Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 11:52 PM
Study NCT ID:
NCT01468233
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2011-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Denmark', 'France', 'Greece', 'Netherlands', 'Puerto Rico', 'Sweden', 'Switzerland', 'Turkey (Türkiye)', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D005667', 'term': 'Furunculosis'}, {'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D013207', 'term': 'Staphylococcal Skin Infections'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D005393', 'term': 'Fish Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, '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 Information', 'organization': 'AbbVie (prior sponsor, Abbott)'}, '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': 'Adverse Events were collected from first dose of study drug until 70 days following last dose of study drug (46 weeks); Serious Adverse Events were collected from the time that informed consent was obtained (up to 50 weeks).', 'description': 'Adverse Events with onset in Period 1 were collected from first dose of study drug until prior to the first dose in Period 2, or up to 70 days following last dose of study drug if the participant discontinued during Period 1.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Period 1)', 'description': 'Placebo for 12 weeks.', 'otherNumAtRisk': 163, 'otherNumAffected': 77, 'seriousNumAtRisk': 163, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Adalimumab EW (Period 1)', 'description': 'Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).', 'otherNumAtRisk': 163, 'otherNumAffected': 66, 'seriousNumAtRisk': 163, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo/Placebo (Period 2)', 'description': 'Participants randomized to receive placebo in Period 1 received placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).', 'otherNumAtRisk': 151, 'otherNumAffected': 48, 'seriousNumAtRisk': 151, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Adalimumab EW/Placebo (Period 2)', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).', 'otherNumAtRisk': 51, 'otherNumAffected': 27, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Adalimumab EW/Adalimumab EOW (Period 2)', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).', 'otherNumAtRisk': 53, 'otherNumAffected': 25, 'seriousNumAtRisk': 53, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Adalimumab EW/Adalimumab EW (Period 2)', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).', 'otherNumAtRisk': 51, 'otherNumAffected': 21, 'seriousNumAtRisk': 51, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'FOLLICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'VITAMIN D DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DERMATITIS CONTACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'HIDRADENITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'LYMPHADENITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'CLOSTRIDIUM DIFFICILE INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'VIRAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ACCIDENTAL OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'TENDON RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'INTERNATIONAL NORMALISED RATIO INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DIABETES MELLITUS INADEQUATE CONTROL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'RENAL COLIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'HIDRADENITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'SEXUAL ABUSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'INTRA-ABDOMINAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 12 weeks'}, {'id': 'OG001', 'title': 'Adalimumab Every Week (EW)', 'description': 'Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).'}, {'id': 'OG002', 'title': 'Placebo - Baseline Hurley Stage II', 'description': 'Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks'}, {'id': 'OG003', 'title': 'Placebo - Baseline Hurley Stage III', 'description': 'Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.'}, {'id': 'OG004', 'title': 'Adalimumab Every Week (EW) - Baseline Hurley Stage II', 'description': 'Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).'}, {'id': 'OG005', 'title': 'Adalimumab Every Week (EW) - Baseline Hurley Stage III', 'description': 'Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000'}, {'value': '58.9', 'groupId': 'OG001'}, {'value': '36.8', 'groupId': 'OG002'}, {'value': '17.1', 'groupId': 'OG003'}, {'value': '62.4', 'groupId': 'OG004'}, {'value': '55.1', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.5', 'ciLowerLimit': '20.7', 'ciUpperLimit': '42.2', 'pValueComment': 'P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.5', 'ciLowerLimit': '10.5', 'ciUpperLimit': '40.5', 'pValueComment': 'P-value adjusted for baseline antibiotic use (Y/N).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.1', 'ciLowerLimit': '22.8', 'ciUpperLimit': '53.3', 'pValueComment': 'P-value adjusted for baseline antibiotic use (Y/N).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 12', 'description': 'HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Baseline Hurley Stage II', 'description': 'Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks'}, {'id': 'OG001', 'title': 'Every Week (EW) - Baseline Hurley Stage II', 'description': 'Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.5', 'ciLowerLimit': '4.7', 'ciUpperLimit': '34.2', 'pValueComment': 'P-value adjusted for baseline antibiotics use (Y/N).', 'groupDescription': 'Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 12', 'description': 'The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population with baseline Hurley Stage II'}, {'type': 'SECONDARY', 'title': "Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - Baseline NRS at Worst ≥ 3', 'description': "Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive placebo every week (ew) for 12 weeks."}, {'id': 'OG001', 'title': 'Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3', 'description': "Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks)."}], 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000'}, {'value': '45.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.1', 'ciLowerLimit': '12.7', 'ciUpperLimit': '37.6', 'pValueComment': 'P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).', 'groupDescription': 'Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) up to Week 12', 'description': 'The Patient\'s Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient\'s Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population with baseline NRS at Worst ≥ 3'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Modified Sartorius Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo for 12 weeks'}, {'id': 'OG001', 'title': 'Adalimumab Every Week (EW)', 'description': 'Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.5', 'spread': '3.84', 'groupId': 'OG000'}, {'value': '-28.9', 'spread': '3.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.4', 'ciLowerLimit': '-28.6', 'ciUpperLimit': '-10.1', 'pValueComment': 'P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.', 'groupDescription': 'Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) and Week 12', 'description': 'The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo for 12 weeks'}, {'id': 'FG001', 'title': 'Adalimumab Every Week (EW)', 'description': 'Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).'}, {'id': 'FG002', 'title': 'Placebo/Placebo', 'description': 'Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).'}, {'id': 'FG003', 'title': 'Adalimumab Every Week (EW)/Placebo', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).'}, {'id': 'FG004', 'title': 'Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).'}, {'id': 'FG005', 'title': 'Adalimumab Every Week (EW)/Adalimumab Every Week (EW)', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '151'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '53'}, {'groupId': 'FG005', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '111'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Loss/absence of response (per protocol)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants ≥ 18 years of age with HS for at least 1 year prior to Baseline and HS lesions present in at least 2 distinct anatomical areas (one of which must be at least Hurley Stage II or III) who had experienced inadequate response to ≥ 90 day treatment of oral antibiotics for HS were eligible for enrolment in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo for 12 weeks'}, {'id': 'BG001', 'title': 'Adalimumab Every Week (EW)', 'description': 'Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '12.18', 'groupId': 'BG000'}, {'value': '34.9', 'spread': '9.96', 'groupId': 'BG001'}, {'value': '35.5', 'spread': '11.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2015-04-28', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-08', 'studyFirstSubmitDate': '2011-11-07', 'dispFirstSubmitQcDate': '2015-04-28', 'resultsFirstSubmitDate': '2015-09-16', 'studyFirstSubmitQcDate': '2011-11-07', 'dispFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-15', 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12', 'timeFrame': 'Baseline (Week 0) up to Week 12', 'description': 'HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12', 'timeFrame': 'Baseline (Week 0) up to Week 12', 'description': 'The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.'}, {'measure': "Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3", 'timeFrame': 'Baseline (Week 0) up to Week 12', 'description': 'The Patient\'s Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient\'s Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders.'}, {'measure': 'Change From Baseline to Week 12 in Modified Sartorius Score', 'timeFrame': 'Baseline (Week 0) and Week 12', 'description': 'The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['placebo controlled', 'double blind', 'adalimumab', 'TNF', 'psoriasis', 'HS', 'PIONEER II', 'hidradenitis suppurativa', 'acne inversa', 'boil', 'acne'], 'conditions': ['Hidradenitis Suppurativa (HS)']}, 'referencesModule': {'references': [{'pmid': '27518661', 'type': 'RESULT', 'citation': 'Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370.'}, {'pmid': '39141589', 'type': 'DERIVED', 'citation': 'Kearney N, Chen X, Bi Y, Hew K, Smith KM, Kirby B. Treatment of hidradenitis suppurativa with adalimumab in the PIONEER I and II randomized controlled trials reduced indices of systemic inflammation, recognized risk factors for cardiovascular disease. Clin Exp Dermatol. 2025 Jan 27;50(2):339-347. doi: 10.1093/ced/llae324.'}, {'pmid': '29380251', 'type': 'DERIVED', 'citation': 'Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).', 'detailedDescription': 'The clinical trial identifier is PIONEER II. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe HS. HS is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. In this study, approximately 300 adults will be enrolled at treatment centers worldwide. Subject participation in this study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. Study visits occur at Screening, Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before Week 36). The study is divided into two treatment periods. The first period (Period A) will last 12 weeks and the second period (Period B) will last 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults must have a diagnosis of HS for at least 1 year prior to Baseline.\n* HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.\n* Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.\n* Subject must have experienced an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of HS.\n* Subject must have a total AN count of greater than or equal to 3 at baseline.\n\nExclusion Criteria:\n\n* Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).\n* Subjects on permitted oral antibiotic treatment for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit.\n* Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.\n* If entering the study on concomitant oral analgesics for non-HS related pain:\n\n * Subject on opioid analgesics within 14 days prior to Baseline visit;\n * Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).'}, 'identificationModule': {'nctId': 'NCT01468233', 'acronym': 'PIONEER II', 'briefTitle': 'Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II', 'orgStudyIdInfo': {'id': 'M11-810'}, 'secondaryIdInfos': [{'id': '2011-003406-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 12 weeks.', 'interventionNames': ['Biological: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab Every Week (EW)', 'description': 'Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).', 'interventionNames': ['Biological: adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Placebo', 'description': 'Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).', 'interventionNames': ['Biological: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab Every Week (EW)/Placebo', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).', 'interventionNames': ['Biological: adalimumab', 'Biological: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).', 'interventionNames': ['Biological: adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab Every Week (EW)/Adalimumab Every Week (EW)', 'description': 'Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).', 'interventionNames': ['Biological: adalimumab']}], 'interventions': [{'name': 'adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Humira'], 'description': 'Adalimumab pre-filled syringe, administered by subcutaneous injection', 'armGroupLabels': ['Adalimumab Every Week (EW)', 'Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)', 'Adalimumab Every Week (EW)/Adalimumab Every Week (EW)', 'Adalimumab Every Week (EW)/Placebo']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo pre-filled syringe, administered by subcutaneous injection', 'armGroupLabels': ['Adalimumab Every Week (EW)/Placebo', 'Placebo', 'Placebo/Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Martin Okun, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}