Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-20 @ 3:57 PM
Study NCT ID:
NCT01064856
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2010-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Belgium', 'Canada', 'Czechia', 'France', 'Germany', 'Greece', 'Hungary', 'Ireland', 'Spain', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': 'Baseline (day of first study drug administration) through Week 156 plus 70 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.', 'otherNumAtRisk': 81, 'otherNumAffected': 33, 'seriousNumAtRisk': 81, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Double-blind Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.', 'otherNumAtRisk': 84, 'otherNumAffected': 30, 'seriousNumAtRisk': 84, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Any Adalimumab', 'description': 'All randomized participants who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).', 'otherNumAtRisk': 165, 'otherNumAffected': 139, 'seriousNumAtRisk': 165, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 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'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'LIGAMENT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'LIVER FUNCTION TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'SINUS CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'TONSILLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ABDOMINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ANAL FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'COLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, 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'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'FACIAL BONES FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'FIBULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'SKULL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'SACROILIITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'SPONDYLOARTHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'BENIGN OVARIAN TUMOUR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PHAEOCHROMOCYTOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'BRAIN STEM HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CERVICOBRACHIAL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'VASCULITIS CEREBRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CYSTITIS HAEMORRHAGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'RENAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PLEURISY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder', 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000'}, {'value': '80.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Pearson's chi-square", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of participants achieving the following composite response at Week 12: \\>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; \\>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and \\>= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug (ITT).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Any serious adverse event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any AE leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any severe AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any AE at least possibly drug related', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE at least possibly drug related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any infection', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (day of first study drug administration) through Week 156 plus 70 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analyses included all participants who received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.2', 'spread': '22.52', 'groupId': 'OG000'}, {'value': '-18.2', 'spread': '22.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': "The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 \\[none\\] to 10 \\[very severe\\] with one question's possible answers being in time increments \\[0 hours to ≥ 2 hours\\]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': "The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \\[without any difficulty\\] to 3 \\[unable to do\\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '6.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': "The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Leeds Enthesitis Index at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dactylitis at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': "Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values for both Baseline and the post-baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count (TJC) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '8.67', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '8.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Swollen Joint Count (SJC) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '5.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (\\< 1.3), moderate (≥ 1.3 to \\< 2.1), high (≥ 2.1 to ≤ 3.5), and very high (\\> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and with non-missing values for both Baseline and post-baseline visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'FG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}, {'id': 'FG002', 'title': 'Double-blind Adalimumab / Open-label Adalimumab', 'description': 'Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.'}, {'id': 'FG003', 'title': 'Double-blind Placebo / Open-label Adalimumab', 'description': 'Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.'}], 'periods': [{'title': 'Double-blind (DB) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'comment': 'This treatment group is not applicable for this period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'This treatment group is not applicable for this period.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Consent withdrawn by participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open-label (OL) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This treatment group is not applicable for this period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'This treatment group is not applicable for this period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '82'}, {'groupId': 'FG003', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Consent withdrawn by participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.'}, {'id': 'BG001', 'title': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '10.79', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '12.77', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '11.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tender Joint Count (78 Joints)', 'classes': [{'categories': [{'measurements': [{'value': '12.95', 'spread': '12.79', 'groupId': 'BG000'}, {'value': '13.62', 'spread': '16.10', 'groupId': 'BG001'}, {'value': '13.28', 'spread': '14.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 78 (worst possible score/ 78 joints with tenderness).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Swollen Joint Count (76 Joints)', 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'spread': '5.58', 'groupId': 'BG000'}, {'value': '7.31', 'spread': '7.99', 'groupId': 'BG001'}, {'value': '6.70', 'spread': '6.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 76 (worst possible score/ 76 joints with swelling).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)', 'classes': [{'categories': [{'measurements': [{'value': '3.13', 'spread': '3.60', 'groupId': 'BG000'}, {'value': '3.59', 'spread': '3.39', 'groupId': 'BG001'}, {'value': '3.36', 'spread': '3.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Assessment of enthesitis was performed in 7 domains. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Leeds Enthesitis Index', 'classes': [{'categories': [{'measurements': [{'value': '1.49', 'spread': '1.66', 'groupId': 'BG000'}, {'value': '1.42', 'spread': '1.61', 'groupId': 'BG001'}, {'value': '1.45', 'spread': '1.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Assessment of enthesitis was performed in 6 domains. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score', 'classes': [{'categories': [{'measurements': [{'value': '3.83', 'spread': '4.03', 'groupId': 'BG000'}, {'value': '4.05', 'spread': '3.78', 'groupId': 'BG001'}, {'value': '3.94', 'spread': '3.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Assessment of enthesitis was performed in 16 domains. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Enthesitis Count', 'classes': [{'categories': [{'measurements': [{'value': '6.73', 'spread': '6.95', 'groupId': 'BG000'}, {'value': '7.33', 'spread': '6.69', 'groupId': 'BG001'}, {'value': '7.02', 'spread': '6.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Total enthesitis count in the sum of all unique, individual enthesis location included in the Leeds, SPARCC and MASES entheses indices. Scores range from 0 (0 sites with enthesitis) to 29 (29 sites with enthesitis).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Global Assessment (PTGA) of Disease Activity', 'classes': [{'categories': [{'measurements': [{'value': '65.24', 'spread': '15.22', 'groupId': 'BG000'}, {'value': '66.43', 'spread': '15.86', 'groupId': 'BG001'}, {'value': '65.82', 'spread': '15.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'PTGA of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'PTGA - Pain', 'classes': [{'categories': [{'measurements': [{'value': '64.30', 'spread': '14.03', 'groupId': 'BG000'}, {'value': '65.60', 'spread': '15.89', 'groupId': 'BG001'}, {'value': '64.94', 'spread': '14.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physician Global Assessment (PGA) of Disease Activity', 'classes': [{'categories': [{'measurements': [{'value': '60.29', 'spread': '15.53', 'groupId': 'BG000'}, {'value': '57.02', 'spread': '14.98', 'groupId': 'BG001'}, {'value': '58.68', 'spread': '15.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'PGA of Disease Activity as measured by a 100 mm VAS where 0=no symptoms and 100=maximum symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ankylosing Spondylitis Disease Activity Score (ASDAS)', 'classes': [{'categories': [{'measurements': [{'value': '2.92', 'spread': '0.84', 'groupId': 'BG000'}, {'value': '3.06', 'spread': '0.80', 'groupId': 'BG001'}, {'value': '2.99', 'spread': '0.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (\\< 1.3), moderate (≥ 1.3 to \\< 2.1), high (≥ 2.1 to ≤ 3.5), and very high (\\> 3.5). One participant in the Placebo arm did not have a baseline ASDAS assessment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'classes': [{'categories': [{'measurements': [{'value': '5.68', 'spread': '1.74', 'groupId': 'BG000'}, {'value': '5.57', 'spread': '1.58', 'groupId': 'BG001'}, {'value': '5.62', 'spread': '1.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The BASDAI consisted of a VAS scale used to answer 6 questions pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 \\[none\\] to 10 \\[very severe\\] with one question's possible answers being in time increments \\[0 hours to ≥ 2 hours\\]). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dactylitis Count', 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'spread': '0.94', 'groupId': 'BG000'}, {'value': '0.65', 'spread': '1.25', 'groupId': 'BG001'}, {'value': '0.50', 'spread': '1.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (0 digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). One participant in the Double-blind (DB) Adalimumab arm did not have a baseline dactylitis count.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS)', 'classes': [{'categories': [{'measurements': [{'value': '34.56', 'spread': '7.93', 'groupId': 'BG000'}, {'value': '34.48', 'spread': '7.62', 'groupId': 'BG001'}, {'value': '34.52', 'spread': '7.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The SF-36™V2 is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. Scores range from 0 to 100. Higher scores indicate a better health state.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug (ITT).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2012-08-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2010-02-05', 'dispFirstSubmitQcDate': '2012-08-10', 'resultsFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2010-02-05', 'dispFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-04', 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12', 'timeFrame': 'Week 12', 'description': 'Percentage of participants achieving the following composite response at Week 12: \\>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; \\>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and \\>= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Baseline (day of first study drug administration) through Week 156 plus 70 days', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.'}, {'measure': 'Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': "The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 \\[none\\] to 10 \\[very severe\\] with one question's possible answers being in time increments \\[0 hours to ≥ 2 hours\\]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': "The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 \\[without any difficulty\\] to 3 \\[unable to do\\]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value."}, {'measure': 'Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': "The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state."}, {'measure': 'Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.'}, {'measure': 'Change From Baseline in Leeds Enthesitis Index at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.'}, {'measure': 'Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.'}, {'measure': 'Change From Baseline in Dactylitis at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': "Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value."}, {'measure': 'Change From Baseline in Tender Joint Count (TJC) at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.'}, {'measure': 'Change From Baseline in Swollen Joint Count (SJC) at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.'}, {'measure': 'Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12', 'timeFrame': 'Baseline (last measurement prior to first DB dose), Week 12', 'description': 'The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (\\< 1.3), moderate (≥ 1.3 to \\< 2.1), high (≥ 2.1 to ≤ 3.5), and very high (\\> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peripheral spondyloarthritis', 'adalimumab', 'humira'], 'conditions': ['Peripheral Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '25545240', 'type': 'BACKGROUND', 'citation': 'Mease P, Sieper J, Van den Bosch F, Rahman P, Karunaratne PM, Pangan AL. Randomized controlled trial of adalimumab in patients with nonpsoriatic peripheral spondyloarthritis. Arthritis Rheumatol. 2015 Apr;67(4):914-23. doi: 10.1002/art.39008.'}, {'pmid': '32937016', 'type': 'DERIVED', 'citation': 'Coates LC, Abraham S, Tillett W, Mease PJ, Ramiro S, Wu T, Wang X, Pangan AL, Song IH. Performance and Predictors of Minimal Disease Activity Response in Patients With Peripheral Spondyloarthritis Treated With Adalimumab. Arthritis Care Res (Hoboken). 2022 Feb;74(2):259-267. doi: 10.1002/acr.24442. Epub 2021 Dec 29.'}, {'pmid': '28298558', 'type': 'DERIVED', 'citation': 'Mease PJ, Van den Bosch F, Sieper J, Xia Y, Pangan AL, Song IH. Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab. J Rheumatol. 2017 May;44(5):599-608. doi: 10.3899/jrheum.160387. Epub 2017 Mar 15.'}, {'pmid': '26245756', 'type': 'DERIVED', 'citation': 'Turina MC, Ramiro S, Baeten DL, Mease P, Paramarta JE, Song IH, Pangan AL, Landewe R. A psychometric analysis of outcome measures in peripheral spondyloarthritis. Ann Rheum Dis. 2016 Jul;75(7):1302-7. doi: 10.1136/annrheumdis-2014-207235. Epub 2015 Aug 5.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to \\>= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants who had inadequate response to \\>= 2 non-steroidal anti-inflammatories (NSAIDs)\n* Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria\n* Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative\n* Ability to administer subcutaneous injections\n* General good health\n\nExclusion Criteria:\n\n* Prior anti-tumor necrosis factor (TNF) therapy\n* Psoriasis or Psoriatic Arthritis\n* Fulfillment of modified New York criteria for Ankylosing Spondylitis\n* Recent infection requiring treatment\n* Significant medical events or conditions that had put patients at risk for participation\n* Female participants who were pregnant or breast-feeding or considering becoming pregnant during the study\n* History of cancer, except successfully treated skin cancer\n* Recent history of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01064856', 'briefTitle': 'Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Peripheral Spondyloarthritis', 'orgStudyIdInfo': {'id': 'M10-883'}, 'secondaryIdInfos': [{'id': '2009-014567-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double-blind (DB) Adalimumab', 'description': 'Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-blind Placebo', 'description': 'Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Double-blind Adalimumab / Open-label Adalimumab', 'description': 'Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-blind Placebo / Open-label Adalimumab', 'description': 'Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.', 'interventionNames': ['Biological: Adalimumab', 'Biological: Placebo']}], 'interventions': [{'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['ABT-D2E7', 'Humira'], 'description': 'Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.', 'armGroupLabels': ['Double-blind (DB) Adalimumab', 'Double-blind Adalimumab / Open-label Adalimumab', 'Double-blind Placebo / Open-label Adalimumab']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.', 'armGroupLabels': ['Double-blind Placebo', 'Double-blind Placebo / Open-label Adalimumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'In-Ho Song, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}