Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-09 @ 4:00 AM
Study NCT ID:
NCT02016105
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2013-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'biopharma.clinicaltrials@sandoz.com', 'phone': '+49 8024 476', 'title': 'Global Program Medical Director', 'phoneExt': '0', 'organization': 'Sandoz'}, 'certainAgreement': {'otherDetails': 'The Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'none reported'}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)', 'eventGroups': [{'id': 'EG000', 'title': 'Humira ® Adalimumab Switched', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nHumira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 40, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 85, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'GP2017 Adalimumab Switched', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nGP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 47, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 84, 'seriousNumAtRisk': 126, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 23, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Gatroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 14, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 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'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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{'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 20, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 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'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 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'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 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'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Abdominall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 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126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP2017 Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-7.46', 'ciUpperLimit': '11.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.75', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Adjusted response rates were estimated using a logistic regression model including treatment, body weight strata, region and prior systemic therapy. The 95% CI for the rate difference was derived based on the normal approximation and standard error computed using the delta method.To conclude equivalent efficacy, the 95% CI had to be entirely within the interval \\[-18%, 18%\\].'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16 only', 'description': 'The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP2017 Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '-60.7', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-61.5', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-3.15', 'ciUpperLimit': '4.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.03', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'LS means, SE and 95% CI were estimated by a Mixed Model Repeated Measures (MMRM) model with treatment, visit, treatment-by-visit interaction, body weight strata, region and prior systemic therapy, as fixed factors and baseline PASI score as covariate.\n\nTherapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira treatment was contained within the interval \\[-15%; 15%\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.'}, {'type': 'SECONDARY', 'title': 'Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP2017 Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '-59.7', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '60.8', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS means difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-2.78', 'ciUpperLimit': '5.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.0', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'LSM, SE and 95% CI were estimated using an ANCOVA model with treatment, body weight strata, region and prior systemic therapy as fixed effects and baseline PASI score as covariate. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira was contained within the interval \\[-15%; 15%\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.'}, {'type': 'SECONDARY', 'title': 'PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP2017 Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}], 'classes': [{'title': '% of patients achieving PASI50 at Week 17', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000'}, {'value': '92.8', 'groupId': 'OG001'}]}]}, {'title': '% of patients achieving PASI75 at Week 17', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '68.6', 'groupId': 'OG001'}]}]}, {'title': '% of patients achieving PASI90 at Week 17', 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}]}]}, {'title': '% of patients achieving PASI100 at Week 17', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '16.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 17 only', 'description': 'Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.'}, {'type': 'SECONDARY', 'title': 'PASI 50, PASI75, PASI 90 and PASI100 Response Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira ® Adalimumab Switched', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nHumira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}, {'id': 'OG002', 'title': 'GP2017 Adalimumab Switched', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nGP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG003', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}], 'classes': [{'title': '% of patients achieving PASI50 at Week 35', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000'}, {'value': '96.4', 'groupId': 'OG001'}, {'value': '94.1', 'groupId': 'OG002'}, {'value': '96.1', 'groupId': 'OG003'}]}]}, {'title': '% of patients achieving PASI75 at Week 35', 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}, {'value': '73.6', 'groupId': 'OG001'}, {'value': '70.6', 'groupId': 'OG002'}, {'value': '74.5', 'groupId': 'OG003'}]}]}, {'title': '% of patients achieving PASI90 at Week 35', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}, {'value': '52.7', 'groupId': 'OG001'}, {'value': '62.7', 'groupId': 'OG002'}, {'value': '61.8', 'groupId': 'OG003'}]}]}, {'title': '% of patients achieving PASI100 at Week 35', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '30.9', 'groupId': 'OG001'}, {'value': '35.3', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 35 only', 'description': 'Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PASI 50, PASI75, PASI 90 and PASI100 Response Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira ® Adalimumab Switched', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nHumira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}, {'id': 'OG002', 'title': 'GP2017 Adalimumab Switched', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nGP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG003', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}], 'classes': [{'title': '% of patients achieving PASI50 at Week 51', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}, {'value': '93.9', 'groupId': 'OG001'}, {'value': '87.5', 'groupId': 'OG002'}, {'value': '95.9', 'groupId': 'OG003'}]}]}, {'title': '% of patients achieving PASI75 at Week 51', 'categories': [{'measurements': [{'value': '76.7', 'groupId': 'OG000'}, {'value': '79.6', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}, {'value': '84.5', 'groupId': 'OG003'}]}]}, {'title': '% of patients achieving PASI90 at Week 51', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '51.0', 'groupId': 'OG001'}, {'value': '60.4', 'groupId': 'OG002'}, {'value': '62.9', 'groupId': 'OG003'}]}]}, {'title': '% of patients achieving PASI100 at Week 51', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}, {'value': '31.3', 'groupId': 'OG002'}, {'value': '35.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 51 only', 'description': 'Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IGA Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP2017 Adalimumab', 'description': 'Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.\n\nGP2017 Adalimumab'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab', 'description': 'Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.\n\nHumira ® Adalimumab'}], 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}, {'value': '53.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 17 only', 'description': 'Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 17.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.'}, {'type': 'SECONDARY', 'title': 'IGA Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira ® Adalimumab Switched', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nHumira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}, {'id': 'OG002', 'title': 'GP2017 Adalimumab Switched', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nGP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG003', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000'}, {'value': '58.2', 'groupId': 'OG001'}, {'value': '58.8', 'groupId': 'OG002'}, {'value': '58.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 35 only', 'description': 'Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IGA Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira ® Adalimumab Switched', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nHumira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}, {'id': 'OG002', 'title': 'GP2017 Adalimumab Switched', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nGP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG003', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000'}, {'value': '55.1', 'groupId': 'OG001'}, {'value': '58.3', 'groupId': 'OG002'}, {'value': '59.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 51 only', 'description': 'Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DLQI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP2017 Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000'}, {'value': '48.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 17 only', 'description': "Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)", 'unitOfMeasure': '% of patients with DLQI of 0 or 1', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.'}, {'type': 'SECONDARY', 'title': 'DLQI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira ® Adalimumab Switched', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nHumira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}, {'id': 'OG002', 'title': 'GP2017 Adalimumab Switched', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nGP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG003', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}, {'value': '52.9', 'groupId': 'OG002'}, {'value': '55.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 35 only', 'description': "Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)", 'unitOfMeasure': '% of patients with DLQI of 0 or 1', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DLQI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira ® Adalimumab Switched', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nHumira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}, {'id': 'OG002', 'title': 'GP2017 Adalimumab Switched', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nGP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG003', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}, {'value': '54.2', 'groupId': 'OG002'}, {'value': '59.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 51 only', 'description': "Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)", 'unitOfMeasure': '% of patients with DLQI of 0 or 1', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GP2017 Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}], 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 17 only', 'description': 'Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17.\n\nPatients with ADA positive results at baseline were excluded from subsequent results.', 'unitOfMeasure': '% patients with at least 1 ADA+ sample', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.'}, {'type': 'SECONDARY', 'title': 'ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira ® Adalimumab Switched', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nHumira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG001', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}, {'id': 'OG002', 'title': 'GP2017 Adalimumab Switched', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).\n\nGP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'OG003', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}, {'value': '46.7', 'groupId': 'OG002'}, {'value': '35.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 51 only', 'description': 'Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51.\n\nPatients with ADA positive results at baseline were excluded from subsequent results.', 'unitOfMeasure': '% patients with at least 1 ADA+ sample', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GP2017 Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'FG001', 'title': 'Humira ® Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'FG002', 'title': 'Humira ® Adalimumab Switched', 'description': 'Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'FG003', 'title': 'Humira ® Adalimumab Continued', 'description': 'Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).'}, {'id': 'FG004', 'title': 'GP2017 Adalimumab Switched', 'description': 'Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).'}, {'id': 'FG005', 'title': 'GP2017 Adalimumab Continued', 'description': 'GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).'}], 'periods': [{'title': 'TREATMENT PERIOD 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '234'}, {'comment': 'Treatment arm applicable only in Treatment Period 2 and Extension Period', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Treatment arm applicable only in Treatment Period 2 and Extension Period', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Treatment arm applicable only in Treatment Period 2 and Extension Period', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Treatment arm applicable only in Treatment Period 2 and Extension Period', 'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '12 patients did not proceed into Treatment Period 2', 'groupId': 'FG000', 'numSubjects': '201'}, {'comment': '11 patients did not proceed into Treatment Period 2', 'groupId': 'FG001', 'numSubjects': '201'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'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': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'TREATMENT PERIOD 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Treatment arm applicable for Treatment Period 1 only (patients re-randomized in Treatment Period 2)', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Treatment arm applicable for Treatment Period 1 only (patients re-randomized in Treatment Period 2)', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Patients re-randomized from "Humira ® adalimumab" treatment arm in Treatment Period 1', 'groupId': 'FG002', 'numSubjects': '63'}, {'comment': 'Patients re-randomized from "Humira ® adalimumab" treatment arm in Treatment Period 1', 'groupId': 'FG003', 'numSubjects': '127'}, {'comment': 'Patients re-randomized from "GP2017 adalimumab" treatment arm in Treatment Period 1', 'groupId': 'FG004', 'numSubjects': '63'}, {'comment': 'Patients re-randomized from "GP2017 adalimumab" treatment arm in Treatment Period 1', 'groupId': 'FG005', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '116'}, {'groupId': 'FG004', 'numSubjects': '59'}, {'groupId': 'FG005', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Non compliance study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'EXTENSION PERIOD', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '5 patients did not proceed from Treatment Period 2 into Extension Period', 'groupId': 'FG002', 'numSubjects': '52'}, {'comment': '7 patients did not proceed from Treatment Period 2 into Extension Period', 'groupId': 'FG003', 'numSubjects': '109'}, {'comment': '3 patients did not proceed from Treatment Period 2 into Extension Period', 'groupId': 'FG004', 'numSubjects': '56'}, {'comment': '6 patients did not proceed from Treatment Period 2 into Extension Period', 'groupId': 'FG005', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '104'}, {'groupId': 'FG004', 'numSubjects': '50'}, {'groupId': 'FG005', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'New therapy for study indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study indication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '661 patients were screened. 465 patients were randomized 1:1 into Treatment Period 1 and stratified by region (US/EU), body weight (\\<90/≥90 kg) and prior systemic therapy (no/any). In Treatment Period 2 patients were re-randomized 2:1 to either continue originally assigned treatment or switch treatment and were stratified by region only.', 'preAssignmentDetails': 'Screening lasted for at least 2 weeks and up to 4 weeks. Main inclusion criteria:\n\n* Men or women of at least 18 years\n* Chronic plaque-type psoriasis ≥ 6 months before randomization\n* Moderate to severe psoriasis :\n\n * PASI score ≥ 12\n * IGA score ≥3\n * BSA affected by plaque-type psoriasis ≥ 10%\n* No previous exposure to adalimumab'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GP2017 Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'BG001', 'title': 'Humira ® Adalimumab', 'description': 'Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.6', 'spread': '14.16', 'groupId': 'BG000'}, {'value': '46.9', 'spread': '14.09', 'groupId': 'BG001'}, {'value': '46.3', 'spread': '14.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The Full analysis set (FAS) consists of all randomized patients to whom a study treatment was assigned.'}}, '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': 465}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'dispFirstSubmitDate': '2016-03-08', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2013-12-14', 'dispFirstSubmitQcDate': '2016-03-08', 'resultsFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2013-12-14', 'dispFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-22', 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab', 'timeFrame': 'At Week 16 only', 'description': 'The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)', 'timeFrame': 'Baseline to Week 16', 'description': 'The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.'}, {'measure': 'Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)', 'timeFrame': 'Baseline to Week 16', 'description': 'The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).'}, {'measure': 'PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates', 'timeFrame': 'At Week 17 only', 'description': 'Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)'}, {'measure': 'PASI 50, PASI75, PASI 90 and PASI100 Response Rates', 'timeFrame': 'At Week 35 only', 'description': 'Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)'}, {'measure': 'PASI 50, PASI75, PASI 90 and PASI100 Response Rates', 'timeFrame': 'At Week 51 only', 'description': 'Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)'}, {'measure': 'IGA Response Rate', 'timeFrame': 'At Week 17 only', 'description': 'Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 17.'}, {'measure': 'IGA Response Rate', 'timeFrame': 'At Week 35 only', 'description': 'Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51'}, {'measure': 'IGA Response Rate', 'timeFrame': 'At Week 51 only', 'description': 'Proportion of patients achieving a score of 0 ("clear") or 1 ("almost clear") or improved by at least 2 points of the IGA scale compared to baseline at Week 51'}, {'measure': 'DLQI', 'timeFrame': 'At Week 17 only', 'description': "Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)"}, {'measure': 'DLQI', 'timeFrame': 'At Week 35 only', 'description': "Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)"}, {'measure': 'DLQI', 'timeFrame': 'At Week 51 only', 'description': "Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)"}, {'measure': 'ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17', 'timeFrame': 'At Week 17 only', 'description': 'Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17.\n\nPatients with ADA positive results at baseline were excluded from subsequent results.'}, {'measure': 'ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51', 'timeFrame': 'At Week 51 only', 'description': 'Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51.\n\nPatients with ADA positive results at baseline were excluded from subsequent results.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['plaque type psoriasis', 'equivalent efficacy', 'safety and immunogenicity', 'GP2017', 'Humira®'], 'conditions': ['Plaque Type Psoriasis']}, 'referencesModule': {'references': [{'pmid': '39545451', 'type': 'DERIVED', 'citation': 'Lemke L, Blauvelt A, Bruckmann I, Cohen HP, Fan J, Guerrieri D, Horvat M, Poetzl J, Torella C, Wang Q, von Richter O. Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies. Expert Opin Biol Ther. 2024 Dec;24(12):1375-1385. doi: 10.1080/14712598.2024.2428299. Epub 2024 Nov 19.'}, {'pmid': '33651341', 'type': 'DERIVED', 'citation': 'Blauvelt A, Leonardi CL, Gaylis N, Jauch-Lembach J, Balfour A, Lemke L, Hachaichi S, Brueckmann I, Festini T, Wiland P. Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS). BioDrugs. 2021 Mar;35(2):229-238. doi: 10.1007/s40259-021-00470-1. Epub 2021 Mar 2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.', 'detailedDescription': 'The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.\n\nThe subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women at least 18 years of age at time of screening\n* Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization\n* Moderate to severe psoriasis as defined at baseline by:\n\n * PASI score of 12 or greater\n * Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,\n * Body Surface Area affected by plaque-type psoriasis of 10% or greater\n* Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Forms of psoriasis other than chronic plaque-type\n* Drug-induced psoriasis\n* Ongoing use of prohibited psoriasis treatments\n* Previous exposure to adalimumab\n* Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab\n\nOther In-/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02016105', 'acronym': 'ADACCESS', 'briefTitle': 'Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis', 'orgStudyIdInfo': {'id': 'GP17-301'}, 'secondaryIdInfos': [{'id': '2013-000747-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GP2017 Adalimumab', 'description': 'Study arm with intervention being studied in the protocol. 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