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Ignite Creation Date: 2025-12-24 @ 11:42 PM

Ignite Modification Date: 2026-02-21 @ 11:19 PM

Study NCT ID: NCT02349451

Status: COMPLETED

Last Update Posted: 2017-08-04

First Post: 2015-01-23

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Bulgaria', 'Czechia', 'France', 'Germany', 'Hungary', 'Italy', 'Latvia', 'New Zealand', 'Poland', 'Romania', 'Spain', 'United States']}, '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': 'D000068879', 'term': 'Adalimumab'}, {'id': 'C000625317', 'term': 'ABT-122'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks).', 'description': 'A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks', 'otherNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks', 'otherNumAtRisk': 72, 'otherNumAffected': 39, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks', 'otherNumAtRisk': 71, 'otherNumAffected': 33, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks', 'otherNumAtRisk': 73, 'otherNumAffected': 33, 'seriousNumAtRisk': 73, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'GRANULOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'LYMPHOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'SINUS TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'HYDROCELE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'BLEPHARITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'ERYTHEMA OF EYELID', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'MYOPIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'RETINAL VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'FOOD POISONING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'HAEMATOCHEZIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'ORAL MUCOSA EROSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'GAIT DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INJECTION SITE BRUISING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INJECTION SITE HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INJECTION SITE INDURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INJECTION SITE OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INJECTION SITE PAPULE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'INJECTION SITE PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'PERIPHERAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'VESSEL PUNCTURE SITE PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'BILE DUCT OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'HYPERBILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'HYPERTRANSAMINASAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'ACUTE SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'OSTEOPOROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 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'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'RHINITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'SINUS PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'THROAT IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'DERMATITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'PSORIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, 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'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'PHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'seriousEvents': [{'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'SKIN ABRASION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'UPPER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'HEART RATE DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks'}, {'id': 'OG001', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'OG002', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '45.2'}, {'value': '64.8', 'groupId': 'OG001', 'lowerLimit': '53.2', 'upperLimit': '74.9'}, {'value': '75.3', 'groupId': 'OG002', 'lowerLimit': '64.3', 'upperLimit': '83.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.8', 'ciLowerLimit': '17.2', 'ciUpperLimit': '57.7', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.3', 'ciLowerLimit': '28.1', 'ciUpperLimit': '67.4', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein \\[hsCRP\\]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Non-responder imputation (NRI): missing responses are imputed as non-responders.'}, {'type': 'SECONDARY', 'title': 'ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks'}, {'id': 'OG001', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'OG002', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '56.6', 'upperLimit': '77.7'}, {'value': '64.8', 'groupId': 'OG001', 'lowerLimit': '53.2', 'upperLimit': '74.9'}, {'value': '75.3', 'groupId': 'OG002', 'lowerLimit': '64.3', 'upperLimit': '83.9'}]}]}], 'analyses': [{'pValue': '0.723', 'groupIds': ['OG000', 'OG001'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-18.5', 'ciUpperLimit': '12.1', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.215', 'groupIds': ['OG000', 'OG002'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.3', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '21.6', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.'}, {'type': 'SECONDARY', 'title': 'ACR50 Response Rate at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks'}, {'id': 'OG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks'}, {'id': 'OG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'OG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '31.8'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '27.2', 'upperLimit': '49.1'}, {'value': '36.6', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '48.3'}, {'value': '53.4', 'groupId': 'OG003', 'lowerLimit': '42.1', 'upperLimit': '64.4'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG002'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.1', 'ciLowerLimit': '3.9', 'ciUpperLimit': '39.3', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.611', 'groupIds': ['OG001', 'OG002'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '14.8', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.9', 'ciLowerLimit': '20.1', 'ciUpperLimit': '55.8', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.039', 'groupIds': ['OG001', 'OG003'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.9', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '31.3', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.'}, {'type': 'SECONDARY', 'title': 'ACR70 Response Rate at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks'}, {'id': 'OG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks'}, {'id': 'OG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'OG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '21.9'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '25.5'}, {'value': '22.5', 'groupId': 'OG002', 'lowerLimit': '14.3', 'upperLimit': '33.6'}, {'value': '31.5', 'groupId': 'OG003', 'lowerLimit': '22.0', 'upperLimit': '42.9'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.4', 'ciLowerLimit': '1.5', 'ciUpperLimit': '29.7', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.185', 'groupIds': ['OG001', 'OG002'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.3', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '19.9', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG003'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.3', 'ciLowerLimit': '9.6', 'ciUpperLimit': '39.0', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.017', 'groupIds': ['OG001', 'OG003'], 'paramType': 'response rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.2', 'ciLowerLimit': '2.3', 'ciUpperLimit': '29.3', 'pValueComment': "P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.'}, {'type': 'SECONDARY', 'title': 'ACRn at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks'}, {'id': 'OG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks'}, {'id': 'OG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'OG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.3', 'groupId': 'OG000', 'lowerLimit': '-59.6', 'upperLimit': '19.1'}, {'value': '38.2', 'groupId': 'OG001', 'lowerLimit': '29.2', 'upperLimit': '47.2'}, {'value': '34.7', 'groupId': 'OG002', 'lowerLimit': '25.5', 'upperLimit': '44.0'}, {'value': '48.6', 'groupId': 'OG003', 'lowerLimit': '41.1', 'upperLimit': '56.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.', 'statisticalMethod': 'Kolmogorov-Smirnov test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.561', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.', 'statisticalMethod': 'Kolmogorov-Smirnov test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.', 'statisticalMethod': 'Kolmogorov-Smirnov test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.106', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.', 'statisticalMethod': 'Kolmogorov-Smirnov test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At Week 12', 'description': 'ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.', 'unitOfMeasure': 'percentage improvement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF): missing responses are imputed by calculation based on the last non-missing post-baseline component values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks'}, {'id': 'OG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks'}, {'id': 'OG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'OG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.89', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '-0.45'}, {'value': '-1.83', 'groupId': 'OG001', 'lowerLimit': '-2.08', 'upperLimit': '-1.58'}, {'value': '-1.96', 'groupId': 'OG002', 'lowerLimit': '-2.21', 'upperLimit': '-1.70'}, {'value': '-2.28', 'groupId': 'OG003', 'lowerLimit': '-2.53', 'upperLimit': '-2.03'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-1.58', 'ciUpperLimit': '-0.57', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.479', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.23', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.40', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '-0.89', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.012', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '-0.10', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks'}, {'id': 'OG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks'}, {'id': 'OG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'OG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.46', 'groupId': 'OG000', 'lowerLimit': '-2.01', 'upperLimit': '-0.90'}, {'value': '-2.53', 'groupId': 'OG001', 'lowerLimit': '-2.85', 'upperLimit': '-2.22'}, {'value': '-2.62', 'groupId': 'OG002', 'lowerLimit': '-2.94', 'upperLimit': '-2.31'}, {'value': '-2.86', 'groupId': 'OG003', 'lowerLimit': '-3.18', 'upperLimit': '-2.55'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '-0.53', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.696', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.36', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.41', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '-0.77', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.151', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.12', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Psoriasis Target Lesion Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks'}, {'id': 'OG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks'}, {'id': 'OG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'OG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.81', 'groupId': 'OG000', 'lowerLimit': '-2.65', 'upperLimit': '-0.96'}, {'value': '-4.16', 'groupId': 'OG001', 'lowerLimit': '-4.65', 'upperLimit': '-3.67'}, {'value': '-4.98', 'groupId': 'OG002', 'lowerLimit': '-5.47', 'upperLimit': '-4.49'}, {'value': '-4.53', 'groupId': 'OG003', 'lowerLimit': '-5.02', 'upperLimit': '-4.05'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.17', 'ciLowerLimit': '-4.14', 'ciUpperLimit': '-2.19', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '-0.12', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.73', 'ciLowerLimit': '-3.70', 'ciUpperLimit': '-1.75', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.288', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.32', 'pValueComment': 'Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered every week (EW) for 12 weeks'}, {'id': 'FG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks'}, {'id': 'FG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'FG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo EW', 'description': 'Double-blind placebo administered EW for 12 weeks'}, {'id': 'BG001', 'title': 'Adalimumab 40 mg EOW', 'description': 'Double-blind adalimumab 40 mg administered EOW for 12 weeks'}, {'id': 'BG002', 'title': 'ABT-122 120 mg EW', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks'}, {'id': 'BG003', 'title': 'ABT-122 240 mg EW', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'spread': '13.67', 'groupId': 'BG000'}, {'value': '50.5', 'spread': '12.03', 'groupId': 'BG001'}, {'value': '51.0', 'spread': '12.39', 'groupId': 'BG002'}, {'value': '47.4', 'spread': '13.77', 'groupId': 'BG003'}, {'value': '49.4', 'spread': '12.87', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set: randomized participants who received at least 1 dose of study medication.'}}, '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': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2015-01-23', 'resultsFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-02', 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein \\[hsCRP\\]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.'}], 'secondaryOutcomes': [{'measure': 'ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.'}, {'measure': 'ACR50 Response Rate at Week 12', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.'}, {'measure': 'ACR70 Response Rate at Week 12', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.'}, {'measure': 'ACRn at Week 12', 'timeFrame': 'At Week 12', 'description': 'ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.'}, {'measure': 'Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.'}, {'measure': 'Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Psoriasis Target Lesion Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Efficacy', 'Methotrexate'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '30376130', 'type': 'DERIVED', 'citation': 'Khatri A, Klunder B, Peloso PM, Othman AA. Exposure-response analyses demonstrate no evidence of interleukin 17A contribution to efficacy of ABT-122 in rheumatoid or psoriatic arthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):352-360. doi: 10.1093/rheumatology/key312.'}, {'pmid': '29855175', 'type': 'DERIVED', 'citation': 'Mease PJ, Genovese MC, Weinblatt ME, Peloso PM, Chen K, Othman AA, Li Y, Mansikka HT, Khatri A, Wishart N, Liu J. Phase II Study of ABT-122, a Tumor Necrosis Factor- and Interleukin-17A-Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2018 Nov;70(11):1778-1789. doi: 10.1002/art.40579.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Humira Prescribing info'}]}, 'descriptionModule': {'briefSummary': 'This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants with active PsA who are inadequately responding to MTX treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PsA diagnosis of at least 3 months duration prior to the date of first screening with ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.\n* Have active psoriasis defined by at least 1 psoriasis lesion \\>= 2 cm diameter in areas other than the axilla or groin.\n* Have active arthritis defined by minimum disease activity criteria:\n\n 1. \\>= 3 swollen joints (based on 66 joint counts) at Screening\n 2. \\>= 3 tender joints (based on 68 joint counts) at Screening\n* On a stable dose of methotrexate (MTX) defined as:\n\n 1. Oral or parenteral treatment \\>= 3 months\n 2. On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline\n 3. Stable MTX dose of \\>= 10 mg/week and \\<= the upper limit of the applicable approved local label\n 4. Can also be on stable doses of nonsteroidal anti-inflammatory drugs, sulfasalazine and/or hydroxychloroquine as long as they are also on methotrexate\n\nExclusion Criteria:\n\n* Up to 30% (approximately 66 subjects) with prior exposure to a TNF inhibitor may be enrolled if the TNF inhibitor was not discontinued due to lack of efficacy or safety concerns. Subjects must be washed out for at least 5 half-lives of these drugs prior to the Baseline visit.\n* Subjects on prior adalimumab may not be enrolled in the study\n* Prior exposure to other non-TNF inhibitor biological disease-modifying antirheumatic drugs (DMARDs) will be permitted if the subject is washed out at least 5 half-lives of these drugs prior to the baseline visit.\n* Current treatment with traditional oral/intramuscular DMARDs, including conventional synthetic DMARDs (csDMARDs; except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out for at least 5 half-lives of a drug apart from MTX prior to the Baseline visit.\n\n a. Subject could have been exposed to prior Janus kinase (JAK) or phosphodiesterase type 4 (PDE4) inhibitors so long as they have been off therapy for at least 5 half-lives.\n* Stable prescribed dose of oral prednisone or prednisone equivalent \\> 10 mg/day within the 30 days of the Baseline visit.\n* Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.\n* Laboratory values of the following at the Screening Visit:\n\n 1. Confirmed hemoglobin \\< 9 g/dL for males and \\< 8.5 g/dL for females\n 2. Absolute neutrophil count (ANC) \\< 1500 mm\\^3, (or \\< 1200 cells/µL for subjects of African descent who are black)\n 3. Aspartate aminotransferase or alanine aminotransferase \\> 1.5 x the upper limit of normal (ULN) or bilirubin \\>= 3 mg/dL\n 4. Serum creatinine \\> 1.5 x the ULN\n 5. Platelets \\< 100,000 cells/\\[mm\\^3\\] (10\\^9/L),\n 6. Clinically significant abnormal screening laboratory results as evaluated by the Investigator'}, 'identificationModule': {'nctId': 'NCT02349451', 'briefTitle': 'A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response to Methotrexate', 'orgStudyIdInfo': {'id': 'M14-197'}, 'secondaryIdInfos': [{'id': '2014-003558-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adalimumab', 'description': 'Double-blind adalimumab 40 mg administered every other week (EOW) for 12 weeks', 'interventionNames': ['Biological: adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Double-blind placebo administered every week (EW) for 12 weeks', 'interventionNames': ['Biological: ABT-122']}, {'type': 'EXPERIMENTAL', 'label': 'ABT-122 120 mg', 'description': 'Double-blind ABT-122 120 mg administered EW for 12 weeks', 'interventionNames': ['Biological: ABT-122']}, {'type': 'EXPERIMENTAL', 'label': 'ABT-122 240 mg', 'description': 'Double-blind ABT-122 240 mg administered EW for 12 weeks', 'interventionNames': ['Biological: ABT-122']}], 'interventions': [{'name': 'adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Humira', 'ABT-D2E7'], 'armGroupLabels': ['Adalimumab']}, {'name': 'ABT-122', 'type': 'BIOLOGICAL', 'otherNames': ['remtolumab'], 'armGroupLabels': ['ABT-122 120 mg', 'ABT-122 240 mg', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paul Peloso, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}