 8 domains are regrouped into the PCS and MCS scores.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set. Subjects with a baseline value and at least one post-baseline value (after exclusion of data for early escaped subjects) during the placebo-controlled phase are included in the MMRM model.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Duration of Morning Stiffness at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '137.11', 'groupId': 'OG000', 'lowerLimit': '-460', 'upperLimit': '-879'}, {'value': '-5.7', 'spread': '83.41', 'groupId': 'OG001', 'lowerLimit': '-175', 'upperLimit': '-679'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.0', 'ciLowerLimit': '-21.5', 'ciUpperLimit': '10.2', 'statisticalMethod': 'Sign test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'p-value based on distribution free signed rank test'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; Analysis includes participants with a baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improved Change in Severity of Morning Stiffness at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR)', 'description': 'Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.7', 'ciLowerLimit': '8.0', 'ciUpperLimit': '31.3', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline oral corticosteroids (prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': "Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. The response of no improvement includes subjects who had no change or worsened. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; Participants who withdrew early or who did not have sufficient data at Week 24 were counted as non-responders'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.055', 'spread': '0.0513', 'groupId': 'OG000'}, {'value': '-0.205', 'spread': '0.0523', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.150', 'ciLowerLimit': '-0.279', 'ciUpperLimit': '-0.021', 'estimateComment': 'The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants with a baseline value and at least 1 postbaseline value during the placebo-controlled phase were included in the mixed effects model for repeated measures (MRMM).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '0.133', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '-0.35', 'estimateComment': 'The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': "The DAS28 measures the severity of disease at a specific time and is derived from the following variables:\n\n* 28 tender joint count\n* 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;\n* C-reactive protein (CRP)\n* Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants with a baseline value and at least 1 postbaseline value during the placebo-controlled phase were included in the mixed effects model for repeated measures (MRMM).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2 Physical Functioning Domain at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.04', 'spread': '0.927', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '0.962', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.46', 'ciLowerLimit': '1.13', 'ciUpperLimit': '5.80', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants with a baseline value and at least 1 postbaseline value during the placebo-controlled phase were included in the mixed effects model for repeated measures (MRMM).'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the Duration of Morning Stiffness at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'spread': '136.85', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '60.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0168', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '20.0', 'estimateComment': 'Location shift and 95% CI based on Hodges-Lehmann for between treatment median estimates.', 'statisticalMethod': 'Stratified Van Elteren test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'p-value based on stratified Van Elteren test, using 2 stratification factors: previous DMARD use and baseline Oral Corticosteroids'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 16', 'description': "Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; Analysis includes participants with a baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}, {'value': '46.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.7', 'ciLowerLimit': '8.5', 'ciUpperLimit': '32.8', 'pValueComment': '2 sided-p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 16', 'description': "Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment. Full Analysis Set; Participants who discontinued early prior to Week 16 and those who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set; Participants who discontinued early prior to Week 16 and those who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, 6, 8, 12 and 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000'}, {'value': '37.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000'}, {'value': '43.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '1.6', 'ciUpperLimit': '17.7', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights', 'groupDescription': 'Week 2; 2-sided 95% CI is based on a normal approximation to the weighted average', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1121', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '18.9', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights', 'groupDescription': 'Week 4; 2-sided 95% CI is based on a normal approximation to the weighted average', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.8', 'ciLowerLimit': '6.2', 'ciUpperLimit': '29.3', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights', 'groupDescription': 'Week 6; 2-sided 95% CI is based on a normal approximation to the weighted average', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0392', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '0.8', 'ciUpperLimit': '24.6', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights', 'groupDescription': 'Week 8; 2-sided 95% CI is based on a normal approximation to the weighted average', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.0', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '23.2', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights', 'groupDescription': 'Week 12; 2-sided 95% CI is based on a normal approximation to the weighted average', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.6', 'ciLowerLimit': '6.5', 'ciUpperLimit': '30.7', 'pValueComment': 'Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.', 'estimateComment': 'Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights', 'groupDescription': 'Week 20; 2-sided 95% CI is based on a normal approximation to the weighted average', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 12 and 20', 'description': "Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in 78 tender joint count;\n* ≥ 20% improvement in 76 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \\[NRS\\]);\n * Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * C-Reactive Protein (CRP)", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants discontinued early prior to the visit and participants who did not have sufficient data for a definitive determination of response status for the visit were counted as nonresponders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Apremilast (PBO-APR)', 'description': 'Participants initially randomized to placebo tablets BID in the 24-week place controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who required EE were transitioned to apremilast 30 mg BID in a blinded fashion and remained on their original treatment assignment.'}, {'id': 'OG001', 'title': 'Apremilast (APR)', 'description': 'Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '49.1', 'upperLimit': '70.2'}, {'value': '67.1', 'groupId': 'OG001', 'lowerLimit': '55.6', 'upperLimit': '77.3'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.2', 'groupId': 'OG000', 'lowerLimit': '54.3', 'upperLimit': '76.8'}, {'value': '59.4', 'groupId': 'OG001', 'lowerLimit': '46.9', 'upperLimit': '71.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in 78 tender joint count;\n* ≥ 20% improvement in 76 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \\[NRS\\]);\n * Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * C-Reactive Protein (CRP)", 'unitOfMeasure': 'percentage of partcipants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Apremilast Participants as Randomized or Transitioned, which includes all participants who randomized or escaped/transitioned (at Week 16 or Week 24) to apremilast, and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 52 and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Apremilast (PBO-APR)', 'description': 'Participants initially randomized to placebo tablets BID in the 24-week place controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who required EE were transitioned to apremilast 30 mg BID in a blinded fashion and remained on their original treatment assignment.'}, {'id': 'OG001', 'title': 'Apremilast (APR)', 'description': 'Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.323', 'spread': '0.5759', 'groupId': 'OG000'}, {'value': '-0.395', 'spread': '0.5297', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.382', 'spread': '0.5639', 'groupId': 'OG000'}, {'value': '-0.357', 'spread': '0.6102', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': 'HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Apremilast participants as randomized or transitioned; The Placebo/Apremilast 30 mg BID group includes participants initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24 and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Apremilast (PBO-APR)', 'description': 'Participants initially randomized to placebo tablets BID in the 24-week place controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who required EE were transitioned to apremilast 30 mg BID in a blinded fashion and remained on their original treatment assignment.'}, {'id': 'OG001', 'title': 'Apremilast (APR)', 'description': 'Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.46', 'spread': '0.985', 'groupId': 'OG000'}, {'value': '-1.71', 'spread': '1.054', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '1.086', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '1.305', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "The DAS28 measures the severity of disease at a specific time and is derived from the following variables:\n\n* 28 tender joint count\n* 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;\n* C-reactive protein (CRP)\n* Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Apremilast participants as randomized or transitioned. The Placebo/Apremilast30 mg BID group includes participants initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24 and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Domain Score at Weeks 52 and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Apremilast (PBO-APR)', 'description': 'Participants initially randomized to placebo tablets BID in the 24-week place controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who required EE were transitioned to apremilast 30 mg BID in a blinded fashion and remained on their original treatment assignment.'}, {'id': 'OG001', 'title': 'Apremilast (APR)', 'description': 'Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.11', 'spread': '9.842', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '9.990', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.78', 'spread': '9.932', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '10.827', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': 'The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Apremilast Subjects as Randomized or Transitioned; The Placebo/30 mg BID group includes participants initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Apremilast (PBO-APR)', 'description': 'Participants initially randomized to placebo tablets BID in the 24-week place controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who required EE were transitioned to apremilast 30 mg BID in a blinded fashion and remained on their original treatment assignment.'}, {'id': 'OG001', 'title': 'Apremilast (APR)', 'description': 'Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '174.41', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '93.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '165.36', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '71.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Apremilast participants as randomized or transitioned; The Placebo/ Apremilast 30 mg BID group includes participants initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24 And with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Whose Severity of Morning Stiffness at Week 52 and 104 Improved From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Apremilast (PBO-APR)', 'description': 'Participants initially randomized to placebo tablets BID in the 24-week place controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who required EE were transitioned to apremilast 30 mg BID in a blinded fashion and remained on their original treatment assignment.'}, {'id': 'OG001', 'title': 'Apremilast (APR)', 'description': 'Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}], 'classes': [{'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '57.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '59.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Apremilast participants as randomized or transitioned. The Placebo/30 mg BID group includes subjects initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24 and with available data at each time point'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'OG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Any drug-related TEAE', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Any severe TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any serious drug-related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE leading to study drug withdrawal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE leading to study dose interruption', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAE leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Date of first dose of study drug to Week 24; median duration of exposure during placebo controlled phase was 24.14 weeks', 'description': "A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all participants who were randomized and received at least one dose of IP.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-Exposure Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}]}]}, {'title': 'Any drug-related TEAE', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Any severe TEAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Any serious drug-related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any TEAE leading to study dose interruption', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Any TEAE leading to study drug withdrawal', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Any TEAE leading to death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Start of lst dose of IP up to week 104: Weeks 0 to104 for those initially randomized to APR 30 mg BID, Weeks 16 -104 for PBO-treated patients who EE to APR at Week 16 and from Weeks 24-104 for PBO-treated patients who transitioned to APR at Week 24', 'description': "A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APR participants as treated (AAT) population; AAT = participants who received at least 1 dose of APR at any time during the study, (those initially randomized to the APR 30 BID at Week 0, those initially randomized to placebo who entered EE and transitioned to APR at Week 16, and those initially randomized to PBO who transitioned to APR at Week 24)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Apremilast (PBO)', 'description': 'Participants were randomized to placebo tablets twice daily (BID) during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator and transitioned onto apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind, 24-week treatment phase entered into the blinded, active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. Participants who completed the active treatment phase entered into the open-label extension phase for an additional year (Week 52 to Week 104) continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}, {'id': 'FG001', 'title': 'Apremilast (APR)', 'description': 'Participants were randomized to apremilast 30 mg tablets BID during the double-blind, 24-week placebo-controlled phase. Those whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape. Participants who completed the double-blind 24-week treatment phase entered into the blinded active treatment phase for an additional 28 weeks (Week 24 to Week 52) and continued receiving Apremilast 30 mg tablets BID. All participants who completed the 52-week treatment phase entered into the open-label extension phase (Week 52 to Week 104) for an additional year continuing to receive apremilast 30 mg tablets BID until the end of the study (up to Week 104 visit) or until early discontinuation.'}], 'periods': [{'title': 'Placebo-controlled Phase (Week 0 - 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'Completed Week 16', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'Escaped Early (EE)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '3 participants who completed Week 24 did not enter the active treatment phase', 'groupId': 'FG000', 'numSubjects': '98'}, {'comment': '2 participants who completed Week 24 did not enter the active treatment phase', 'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'ActiveTreatment/Extension (Weeks 24-104)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'comment': 'Completed Apremilast treatment at Week 104', 'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study consisted of a 24-week randomized, double-blind, placebo-controlled treatment phase, followed by a 28-week active treatment phase and a 52-week open-label extension phase, for an overall study duration of 113 weeks. 219 subjects were enrolled from 59 centers across 10 countries.', 'preAssignmentDetails': 'Randomized participants were stratified by their baseline prednisone use (yes or no) and by their previous disease modifying antirheumatic drug (DMARD) use (excluding biologics). Participants were allowed to take non-steroidal anti-inflammatory agents and/or low dose corticosteroids during the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (PBO)', 'description': 'Participants randomized to placebo tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator were transitioned onto apremilast 30 mg tablets BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'BG001', 'title': 'Apremilast (APR) 30 mg', 'description': 'Participants randomized to apremilast 30 mg tablets BID during the blinded, 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator and continued receiving apremilast 30 mg BID in a blinded fashion. Those who had a 10% or more improvement in either swollen or tender joint counts at Week 16 were not eligible for early escape.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '13.75', 'groupId': 'BG000'}, {'value': '50.7', 'spread': '12.22', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '13.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Psoriatic Arthritis', 'classes': [{'categories': [{'measurements': [{'value': '3.59', 'spread': '5.497', 'groupId': 'BG000'}, {'value': '4.04', 'spread': '4.482', 'groupId': 'BG001'}, {'value': '3.82', 'spread': '5.007', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Duration of Psoriatic Arthritis is reported as the time since diagnosis', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set consisting of all participants who were randomized as specified in the protocol.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2016-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-28', 'studyFirstSubmitDate': '2013-08-15', 'resultsFirstSubmitDate': '2016-02-25', 'studyFirstSubmitQcDate': '2013-08-16', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-05', 'studyFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in 78 tender joint count;\n* ≥ 20% improvement in 76 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \\[NRS\\]);\n * Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.'}, {'measure': 'Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in 78 tender joint count;\n* ≥ 20% improvement in 76 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \\[NRS\\]);\n * Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders."}, {'measure': 'Change From Baseline in the 28-Joint Disease Activity Score Using C-reactive Protein as the Acute-Phase Reactant (DAS28 [CRP]) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "The DAS28 measures the severity of disease at a specific time and is derived from the following variables:\n\n* 28 tender joint count\n* 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;\n* C-reactive protein (CRP)\n* Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A higher value indicates higher disease activity, and a negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.'}, {'measure': 'Change From Baseline in the 36-item SF-36 Physical Component Summary Score at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) score includes the physical functioning, role physical, bodily pain, and general health domains. Minimum clinically important difference (MCID) for the scale scores, as well as the PCS and MCS, is defined as a 2.5-point improvement (increase) from baseline. The summary scores range from 0 to 100, with lower scores reflecting more disability, and higher scores reflecting less disability and better health. The 8 domains are regrouped into the PCS and MCS scores.'}, {'measure': 'Change From Baseline in the Duration of Morning Stiffness at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement."}, {'measure': 'Percentage of Participants With Improved Change in Severity of Morning Stiffness at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. The response of no improvement includes subjects who had no change or worsened. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "The DAS28 measures the severity of disease at a specific time and is derived from the following variables:\n\n* 28 tender joint count\n* 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;\n* C-reactive protein (CRP)\n* Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2 Physical Functioning Domain at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.'}, {'measure': 'Mean Change From Baseline in the Duration of Morning Stiffness at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': "Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement."}, {'measure': 'Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline', 'timeFrame': 'Baseline and Week 16', 'description': "Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment. Full Analysis Set; Participants who discontinued early prior to Week 16 and those who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders."}, {'measure': 'Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, 6, 8, 12 and 20', 'timeFrame': 'Baseline and at Weeks 2, 4, 6, 8, 12 and 20', 'description': "Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in 78 tender joint count;\n* ≥ 20% improvement in 76 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \\[NRS\\]);\n * Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * C-Reactive Protein (CRP)"}, {'measure': 'Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:\n\n* ≥ 20% improvement in 78 tender joint count;\n* ≥ 20% improvement in 76 swollen joint count; and\n* ≥ 20% improvement in at least 3 of the 5 following parameters:\n\n * Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale \\[NRS\\]);\n * Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);\n * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]);\n * C-Reactive Protein (CRP)"}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 52 and 104', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': 'HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "The DAS28 measures the severity of disease at a specific time and is derived from the following variables:\n\n* 28 tender joint count\n* 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;\n* C-reactive protein (CRP)\n* Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Domain Score at Weeks 52 and 104', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': 'The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.'}, {'measure': 'Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement."}, {'measure': 'Percentage of Participants Whose Severity of Morning Stiffness at Week 52 and 104 Improved From Baseline', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase', 'timeFrame': 'Date of first dose of study drug to Week 24; median duration of exposure during placebo controlled phase was 24.14 weeks', 'description': "A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-Exposure Period', 'timeFrame': 'Start of lst dose of IP up to week 104: Weeks 0 to104 for those initially randomized to APR 30 mg BID, Weeks 16 -104 for PBO-treated patients who EE to APR at Week 16 and from Weeks 24-104 for PBO-treated patients who transitioned to APR at Week 24', 'description': "A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Apremilast, Psoriatic Arthritis, PDE4 inhibitor'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '29343507', 'type': 'BACKGROUND', 'citation': 'Nash P, Ohson K, Walsh J, Delev N, Nguyen D, Teng L, Gomez-Reino JJ, Aelion JA; ACTIVE investigators. Early and sustained efficacy with apremilast monotherapy in biological-naive patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE). Ann Rheum Dis. 2018 May;77(5):690-698. doi: 10.1136/annrheumdis-2017-211568. Epub 2018 Jan 17.'}, {'pmid': '37316690', 'type': 'DERIVED', 'citation': "Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.', 'detailedDescription': 'This is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast monotherapy in subjects with active psoriatic arthritis.\n\nApproximately 214 subjects will be randomized in a 1:1 ratio to either apremilast 30 mg BID (twice a day) or identically-appearing placebo, with approximately 107 subjects per treatment group.\n\nThis is a 113-week study. The subjects will spend 24 weeks in the double-blind, placebo-controlled treatment phase, followed by 28 weeks of active treatment phase (ie, up to Week 52 visit). The original treatment assignments (apremilast 30 mg BID (twice a day) or placebo) will remain blinded until all subjects have completed their Week 52 visit (or have discontinued). After the Week 52 visit, all subjects in the extension phase will continue to receive treatment with apremilast 30 mg BID (twice a day) until the end of the study (ie, up to Week 104 visit) or until early discontinuation from the trial.\n\nThe study will consist of 5 phases:\n\n1. Screening Phase - up to 5 weeks\n2. Randomized, Placebo-controlled, Double Blind Treatment Phase - Weeks 0 to 24\n3. Active Treatment Phase - Week 24 to Week 52\n4. Open-label Extension Phase - Week 52 to Week 104\n5. Post-treatment Observational Follow-up Phase'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females, 18 years and older at time of consent.\n2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.\n3. Able to adhere to the study visit schedule and other protocol requirements.\n4. Have a documented diagnosis of psoriatic arthritis (by any criteria) of at least 3 months' duration\n5. Meet the classification criteria for psoriatic arthritis (CASPAR) at the time of screening.\n6. Have at least 3 swollen AND at least 3 tender joints.\n7. Must have high sensitivity C-Reactive Protein (hs-CRP) of at least 0.5 mg/dL at screening and at baseline.\n8. Must be receiving treatment on an outpatient basis.\n9. Must be tumor necrosis factor (TNF) blocker naive and other Biologic naïve for dermatologic and rheumatic conditions\n10. Subjects taking disease modifying anti-rheumatoid drugs (DMARDs), with the exception of cyclosporine and leflunomide (see 7.3. Exclusion Criteria 20, 21), do not require a washout, however, they must discontinue the DMARD treatment at least one day prior to their baseline visit (ie, Visit 2, Day 0)\n11. Subjects who have been previously treated with leflunomide will require a 12-week washout or treatment with the cholestyramine, per leflunomide prescribing label (ie. 8 g cholestyramine 3 times daily for 11 days.\n12. Subjects who have been previously treated with cyclosporine will require a 4-week washout prior to randomization to participate in the study\n13. If taking oral corticosteroids, must be on a stable dose of prednisone less than or equal to 10 mg/day or equivalent for at least 30 days prior to baseline visit (ie, Day 0)\n14. If taking nonsteroidal anti-inflammatory drugs (NSAIDs) or narcotic analgesics, must be on stable dose for at least 30 days prior to baseline visit (ie, Day 0) and until they have completed the Week 24 study visit.\n15. Must meet the following laboratory criteria:\n\n * White blood cell count greater than 3000/mm\\^3 (greater than 3.0 X 10\\^9/L) and less than 14,000/mm\\^3 (less than 14 X 10\\^9/L)\n * Platelet count at least 100,000/mm\\^3 (at least 100 X 10\\^9/L)\n * Serum creatinine less than or equal to 1.5 mg/dL (less than or equal to 132.6 μmol/L)\n * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to twice upper limit of normal (ULN). If initial test shows ALT or AST greater than 2 times the ULN, one repeat test is allowed during the screening period.\n * Total bilirubin less than or equal to 2 mg/dL (less than or equal to 34 μmol/L) or Albumin greater than LLN. If initial test result is greater than 2 mg/dL, one repeat test is allowed during the screening period.\n * Hemoglobin at least 9 g/dL (at least 5.6 mmol/L)\n * Hemoglobin A1c less than or equal to 9.0%\n16. All females of childbearing potential (FCBP) must use one of the approved contraceptive options as described below while on investigational product and for at least 28 days after administration of the last dose of the investigational product.\n\n At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the investigator will educate the subject regarding contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.\n\n Females of childbearing potential must have a negative pregnancy test at Screening and Baseline. All FCBP subjects who engage in activity in which conception is possible must use one of the approved contraceptive options described below:\n\n Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or non latex condom NOT made out of natural \\[animal\\] membrane \\[for example, polyurethane\\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.\n17. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural \\[animal\\] membrane \\[for example, polyurethane\\]) while on investigational product and for at least 28 days after the last dose of investigational product.\n\nExclusion Criteria:\n\n1. History of clinically significant (as determined by the investigator) cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.\n2. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.\n3. Clinically significant abnormality on a 12-lead electrocardiogram (ECG) at Screening.\n4. Pregnant or breast feeding.\n5. History of allergy to any component of the investigational product.\n6. Hepatitis B surface antigen positive at screening.\n7. Hepatitis C antibody positive at screening.\n8. History of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).\n9. Active tuberculosis or a history of incompletely treated tuberculosis.\n10. Clinically significant abnormality based upon chest radiograph with at least posterior-anterior (PA) view (the radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required.\n11. Active substance abuse or a history of substance abuse within 6 months prior to Screening.\n12. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening.\n13. Malignancy or history of malignancy, except for:\n\n 1. treated \\[ie, cured\\] basal cell or squamous cell in situ skin carcinomas;\n 2. treated \\[ie, cured\\] cervical intraepithelial neoplasia \\[CIN\\] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.\n14. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.\n15. Erythrodermic, guttate, or generalized pustular psoriasis at randomization.\n16. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or fibromyalgia.\n17. Functional Class IV, as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.\n18. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis (RA), ankylosing spondylitis, Lyme disease).\n19. Prior treatment with more than one non-biologic DMARD\n20. Use of the following systemic therapy(ies) within 4 weeks of randomization: cyclosporine or other calcineurin inhibitors, corticosteroids exceeding 10 mg daily prednisone equivalent, as well as other oral agents such as retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, tacrolimus.\n21. Use of leflunomide within 12 weeks of randomization, unless subject has taken cholestyramine, 8g TID (three times a day) x 11 days after stopping leflunomide.\n22. Previous treatment with biologic agents for rheumatic diseases such as, but not limited to: adalimumab, abatacept, canakinumab, etanercept, golimumab, infliximab, rilonacept, certolizumab pegol, or tocilizumab.\n23. Previous treatment with biologic agents for dermatologic diseases such as alefacept, anti-TNFs (eg etanercept, adalinumab) or ustekinumab.\n24. Previous treatment with tofacitinib, Anti IL-17 agents or secukinumab\n25. Previous treatment with any cell depleting therapies, including investigational agents (eg, rituximab, alemtuzumab, ocrelizumab, alemtuzumab, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20).\n26. Treatment with intravenous gamma globulin, plasmapheresis, or Prosorba® column\n27. Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.\n28. Prior treatment with any non-biologic DMARDS other than methotrexate, sulfasalazine, chloroquine, hydroxychloroquine, azathioprine, fumeric acid esters, cyclosporine, or leflunomide\n29. Prior treatment with apremilast, or participation in a clinical study, involving apremilast\n30. Use of any investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/ pharmacodynamic half lives, if known (whichever is longer)."}, 'identificationModule': {'nctId': 'NCT01925768', 'briefTitle': 'Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) Monotherapy in Subjects With Active Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'CC-10004-PSA-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apremilast 30 mg', 'description': '30 mg Apremilast tablets administered twice daily (BID) for 24 weeks during the double-blind placebo-controlled phase; followed by 30 mg Apremilast BID for 28 weeks of active treatment phase (up to the 52 week visit); original treatment assignments remain blinded until all participants have completed their 52 week visit or have discontinued. After the Wk 52 visit, all participants in the extension phase will continue to receive treatment with apremilast 30 mg BID until the end of the study (ie, up to Week 104 visit) or until early discontinuation from the trial.', 'interventionNames': ['Drug: Apremilast 30 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "Oral placebo BID during the placebo controlled phase weeks 0 to 24; placebo treated participants whose improvement is \\<10% in both swollen and tender joint counts at Week 16 are eligible for early escape (based on the measure of clinical benefit from their current treatment as evidenced by improvement (or lack of improvement) in 1) the physician (evaluator's) global assessment (EGA), 2) patients pain (pain NRS), 3) the patient global assessments (PGA), and 4) the health assessment questionnaire disability index (HAQ-DI); Placebo-treated patients who early escape are transitioned to apremilast 30 mg PO BID during the active treatment phase up to their Week 52 visit; all those who complete the 52-week treatment phase will enter an open-label extension phase for an additional 52 weeks or until early discontinuation from the trial.", 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Apremilast 30 mg', 'type': 'DRUG', 'otherNames': ['Otezla', 'CC-10004'], 'description': '30mg of Apremilast will be orally administered twice daily for 104 weeks', 'armGroupLabels': ['Apremilast 30 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Identically appearing Placebo tablets will be orally administered twice daily for up to 24 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Advances', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Area Arthritis and Osteoporosis', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Point Medical Group', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Palmetto Medical Research', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Jeffrey Alper MD Research', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Clinical Research', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '33612-4799', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83814', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': "Coeur D'Alene Arthritis Clinic", 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford Orthopedic Associates, LLC', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Advanced Rheumatology', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '59901', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'Research West Incorporated', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Heartland Clinical Research, Inc.', 'geoPoint': 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