Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-01-01 @ 6:45 AM
Study NCT ID:
NCT00456092
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
2007-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': '1-888-260-1599', 'title': 'Associate Director, Clinical Trials Disclosure', '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': 'Adverse events are reported for the 12-week placebo-controlled phase, including AEs that occurred during the 28-day observational follow-up, and for up to 24 weeks for all participants who were randomized or re-randomized to apremilast at any time during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Week 12: Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.', 'otherNumAtRisk': 67, 'otherNumAffected': 45, 'seriousNumAtRisk': 67, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Week 12: Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.', 'otherNumAtRisk': 69, 'otherNumAffected': 44, 'seriousNumAtRisk': 69, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Week 12: Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.', 'otherNumAtRisk': 68, 'otherNumAffected': 42, 'seriousNumAtRisk': 68, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Week 24: Apremilast 40 mg QD', 'description': 'Participants who received 40 mg QD apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24.', 'otherNumAtRisk': 87, 'otherNumAffected': 63, 'seriousNumAtRisk': 87, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Week 24: Apremilast 20 mg BID', 'description': 'Participants who received 20 mg apremilast BID, regardless of when the apremilast exposure started (at Week 0, 12), up until Week 24.', 'otherNumAtRisk': 89, 'otherNumAffected': 62, 'seriousNumAtRisk': 89, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oral neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neoplasm prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Modified American College of Rheumatology 20% (ACR 20) Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000'}, {'value': '43.5', 'groupId': 'OG001'}, {'value': '11.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.190', 'ciLowerLimit': '1.72', 'ciUpperLimit': '10.20', 'pValueComment': 'A p-value \\< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.770', 'ciLowerLimit': '2.40', 'ciUpperLimit': '13.88', 'pValueComment': 'A p-value \\< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "A modified American College of Rheumatology 20% (ACR 20) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population which consisted of all randomized participants with at least one of the ACR components assessed at baseline. Last observation carried forward (LOCF) imputation was used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events During the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'title': 'All adverse events', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': 'Adverse events related to study drug', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Severe adverse events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Severe adverse events related to study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse events related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Discontinued study drug due to adverse event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Discontinued due to AE related to study drug', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': "The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population which consisted of all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '52.2', 'groupId': 'OG001'}, {'value': '22.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures, according to the following: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with no post-baseline PsARC scores were considered non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Modified ACR 50 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.120', 'ciLowerLimit': '1.06', 'ciUpperLimit': '24.67', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.012', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.950', 'ciLowerLimit': '1.49', 'ciUpperLimit': '32.35', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "A modified American College of Rheumatology 50% (ACR 50) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Modified ACR 70 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.204', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.400', 'ciLowerLimit': '0.61', 'ciUpperLimit': '47.54', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.371', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.120', 'ciLowerLimit': '0.45', 'ciUpperLimit': '37.88', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "A modified American College of Rheumatology 70% (ACR 70) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response Based on Disease Activity Score (DAS28)-CRP(4) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}, {'value': '55.1', 'groupId': 'OG001'}, {'value': '38.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.264', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.568', 'ciLowerLimit': '0.79', 'ciUpperLimit': '3.11', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.071', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.980', 'ciLowerLimit': '1.00', 'ciUpperLimit': '3.91', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (TJC; does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count (SJC) • C-reactive protein (CRP) • Patient's global assessment of disease activity (GH) according to the formula: DAS28-CRP(4) = 0.56\\*√(TJC28) + 0.28\\*(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 \\> 1.2 from Baseline and a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 \\> 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 \\> 1.2 and a DAS28 score \\> 3.2", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; LOCF imputation was used. Participants with no baseline or post-baseline DAS28-CRP(4) scores were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}, {'value': '44.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.549', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.305', 'ciLowerLimit': '0.66', 'ciUpperLimit': '2.57', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.033', 'ciLowerLimit': '0.53', 'ciUpperLimit': '2.03', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = \\[0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.36\\*ln(CRP+1)\\] \\* 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 \\> 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 \\> 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 \\> 1.2 and a DAS28 score \\> 3.2', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; LOCF imputation was used. Participants with no baseline or post-baseline DAS28-CRP(3) scores were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28-CRP(4) Score of Mild Disease Activity or In Remission at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '23.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.060', 'ciLowerLimit': '0.98', 'ciUpperLimit': '4.34', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.279', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.630', 'ciLowerLimit': '0.77', 'ciUpperLimit': '3.44', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The DAS28-CRP(4) measures the severity of disease derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28-CRP(4) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(4) score of ≤ 3.2. In remission is defined as a DAS28-CRP(4) score of ≤ 2.6.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; LOCF imputation was used. Participants with no post-baseline DAS28-CRP(4) scores were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28-CRP(3) Score of Mild Disease Activity or In Remission at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}, {'value': '34.8', 'groupId': 'OG001'}, {'value': '33.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.548', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.320', 'ciLowerLimit': '0.66', 'ciUpperLimit': '2.66', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.040', 'ciLowerLimit': '0.52', 'ciUpperLimit': '2.11', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The DAS28-CRP(3) measures the severity of disease derived from the following 3 variables: • 28 tender joint count (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) DAS28-CRP(3) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(3) score of ≤ 3.2. In remission is defined as a DAS28-CRP(3) score of ≤ 2.6.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; LOCF imputation was used. Participants with no post-baseline DAS28-CRP(3) scores were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Withdrew Prematurely Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'The number of participants who withdrew prematurely from the treatment phase due to lack of efficacy, including flare of psoriasis, flare of psoriatic arthritis or worsening or not responding to study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Leading to a Dose Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 12', 'description': 'The number of participants who were dose reduced during the treatment phase due to adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Maximal ACR Response During the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '56.45', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '37.63', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '35.42', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.136', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '11.58', 'estimateComment': 'Treatment Difference = Apremilast 20 mg BID - Placebo', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model with treatment as the factor.'}, {'pValue': '0.080', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '13.53', 'estimateComment': 'Treatment Difference = Apremilast 20 mg BID - Placebo', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model with treatment as the factor.'}], 'paramType': 'MEAN', 'timeFrame': 'ACR was measured at Baseline and Weeks 2, 4, 6, 8, 10, and 12', 'description': "The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: - percent improvement from Baseline in the 76 swollen joint count, - percent improvement from Baseline in the 78 tender joint count - median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week treatment period was calculated, and represents the maximal ACR response achieved.", 'unitOfMeasure': 'percent improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with non-missing ACR data'}, {'type': 'SECONDARY', 'title': 'Time to ACR 20 Response During the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '43.0'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '57.0'}, {'value': '29.0', 'groupId': 'OG002', 'lowerLimit': '20.0', 'upperLimit': '47.0'}]}]}], 'analyses': [{'pValue': '0.650', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.950', 'ciLowerLimit': '0.745', 'ciUpperLimit': '1.211', 'estimateComment': 'Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.283', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.265', 'ciLowerLimit': '0.791', 'ciUpperLimit': '2.024', 'estimateComment': 'Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The Kaplan-Meier estimates of time to ACR 20 response was calculated for participants who had an ACR 20 response at any time during the treatment phase.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with an ACR 20 response during the treatment phase.'}, {'type': 'SECONDARY', 'title': 'Time to ACR 50 Response During the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '61.0'}, {'value': '57.5', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '72.0'}, {'value': '15.0', 'groupId': 'OG002', 'lowerLimit': '14.0', 'upperLimit': '73.0'}]}]}], 'analyses': [{'pValue': '0.253', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.337', 'ciLowerLimit': '0.791', 'ciUpperLimit': '2.260', 'estimateComment': 'Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.026', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.023', 'ciLowerLimit': '1.059', 'ciUpperLimit': '8.630', 'estimateComment': 'Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The Kaplan-Meier estimates of time to ACR 50 response was calculated for participants who had an ACR 50 response at any time during the treatment phase.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population who had an ACR 50 response during the treatment phase.'}, {'type': 'SECONDARY', 'title': 'Time to ACR 70 Response During the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000', 'lowerLimit': '47.0', 'upperLimit': '85.0'}, {'value': '57.0', 'groupId': 'OG001', 'lowerLimit': '43.0', 'upperLimit': '85.0'}, {'value': '58.0', 'groupId': 'OG002', 'lowerLimit': '31.0', 'upperLimit': '85.0'}]}]}], 'analyses': [{'pValue': '0.984', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.006', 'ciLowerLimit': '0.457', 'ciUpperLimit': '2.215', 'estimateComment': 'Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.836', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.872', 'ciLowerLimit': '0.158', 'ciUpperLimit': '4.797', 'estimateComment': 'Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 12', 'description': 'The Kaplan-Meier estimates of time to ACR 70 response was calculated for participants who had an ACR 70 response at any time during the treatment phase.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population with an ACR 70 response during the treatment phase.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dactylitis Severity Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '3.11', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '3.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Enthesitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'title': 'Achilles tendon into the calcaneous: Baseline', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '35.3', 'groupId': 'OG002'}]}]}, {'title': 'Achilles tendon into the calcaneous: Week 12', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}, {'title': 'Plantar fascia into the calcaneous: Baseline', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '26.1', 'groupId': 'OG001'}, {'value': '14.7', 'groupId': 'OG002'}]}]}, {'title': 'Plantar fascia into the calcaneous: Week 12', 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}], 'classes': [{'title': '1. From Week 12', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '29.0'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '29.0'}]}]}, {'title': '2. From Date of Maximal ACR Response', 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000', 'lowerLimit': '34.0', 'upperLimit': '73.0'}, {'value': '29.0', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Week 12 to end of 28-day observational follow-up (1) and from the date of maximal ACR during the 12-week Treatment Phase until the end of the 28-day observational follow-up phase (2).', 'description': 'Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit. The time to relapse during the Observational Phase was calculated from the time of maximum ACR reduction and from the date of the Final Treatment Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received apremilast and with an ACR 20 response at the Week 12 (or Early Termination) visit who did not enroll in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Relapsed During the Observational Follow-up Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28-day observational follow-up period following Week 12', 'description': 'Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received apremilast with an ACR 20 response at the Week 12 (or Early Termination) visit who did not enroll in the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form 36 (SF-36) Summary Physical and Mental Component Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'title': 'Mental Component', 'categories': [{'measurements': [{'value': '1.0', 'spread': '8.01', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '7.18', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '8.39', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component', 'categories': [{'measurements': [{'value': '2.1', 'spread': '5.94', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '7.89', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '6.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.308', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.4', 'estimateComment': 'Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.', 'groupDescription': 'Mental Component', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model including treatment group, methotrexate use, and baseline score.'}, {'pValue': '0.003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.1', 'estimateComment': 'Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.', 'groupDescription': 'Mental Component', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model including treatment group, methotrexate use, and baseline score.'}, {'pValue': '0.182', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.6', 'estimateComment': 'Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.', 'groupDescription': 'Physical Component', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model including treatment group, methotrexate use, and baseline score.'}, {'pValue': '0.026', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.7', 'estimateComment': 'Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.', 'groupDescription': 'Physical Component', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model including treatment group, methotrexate use, and baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The Medical Outcome SF 36-Item Health Survey, Version 2 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 summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.96', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '4.29', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '4.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.1', 'estimateComment': 'The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.'}, {'pValue': '0.105', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.4', 'estimateComment': 'The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': "The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks during the Treatment Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks during the Treatment Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '9.46', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '8.78', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '8.03', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.3', 'estimateComment': 'The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors and baseline score as the covariate.'}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.3', 'estimateComment': 'The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors with baseline score as the covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population; participants with a baseline value and at least 1 post-baseline value in the treatment period are included; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events During the Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'All adverse events', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events related to study drug', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Severe adverse events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Discontinued study drug due to adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Discontinued due to AE related to study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 12 to 24 (Extension Phase)', 'description': "The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population; participants who entered the Extension Phase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '55.0', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with missing data were considered non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Modified ACR 20 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'Response From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000'}, {'value': '42.5', 'groupId': 'OG001'}, {'value': '45.0', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}]}]}, {'title': 'Response From Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '15.4', 'groupId': 'OG002'}, {'value': '16.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': "A modified ACR 20 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase; LOCF imputation was used. For the analysis of response from Week 12 (Day 85), participants with a tender or swollen joint count of 0 at Day 85 were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Modified ACR 50 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'Response From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '15.0', 'groupId': 'OG003'}]}]}, {'title': 'Response From Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}, {'value': '15.4', 'groupId': 'OG002'}, {'value': '5.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': "A modified ACR 50 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase; LOCF imputation was used. For the analysis of response from Week 12 (Day 85), participants with a tender or swollen joint count of 0 at Day 85 were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Modified ACR 70 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}, {'value': '5.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': "A modified ACR 70 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1). Participants with no post-baseline ACR scores were considered non-responders.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(4) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': "The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein • Patient's global assessment of disease activity according to the formula: DAS28-CRP(4) = 0.56\\*√(TJC28) + 0.28\\*(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 \\> 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 \\> 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 \\> 1.2 and a DAS28 score \\> 3.2", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}, {'value': '65.0', 'groupId': 'OG002'}, {'value': '55.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = \\[0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.36\\*ln(CRP+1)\\] \\* 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 \\> 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 \\> 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 \\> 1.2 and a DAS28 score \\> 3.2', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Maximal ACR Response During the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '40.86', 'groupId': 'OG000'}, {'value': '30.4', 'spread': '36.77', 'groupId': 'OG001'}, {'value': '23.3', 'spread': '32.11', 'groupId': 'OG002'}, {'value': '34.2', 'spread': '31.16', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'ACR was measured at Baseline and Weeks 16, 20 and 24', 'description': "The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: • percent improvement from Baseline in the 76 swollen joint count, • percent improvement from Baseline in the 78 tender joint count • median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week extension period was calculated, and represents the maximal ACR response achieved.", 'unitOfMeasure': 'percent improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with non-missing ACR data'}, {'type': 'SECONDARY', 'title': 'Time to ACR 20 Response During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '44.0'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '59.0'}, {'value': '34.0', 'groupId': 'OG002', 'lowerLimit': '29.0', 'upperLimit': '55.0'}, {'value': '55.5', 'groupId': 'OG003', 'lowerLimit': '29.0', 'upperLimit': '57.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Time to ACR 20 was measured from the first dose of apremilast to the first time a participant achieved an ACR 20 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 20 response were calculated for participants who had an ACR 20 response at any time during the study.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with an ACR 20 response at any time during the study'}, {'type': 'SECONDARY', 'title': 'Time to ACR 50 Response During the Treatment and Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '110.0'}, {'value': '58.5', 'groupId': 'OG001', 'lowerLimit': '56.0', 'upperLimit': '86.0'}, {'value': '84.5', 'groupId': 'OG002', 'lowerLimit': '84.0', 'upperLimit': '85.0'}, {'value': '55.0', 'groupId': 'OG003', 'lowerLimit': '23.0', 'upperLimit': '57.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Time to ACR 50 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 50 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 50 response were calculated for participants who had an ACR 50 response at any time during the study.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with an ACR 50 response at any time during the study'}, {'type': 'SECONDARY', 'title': 'Time to ACR 70 Response During the Treatment and Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '138.0', 'groupId': 'OG000', 'lowerLimit': '85.0', 'upperLimit': '169.0'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '57.0', 'upperLimit': '141.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Time to ACR 70 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 70 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 70 response were calculated for participants who had an ACR 70 response at any time during the study.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with an ACR 70 response at any time during the study'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Week 12 in Dactylitis Severity Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '3.13', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '4.94', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '1.08', 'groupId': 'OG003'}]}]}, {'title': 'Change from Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '2.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60. Change in the dactylitis severity score was assessed from Baseline (Day 1) and from Week 12 (Day 85).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with a baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Enthesitis in the Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'Achilles tendon into the calcaneous: Week 12', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}]}]}, {'title': 'Achilles tendon into the calcaneous: Week 24', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '15.0', 'groupId': 'OG003'}]}]}, {'title': 'Plantar fascia into the calcaneous:Week 12', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}]}]}, {'title': 'Plantar fascia into the calcaneous: Week 24', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 and Week 24', 'description': 'Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase'}, {'type': 'SECONDARY', 'title': 'Time to Relapse of Psoriatic Arthritis After Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': '1. From Week 12', 'categories': [{'measurements': [{'value': '31.0', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': 'NA'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '38.0'}, {'value': '16.0', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '29.0', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': 'NA'}]}]}, {'title': '2. From Date of Maximal ACR Response', 'categories': [{'measurements': [{'value': '85.0', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG000', 'lowerLimit': '57.0', 'upperLimit': 'NA'}, {'value': '111', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': 'NA'}, {'value': '16.0', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '29.0', 'comment': 'Could not be estimated due to the low number of events', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Week 24 to the end of the 28-day follow-up (1) and from the date of maximal ACR until the end of the 28-day follow-up phase (2).', 'description': 'Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase (Week 24)/Early Termination Visit. The time to relapse during the Follow-up Phase was calculated from the time of maximum ACR reduction and from the date of the Final Extension Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an ACR 20 response at the Week 24 (or Early Termination) visit and entered the Follow-up Phase after the Extension Phase'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Relapsed After the Extension Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 to Week 28 (28-day follow-up period)', 'description': 'Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase/Early Termination Visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an ACR 20 response at the Week 24 (or Early Termination) visit and entered the Follow-up Phase after the Extension Phase'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Week 12 in SF-36 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'Mental Component: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '9.08', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '8.92', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '12.20', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '14.00', 'groupId': 'OG003'}]}]}, {'title': 'Mental Component: Change from Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '9.35', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '10.60', 'groupId': 'OG002'}, {'value': '-3.4', 'spread': '10.61', 'groupId': 'OG003'}]}]}, {'title': 'Physical Component: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '6.68', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '7.74', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '9.50', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '9.99', 'groupId': 'OG003'}]}]}, {'title': 'Physical Component: Change from Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '6.60', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '8.50', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '7.81', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': 'The Medical Outcome SF 36-Item Health Survey, Version 2 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 summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Week 12 in Dermatology Life Quality Index (DLQI) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '7.36', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '4.08', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '4.78', 'groupId': 'OG002'}, {'value': '-1.9', 'spread': '5.50', 'groupId': 'OG003'}]}]}, {'title': 'Change from Week 12', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '2.07', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '6.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': "The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much) The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline and Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.59', 'groupId': 'OG003'}]}]}, {'title': 'Change from Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': 'The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants who received apremilast 40 mg QD during the Treatment Phase continued to receive apremilast 40 mg QD for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants who received apremilast 20 mg BID during the Treatment Phase continued to receive apremilast 20 mg BID for an additional 12 weeks during the Extension Phase.'}, {'id': 'OG002', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase.'}, {'id': 'OG003', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase.'}], 'classes': [{'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '9.76', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '7.76', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '11.23', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '12.34', 'groupId': 'OG003'}]}]}, {'title': 'Change from Week 12', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '8.56', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '6.19', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '9.05', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '13.10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': 'The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the Extension Phase with a Baseline/Week 12 value and at least 1 post-baseline value in the extension period; LOCF imputation was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.'}, {'id': 'FG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast orally twice a day (BID) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 20 mg apremilast BID for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast orally BID for 12 weeks during the Treatment Phase. Participants who entered the Extension Phase were re-randomized on Day 85 to receive either 40 mg apremilast QD or 20 mg apremilast BID for 12 weeks.'}, {'id': 'FG003', 'title': 'Placebo/Apremilast 40 mg QD', 'description': 'Participants who received placebo during the Treatment Phase then received 40 mg apremilast orally QD for 12 weeks during the Extension Phase. The dose of apremilast was titrated starting at 10 mg QD during Days 85 to 87 followed by 20 mg QD during Days 88 to 91 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.'}, {'id': 'FG004', 'title': 'Placebo/Apremilast 20 mg BID', 'description': 'Participants who received placebo during the Treatment Phase then received 20 mg apremilast orally BID for 12 weeks during the Extension Phase. The dose of apremilast was titrated starting at 10 mg QD during Days 85 to 87 followed by 20 mg QD during Days 88 to 91 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.'}], 'periods': [{'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The Extension Phase was only open to participants enrolled after amendment 1 was in effect.', 'groupId': 'FG000', 'numSubjects': '46'}, {'comment': 'The Extension Phase was only open to participants enrolled after amendment 1 was in effect.', 'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'The Extension Phase was only open to participants enrolled after amendment 1 was in effect.', 'groupId': 'FG003', 'numSubjects': '20'}, {'comment': 'The Extension Phase was only open to participants enrolled after amendment 1 was in effect.', 'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Grade 2 or Greater AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Flare of Psoriatic Arthritis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Worsening / Not Responding to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': 'Treatment Phase (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Grade 2 or Greater Adverse Event (AE)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'AEs not Included in NCI Terminology', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Intolerability of the Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Flare of Psoriasis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Flare of Psoriatic Arthritis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Worsening / Not Responding to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled across 38 sites in Canada, Belgium, Germany, the Netherlands, and the United Kingdom.', 'preAssignmentDetails': 'Participants were randomized 1:1:1 to either apremilast 40 mg once daily, 20 mg twice daily, or placebo. On Day 85 participants originally randomized to placebo were re-randomized to receive apremilast; participants randomized to apremilast continued on the same dose regimen. Randomization was stratified based on methotrexate use at baseline.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast once daily (QD) for 12 weeks in the Treatment Phase.'}, {'id': 'BG001', 'title': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast twice a day (BID) for 12 weeks in the Treatment Phase.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to apremilast for 12 weeks during the Treatment Phase.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.9', 'spread': '11.17', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '12.58', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '10.80', 'groupId': 'BG002'}, {'value': '50.6', 'spread': '11.50', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '197', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian/Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'American Indian/Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Psoriatic Arthritis Disease Category', 'classes': [{'categories': [{'title': 'Asymmetrical Oligoarthritis', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': 'Predominant Spondylitis', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Symmetric Polyarthritis', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}, {'title': 'Arthritis Mutilans', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Predominant Distal Interphalgeal Involvement', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Missing/Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Psoriatic Arthritis', 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '8.73', 'groupId': 'BG000'}, {'value': '8.4', 'spread': '9.77', 'groupId': 'BG001'}, {'value': '7.3', 'spread': '6.74', 'groupId': 'BG002'}, {'value': '7.8', 'spread': '8.48', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pain/Tender Joint Score', 'classes': [{'categories': [{'measurements': [{'value': '23.2', 'spread': '17.63', 'groupId': 'BG000'}, {'value': '20.6', 'spread': '15.90', 'groupId': 'BG001'}, {'value': '21.3', 'spread': '15.55', 'groupId': 'BG002'}, {'value': '21.7', 'spread': '16.33', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The number of tender joints (joints with scores of 1 to 3), rated on a scale of 0 (no pain/tenderness) to 3 (severe pain - tender, winced, withdrew). The joint count included the 68 joints routinely utilized in the American College of Rheumatology (ACR) joint count for evaluation of rheumatoid arthritis, plus 10 additional joints often involved in psoriatic arthritis (the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers) for a total of 78 joints.', 'unitOfMeasure': 'joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Swollen Joint Score', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '4.94', 'groupId': 'BG000'}, {'value': '10.6', 'spread': '9.88', 'groupId': 'BG001'}, {'value': '9.5', 'spread': '9.68', 'groupId': 'BG002'}, {'value': '9.5', 'spread': '8.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The number of swollen joints noted by the examiner. The joint count included the 66 joints routinely utilized in the American College of Rheumatology (ACR) joint count for evaluation of rheumatoid arthritis, plus 10 additional joints often involved in psoriatic arthritis (the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers) for a total of 76 joints.', 'unitOfMeasure': 'joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Psoriasis Severity', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Mild', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Severe', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Psoriasis severity was assessed by the Investigator.', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Psoriasis', 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '13.62', 'groupId': 'BG000'}, {'value': '15.5', 'spread': '11.66', 'groupId': 'BG001'}, {'value': '15.8', 'spread': '13.22', 'groupId': 'BG002'}, {'value': '16.5', 'spread': '12.85', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Methotrexate Use', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'dispFirstSubmitDate': '2013-03-28', 'completionDateStruct': {'date': '2009-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-18', 'studyFirstSubmitDate': '2007-04-02', 'dispFirstSubmitQcDate': '2013-07-26', 'resultsFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2007-04-02', 'dispFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-21', 'studyFirstPostDateStruct': {'date': '2007-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Modified American College of Rheumatology 20% (ACR 20) Response at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "A modified American College of Rheumatology 20% (ACR 20) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events During the Treatment Phase', 'timeFrame': '12 weeks', 'description': "The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event."}, {'measure': 'Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures, according to the following: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with no post-baseline PsARC scores were considered non-responders.'}, {'measure': 'Percentage of Participants With a Modified ACR 50 Response at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "A modified American College of Rheumatology 50% (ACR 50) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders."}, {'measure': 'Percentage of Participants With a Modified ACR 70 Response at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "A modified American College of Rheumatology 70% (ACR 70) response was defined as a participant who met the following 3 criteria for improvement from Baseline: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-reactive protein. Participants with no post-baseline ACR scores were considered non-responders."}, {'measure': 'Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response Based on Disease Activity Score (DAS28)-CRP(4) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (TJC; does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count (SJC) • C-reactive protein (CRP) • Patient's global assessment of disease activity (GH) according to the formula: DAS28-CRP(4) = 0.56\\*√(TJC28) + 0.28\\*(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 \\> 1.2 from Baseline and a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 \\> 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 \\> 1.2 and a DAS28 score \\> 3.2"}, {'measure': 'Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = \\[0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.36\\*ln(CRP+1)\\] \\* 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 \\> 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 \\> 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 \\> 1.2 and a DAS28 score \\> 3.2'}, {'measure': 'Percentage of Participants With DAS28-CRP(4) Score of Mild Disease Activity or In Remission at Week 12', 'timeFrame': 'Week 12', 'description': "The DAS28-CRP(4) measures the severity of disease derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28-CRP(4) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(4) score of ≤ 3.2. In remission is defined as a DAS28-CRP(4) score of ≤ 2.6."}, {'measure': 'Percentage of Participants With DAS28-CRP(3) Score of Mild Disease Activity or In Remission at Week 12', 'timeFrame': 'Week 12', 'description': 'The DAS28-CRP(3) measures the severity of disease derived from the following 3 variables: • 28 tender joint count (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) DAS28-CRP(3) scores range from 0 to 9.4, where higher scores indicate more disease activity. Mild disease severity is defined as a DAS28-CRP(3) score of ≤ 3.2. In remission is defined as a DAS28-CRP(3) score of ≤ 2.6.'}, {'measure': 'Number of Participants Who Withdrew Prematurely Due to Lack of Efficacy', 'timeFrame': 'Baseline to Week 12', 'description': 'The number of participants who withdrew prematurely from the treatment phase due to lack of efficacy, including flare of psoriasis, flare of psoriatic arthritis or worsening or not responding to study treatment.'}, {'measure': 'Number of Participants With Adverse Events Leading to a Dose Reduction', 'timeFrame': 'Baseline to Week 12', 'description': 'The number of participants who were dose reduced during the treatment phase due to adverse events.'}, {'measure': 'Maximal ACR Response During the Treatment Phase', 'timeFrame': 'ACR was measured at Baseline and Weeks 2, 4, 6, 8, 10, and 12', 'description': "The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: - percent improvement from Baseline in the 76 swollen joint count, - percent improvement from Baseline in the 78 tender joint count - median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week treatment period was calculated, and represents the maximal ACR response achieved."}, {'measure': 'Time to ACR 20 Response During the Treatment Phase', 'timeFrame': 'Baseline to Week 12', 'description': 'The Kaplan-Meier estimates of time to ACR 20 response was calculated for participants who had an ACR 20 response at any time during the treatment phase.'}, {'measure': 'Time to ACR 50 Response During the Treatment Phase', 'timeFrame': 'Baseline to Week 12', 'description': 'The Kaplan-Meier estimates of time to ACR 50 response was calculated for participants who had an ACR 50 response at any time during the treatment phase.'}, {'measure': 'Time to ACR 70 Response During the Treatment Phase', 'timeFrame': 'Baseline to Week 12', 'description': 'The Kaplan-Meier estimates of time to ACR 70 response was calculated for participants who had an ACR 70 response at any time during the treatment phase.'}, {'measure': 'Change From Baseline in Dactylitis Severity Score at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60.'}, {'measure': 'Percentage of Participants With Enthesitis', 'timeFrame': 'Baseline and Week 12', 'description': 'Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.'}, {'measure': 'Time to Relapse of Psoriatic Arthritis During the Observational Follow-up Phase', 'timeFrame': 'From Week 12 to end of 28-day observational follow-up (1) and from the date of maximal ACR during the 12-week Treatment Phase until the end of the 28-day observational follow-up phase (2).', 'description': 'Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit. The time to relapse during the Observational Phase was calculated from the time of maximum ACR reduction and from the date of the Final Treatment Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.'}, {'measure': 'Number of Participants Who Relapsed During the Observational Follow-up Phase', 'timeFrame': '28-day observational follow-up period following Week 12', 'description': 'Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Observation Phase in participants who received apremilast and achieved at least an ACR 20 at their Final Treatment Phase/Early Termination Visit.'}, {'measure': 'Change From Baseline in Short Form 36 (SF-36) Summary Physical and Mental Component Scores at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The Medical Outcome SF 36-Item Health Survey, Version 2 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 summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': "The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life."}, {'measure': 'Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).'}, {'measure': 'Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.'}, {'measure': 'Number of Participants With Adverse Events During the Extension Phase', 'timeFrame': 'Weeks 12 to 24 (Extension Phase)', 'description': "The severity of each adverse event (AE) was graded based upon the participant's symptoms according to National Cancer Institute (NCI) Common Toxicity Criteria (CTCAE, Version 3.0), on a scale from 1 (Mild AE) to 5 (Death due to AE). Severe AEs are defined as NCI CTCAE grade 3 or higher. AEs related to study drug are those determined by the investigator as suspected to be related to study drug where a temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other medications, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. A serious adverse event (SAE) is any AE which: - Resulted in death - Was life-threatening - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity - Was a congenital anomaly/birth defect - Constituted an important medical event."}, {'measure': 'Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'A PsARC response is defined as improvement from Baseline in at least 2 of the following 4 measures, at least 1 of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • At least 30% improvement in the 78 tender joint count, • At least 30% improvement in the 76 swollen joint count, • At least 20% improvement in the patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • At least 20% improvement in the physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Participants with missing data were considered non-responders.'}, {'measure': 'Percentage of Participants With a Modified ACR 20 Response at Week 24', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': "A modified ACR 20 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 20% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders."}, {'measure': 'Percentage of Participants With a Modified ACR 50 Response at Week 24', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': "A modified ACR 50 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 50% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1) and from Week 12 (Day 85). Participants with no post-baseline ACR scores were considered non-responders."}, {'measure': 'Percentage of Participants With a Modified ACR 70 Response at Week 24', 'timeFrame': 'Baseline (Day 1) and Week 24', 'description': "A modified ACR 70 response was defined as a participant who met the following 3 criteria for improvement: • ≥ 70% improvement in 78 tender joint count (includes 10 additional joints often involved in psoriatic arthritis: the first carpometacarpal \\[CMC\\] and the distal interphalangeal \\[DIP\\] joints of the fingers); • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm VAS); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. Response at Week 24 was measured as improvement from Baseline (Day 1). Participants with no post-baseline ACR scores were considered non-responders."}, {'measure': 'Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(4) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "The DAS28 measures the severity of disease at a specific time. DAS28-CRP(4) is derived from the following 4 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein • Patient's global assessment of disease activity according to the formula: DAS28-CRP(4) = 0.56\\*√(TJC28) + 0.28\\*(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*GH + 0.96. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 \\> 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 \\> 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 \\> 1.2 and a DAS28 score \\> 3.2"}, {'measure': 'Percentage of Participants With Good or Moderate EULAR Response Based on DAS28-CRP(3) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The DAS28 measures the severity of disease at a specific time. DAS28-CRP(3) is derived from the following 3 variables: • 28 tender joint count, (does not include the DIP joints, the hip joint, or the joints below the knee) • 28 swollen joint count • C-reactive protein (CRP) according to the formula: DAS28-CRP(3) = \\[0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.36\\*ln(CRP+1)\\] \\* 1.10 + 1.15. DAS28 scores range from 0 to 9.4, where higher scores indicate more disease activity. A EULAR response reflects an improvement in disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 \\> 1.2 from Baseline and attainment of a DAS28 score ≤ 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 \\> 0.6 and ≤ 1.2 and a DAS28 score ≤ to 5.1 or, • an improvement (decrease) in the DAS28 \\> 1.2 and a DAS28 score \\> 3.2'}, {'measure': 'Maximal ACR Response During the Extension Period', 'timeFrame': 'ACR was measured at Baseline and Weeks 16, 20 and 24', 'description': "The ACR-N index score was calculated for each participant at each time point in the study according to the following definition: ACR-N = the lowest of the following 3 values: • percent improvement from Baseline in the 76 swollen joint count, • percent improvement from Baseline in the 78 tender joint count • median percent improvement from Baseline in the following 5 measures ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \\[VAS\\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \\[HAQ-DI\\]); ◦ C-reactive protein. The maximal ACR-N for each participant during the 12-week extension period was calculated, and represents the maximal ACR response achieved."}, {'measure': 'Time to ACR 20 Response During the Study', 'timeFrame': 'Baseline to Week 24', 'description': 'Time to ACR 20 was measured from the first dose of apremilast to the first time a participant achieved an ACR 20 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 20 response were calculated for participants who had an ACR 20 response at any time during the study.'}, {'measure': 'Time to ACR 50 Response During the Treatment and Extension Phase', 'timeFrame': 'Baseline to Week 24', 'description': 'Time to ACR 50 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 50 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 50 response were calculated for participants who had an ACR 50 response at any time during the study.'}, {'measure': 'Time to ACR 70 Response During the Treatment and Extension Phase', 'timeFrame': 'Baseline to Week 24', 'description': 'Time to ACR 70 response was measured from the first dose of apremilast to the first time a participant achieved an ACR 70 response in the treatment or extension phase. The Kaplan-Meier estimates of time to ACR 70 response were calculated for participants who had an ACR 70 response at any time during the study.'}, {'measure': 'Change From Baseline and Week 12 in Dactylitis Severity Score at Week 24', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated on a scale from 0 (no dactylitis) to 3 (severe dactylitis). The dactylitis severity score is the sum of the individual scores for each digit and ranges from 0 to 60. Change in the dactylitis severity score was assessed from Baseline (Day 1) and from Week 12 (Day 85).'}, {'measure': 'Percentage of Participants With Enthesitis in the Extension Phase', 'timeFrame': 'Week 12 and Week 24', 'description': 'Enthesitis is inflammation of the entheses, the sites where tendons or ligaments insert into the bone. Enthesitis is characterized by swelling, pain, and tenderness around the calcaneous, and occasionally by effusion in the bursa associated with this joint. The enthesitis assessment is an evaluation of inflammation at the insertions of the Achilles tendon into the calcaneous and of the plantar fascia into the calcaneous. Inflammation at 1 or more insertions on either the right or left side constituted a positive assessment.'}, {'measure': 'Time to Relapse of Psoriatic Arthritis After Extension Phase', 'timeFrame': 'From Week 24 to the end of the 28-day follow-up (1) and from the date of maximal ACR until the end of the 28-day follow-up phase (2).', 'description': 'Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase (Week 24)/Early Termination Visit. The time to relapse during the Follow-up Phase was calculated from the time of maximum ACR reduction and from the date of the Final Extension Phase visit. Participants classified as responders who did not relapse were censored at the day of the last follow-up.'}, {'measure': 'Number of Participants Who Relapsed After the Extension Phase', 'timeFrame': 'Week 24 to Week 28 (28-day follow-up period)', 'description': 'Relapse of psoriatic arthritis was defined as a 50% loss of the maximal ACR improvement during the Follow-up Phase in participants who achieved at least an ACR 20 at their Final Extension Phase/Early Termination Visit.'}, {'measure': 'Change From Baseline and Week 12 in SF-36 at Week 24', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': 'The Medical Outcome SF 36-Item Health Survey, Version 2 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 summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included other subscales: vitality, social functioning, role-emotional, and mental health. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10, where higher scores are associated with better functioning/quality of life. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale. A higher change from baseline indicates an improvement in better health results or functioning.'}, {'measure': 'Change From Baseline and Week 12 in Dermatology Life Quality Index (DLQI) at Week 24', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': "The DLQI is a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on participants' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, leisure, work, personal relationships, and treatment. Each question is answered on a scale from 0 (not at all) to 3 (very much) The total score ranges from 0 to 30 where a higher score indicates that a participant's dermatological condition has a greater impact on their daily life."}, {'measure': 'Change From Baseline and Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': 'The HAQ-DI is a self-administered instrument consisting of 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item asks over the past week whether a particular task can be performed. For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). The eight category scores are averaged into an overall HAQ-DI score on a scale from zero (no disability) to three (completely disabled).'}, {'measure': 'Change From Baseline in the Functional Assessment of Chronic Illness Therapy for Fatigue (FACIT-F) at Week 24', 'timeFrame': 'Baseline (Day 1), Week 12 (Day 85) and Week 24', 'description': 'The FACIT-Fatigue is a 13 item self-administered questionnaire that assesses both the physical and functional consequences of fatigue based on recall during the past 7 days. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total score ranges from 0 to 52 with higher scores representing less fatigue.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psoriatic arthritis', 'ACR', 'PASI', 'DAS', 'pharmacokinetic', 'biopsy'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '22806399', 'type': 'BACKGROUND', 'citation': 'Schett G, Wollenhaupt J, Papp K, Joos R, Rodrigues JF, Vessey AR, Hu C, Stevens R, de Vlam KL. Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2012 Oct;64(10):3156-67. doi: 10.1002/art.34627.'}, {'pmid': '23588944', 'type': 'RESULT', 'citation': 'Strand V, Schett G, Hu C, Stevens RM. Patient-reported Health-related Quality of Life with apremilast for psoriatic arthritis: a phase II, randomized, controlled study. J Rheumatol. 2013 Jul;40(7):1158-65. doi: 10.3899/jrheum.121200. Epub 2013 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'This study is to look at the preliminary efficacy and safety of 2 dose regimens of apremilast (20 mg twice a day and 40 mg once a day) versus placebo in patients with active psoriatic arthritis.', 'detailedDescription': 'Prior to the implementation of Amendment 1/UK3 the study consisted of 3 phases - pre-randomization up to 35 days, up to 84 days placebo-controlled treatment and a 28-day observational follow up. After the implementation of Amendment 1/UK3, the study consisted of 4 phases - pre-randomization up to 35 days, up to 84 days treatment in the placebo controlled treatment phase, up to 84 days treatment in the active treatment extension phase and a 28 day follow up. Participants who completed the treatment phase prior to implementation of amendment 1/UK3 did not have the option of entering the extension phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of psoriatic arthritis (Moll and Wright Criteria), including symmetrical or asymmetrical peripheral joint involvement for at least 6 months\n* Active psoriatic arthritis at the time of screening and baseline as defined by: 3 or more swollen joints AND 3 or more tender joints\n* Negative rheumatoid factor (RF)\n* If using methotrexate, be on methotrexate for at least 168 days (24 weeks) and be on a stable dose for at least 56 days prior to screening and throughout the study\n* If using oral corticosteroids, be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 28 days prior to screening and throughout the study\n* If using nonsteroidal anti-inflammatory drug (NSAID) therapy, be on a stable dose for at least 14 days prior to screening and throughout the study\n* Must meet the following laboratory criteria:\n\n * Hemoglobin ≥ 9 g/dL\n * Hematocrit ≥ 27%\n * White blood cell (WBC) count ≥ 3000/μL (≥ 3.0 X 10\\^9/L) and \\< 20,000/μL (\\< 20 X 10\\^9/L)\n * Neutrophils ≥ 1500 /μL (≥ 1.5 X 10\\^9/L)\n * Platelets ≥ 100,000 /μL (≥ 100 X 10\\^9/L)\n * Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)\n * Total bilirubin ≤ 2.0 mg/dL\n * Aspartate transaminase (AST \\[serum glutamic oxaloacetic transaminase, SGOT\\]) and alanine transaminase (ALT \\[serum glutamate pyruvic transaminase, SGPT\\]) ≤ 1.5x upper limit of normal (ULN)\n* Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO adequate forms of contraception while on study medication. A FCBP must agree to have pregnancy tests every 28 days while on study medication\n* Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for at least 84 days after taking the last dose of study medication\n\nExclusion Criteria:\n\nHistory of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases\n\n* 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\n* Pregnant or lactating female\n* History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred \\> 3 years prior to entry must have been effectively treated.\n* History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative \\[PPD\\] skin test or in vitro test \\[T SPOT®.TB, QuantiFERON Gold®\\])\n* Clinically significant abnormality on the chest x-ray (CXR) at screening\n* Current erythrodermic, guttate, or pustular forms of psoriasis\n* History of infected joint prosthesis within the past 5 years\n* Systemic therapy for psoriasis and/or psoriatic arthritis (except for methotrexate, ≤ 10 mg/day prednisone or equivalent, and NSAIDs) including, but not limited to, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids (including intra-articular), penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, and fumaric acid esters within 28 days of randomization and throughout the study\n* Topical therapy for the treatment of psoriasis including, but not limited to topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin within 14 days of randomization (Note: Topical background therapy for treatment of psoriasis is allowed, except within 24 hours of a study visit, as follows: mild or moderate potency corticosteroids for treatment of the palms, face, scalp, axillae, plantar surfaces, and groin in accordance with the manufacturer's suggested usage. Nonmedicated emollients \\[eg, Eucerin®\\] and tar shampoo are also allowed.)\n* Phototherapy (ultraviolet light A \\[UVA\\], narrow-band ultraviolet light B \\[NB-UVB\\], psoralens and long-wave ultraviolet radiation \\[PUVA\\]) within 28 days prior to randomization\n* Etanercept use within 56 days prior to randomization\n* Adalimumab, efalizumab, or infliximab use within 84 days prior to randomization\n* Alefacept use within 168 days (24 weeks) prior to randomization\n* Use of intra-articular corticosteroids within 28 days prior to randomization\n* Use of any investigational medication within 28 days prior to randomization or 5 half-lives if known (whichever is longer)\n* Any clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening\n* High-risk factor(s) for, or a history of, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus infection\n* History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas)\n* Evidence of skin conditions at the time of screening visit that would interfere with evaluations of the effect of study medication on psoriasis"}, 'identificationModule': {'nctId': 'NCT00456092', 'briefTitle': 'Phase II Study of Apremilast (CC-10004) in Adults With in Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Dose Regimens of CC-10004 in Subjects With Active Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'CC-10004-PSA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apremilast 40 mg QD', 'description': 'Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks.\n\nThe dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.', 'interventionNames': ['Drug: Apremilast']}, {'type': 'EXPERIMENTAL', 'label': 'Apremilast 20 mg BID', 'description': 'Participants received 20 mg apremilast orally twice a day (BID) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 20 mg apremilast BID for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication.', 'interventionNames': ['Drug: Apremilast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo to apremilast orally BID for 12 weeks during the Treatment Phase. Participants who entered the Extension Phase were re-randomized on Day 85 to receive either 40 mg apremilast QD or 20 mg apremilast BID for 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Apremilast', 'type': 'DRUG', 'otherNames': ['CC-10004', 'Otezla®'], 'description': 'Capsules for oral administration', 'armGroupLabels': ['Apremilast 20 mg BID', 'Apremilast 40 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules for oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3590', 'city': 'Diepenbeek', 'country': 'Belgium', 'facility': 'Universiteit Hasselt', 'geoPoint': {'lat': 50.90769, 'lon': 5.41875}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2170', 'city': 'Merksem', 'country': 'Belgium', 'facility': 'Jan Palfijn Ziekenhuis', 'geoPoint': {'lat': 51.24623, 'lon': 4.44903}}, {'zip': 'V5Z 1L7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'The Arthritis Research Centre of Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8P4Y3', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'A1B 3E1', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Nexus Clinical Research', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'L7R 4B7', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Burlington Rheumatology and Osteoporosis Clinic', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'L8N 2B6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'MAC Research Inc.', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N2M 5N6', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'K-W Musculoskeletal Research Inc.', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'L5M 2V8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley Rheumatology', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y 3R7', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Arthritis Program Research Group Inc', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'K1H 1A2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rheumatology Research Associates', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Center for Prognosis Studies in the Rheumatic Diseases University Health Network, Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5T 3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2J1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Probity Medical', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'N8X 5A6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Clinical Research and Arthritis Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Pointe-Claire', 'state': 'Quebec', 'country': 'Canada', 'facility': 'West Island Rheumatology Research Associates', 'geoPoint': {'lat': 45.44868, 'lon': -73.81669}}, {'zip': 'S7K 0H6', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Osteoporosis Center', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '97769', 'city': 'Bad Brückenau', 'country': 'Germany', 'facility': 'Capio Franz von Prümmer Klinik', 'geoPoint': {'lat': 50.30853, 'lon': 9.78985}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Free University of Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitaetsklinik Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitaetsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '22081', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Klinikum Eilbek', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitaet Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '44652', 'city': 'Herne', 'country': 'Germany', 'facility': 'Rheumazentrum Ruhrgebiet', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitaet Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitaetsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '80336', 'city': 'Munich', 'country': 'Germany', 'facility': 'University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Klinikum der Universität Munster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '91054', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Friedrich-Alexander University, Erlangen', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '2300', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Centre', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6500', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud University', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '2454 CH', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Hagaziekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': 'M6 8HD', 'city': 'Salford', 'state': 'Manchester', 'country': 'United Kingdom', 'facility': 'Hope Hospital', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'ST6 7AG', 'city': 'Stoke-on-Trent', 'state': 'Staffs', 'country': 'United Kingdom', 'facility': 'Haywood Hospital', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'LS7 4SA', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Chapel Allerton Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}