Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03926195
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2019-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Bosnia and Herzegovina'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D000844', 'term': 'Ankylosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584571', 'term': 'GLPG0634'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@glpg.com', 'phone': '+32 15 342 900', 'title': 'Galapagos Medical Information', 'organization': 'Galapagos NV'}, 'certainAgreement': {'otherDetails': 'The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose up to Week 156. TEAEs were considered as AEs with onset on or after the first dose of study drug to the last dose + 30 days. AEs leading to premature discontinuation study drug was also a TEAE.', 'description': 'The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug. The Extension Phase Safety Analysis Set included all participants who took ≥ 1 dose of open-label filgotinib or standard of care in the extension phase of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Double-Blind Phase: Filgotinib 200 mg', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 12, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 10, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Extension Phase: Placebo - SOC', 'description': 'At Week 13, participants were unblinded and started SOC treatment in the EXT phase, for up to approximately 143 weeks (until Week 156).', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 23, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Extension Phase: Filgotinib 200 mg - SOC', 'description': 'At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase, for up to approximately 143 weeks (until Week 156).', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Extension Phase: Filgotinib 200 mg - OL Filgotinib 200 mg', 'description': 'At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily in the EXT phase, for up to approximately 143 weeks (until Week 156).', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 20, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'External ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Splenic artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Renal aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ankylosing spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Herpes zoster disseminated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgonitib', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '19.2', 'estimateComment': 'Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 13', 'description': 'Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL.\n\nPercentage change = (\\[mean at Week 13 - baseline\\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Semen Analysis Set included all randomized and treated (≥ 1 dose of double-blind study drug) participants who had 2 semen samples that were eligible for mean calculation at baseline and at the Week 13 analysis visit with the date of the first chronologic semen sample used for purposes of assigning analysis visit windows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib/OL Filgotinib (Responder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase.'}, {'id': 'OG001', 'title': 'Placebo/SOC (Responder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG002', 'title': 'Filgotinib/SOC (Nonresponder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG003', 'title': 'Placebo/SOC (Nonresponder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 26', 'description': "Arthritis responder: For rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nrAxSpA), a participant with an improvement in the Physician's Global Assessment of Disease Activity (PhGADA) of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a visual analogue scale (VAS) ranged from 0 (no disease)-100 (worst disease) millimeters (mm).\n\nBaseline value for sperm/semen parameters was the mean of 2 evaluable semen collections at the screening visit. The normal range for sperm concentration is ≥15 million sperms/mL.\n\nPercentage change = (\\[mean at Week 26 - baseline\\] / baseline) × 100; value at Week 26 was the mean of 2 evaluable samples collected at Week 26.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Week 26 Semen Analysis Set included all participants treated (≥ 1 dose of open-label filgotinib or SOC in the extension phase) who had 2 evaluable samples at baseline and at Week 26.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sperm Total Motility at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgonitib', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-8.1', 'upperLimit': '1.4'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-5.8', 'upperLimit': '0.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '3.5', 'estimateComment': 'Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for sperm total motility is ≥40%.', 'unitOfMeasure': 'percentage of motile sperms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Semen Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sperm Total Motility at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib/OL Filgotinib (Responder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase.'}, {'id': 'OG001', 'title': 'Placebo/SOC (Responder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG002', 'title': 'Filgotinib/SOC (Nonresponder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG003', 'title': 'Placebo/SOC (Nonresponder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-9.3', 'upperLimit': '1.0'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '6.3'}, {'value': '-1.4', 'groupId': 'OG002', 'lowerLimit': '-13.3', 'upperLimit': '13.0'}, {'value': '-2.8', 'groupId': 'OG003', 'lowerLimit': '-8.5', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for sperm total motility is ≥40%.", 'unitOfMeasure': 'percentage of motile sperms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Week 26 Semen Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Sperm Count at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgonitib', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-41.7', 'upperLimit': '31.0'}, {'value': '-9.6', 'groupId': 'OG001', 'lowerLimit': '-36.2', 'upperLimit': '18.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-37.1', 'ciUpperLimit': '36.8', 'estimateComment': 'Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for total sperm count is ≥ 39 million sperms/ejaculate.', 'unitOfMeasure': 'million sperms/ejaculate', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Semen Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Sperm Count at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib/OL Filgotinib (Responder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase.'}, {'id': 'OG001', 'title': 'Placebo/SOC (Responder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG002', 'title': 'Filgotinib/SOC (Nonresponder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG003', 'title': 'Placebo/SOC (Nonresponder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-39.5', 'upperLimit': '44.5'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '-49.3', 'upperLimit': '60.6'}, {'value': '32.2', 'groupId': 'OG002', 'lowerLimit': '-60.8', 'upperLimit': '121.3'}, {'value': '-29.9', 'groupId': 'OG003', 'lowerLimit': '-79.8', 'upperLimit': '36.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for total sperm count is ≥ 39 million sperms/ejaculate.", 'unitOfMeasure': 'million sperms/ejaculate', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Week 26 Semen Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sperm Concentration at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgonitib', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '-7.2', 'upperLimit': '13.1'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-6.1', 'upperLimit': '7.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.4', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '20.8', 'estimateComment': 'Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for sperm concentration is ≥15 million sperms/mL.', 'unitOfMeasure': 'million sperms/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Semen Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sperm Concentration at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib/OL Filgotinib (Responder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase.'}, {'id': 'OG001', 'title': 'Placebo/SOC (Responder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG002', 'title': 'Filgotinib/SOC (Nonresponder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG003', 'title': 'Placebo/SOC (Nonresponder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '-8.9', 'upperLimit': '21.2'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '-3.7', 'upperLimit': '29.0'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '-43.5', 'upperLimit': '36.3'}, {'value': '-5.8', 'groupId': 'OG003', 'lowerLimit': '-12.9', 'upperLimit': '4.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for sperm concentration is ≥15 million sperms/mL.", 'unitOfMeasure': 'million sperms/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Week 26 Semen Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ejaculate Volume at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgonitib', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '0.1'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.1', 'estimateComment': 'Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for ejaculate volume is ≥1.5 mL.', 'unitOfMeasure': 'mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Semen Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ejaculate Volume at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib/OL Filgotinib (Responder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase.'}, {'id': 'OG001', 'title': 'Placebo/SOC (Responder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG002', 'title': 'Filgotinib/SOC (Nonresponder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG003', 'title': 'Placebo/SOC (Nonresponder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '0.4'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.2'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '1.1'}, {'value': '-0.3', 'groupId': 'OG003', 'lowerLimit': '-0.6', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for ejaculate volume is ≥1.5 mL.", 'unitOfMeasure': 'mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Week 26 Semen Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Normal Sperm Morphology at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgonitib', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-3', 'ciUpperLimit': '1', 'estimateComment': 'Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for percent normal sperm morphology is ≥30% normal sperms.', 'unitOfMeasure': 'percentage of normal sperms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Semen Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Normal Sperm Morphology at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib/OL Filgotinib (Responder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase.'}, {'id': 'OG001', 'title': 'Placebo/SOC (Responder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG002', 'title': 'Filgotinib/SOC (Nonresponder)', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}, {'id': 'OG003', 'title': 'Placebo/SOC (Nonresponder)', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis nonresponders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '8'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '-15', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for percent normal sperm morphology is ≥30% normal sperms.", 'unitOfMeasure': 'percentage of normal sperms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Week 26 Semen Analysis Set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Filgonitib', 'description': 'Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.'}], 'periods': [{'title': 'DB Treatment Phase (Through Week 13)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'EXT Phase (Through Week 156)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '39 arthritis responder participants entered the EXT phase and received OL treatment filgotinib. 7 arthritis nonresponder participants entered the EXT phase and received SOC treatment.', 'groupId': 'FG000', 'numSubjects': '46'}, {'comment': '26 arthritis responder participants and 23 arthritis nonresponder participants entered the EXT phase and received SOC treatment.', 'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pre-Specified Decrease In Sperm Parameters', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Monitoring Phase (52 Weeks)', 'milestones': [{'type': 'STARTED', 'comment': 'At any visit, participants who had a ≥50% decrease in sperm concentration, and/or sperm motility, and/or sperm morphology compared with baseline entered the Monitoring Phase for evaluation of reversibility.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Bulgaria, Czech Republic, Estonia, Georgia, Latvia, Poland, Spain, and Ukraine. The first participant was screened on 28 May 2019. A total of 308 participants were screened of which 109 participants were randomized into the study.', 'preAssignmentDetails': 'There were 3 distinct parts to the study:\n\n1\\) Double-Blind Treatment Phase (DB Phase; Day 1 through the Week 13 study visit); 2) Extension Phase (EXT Phase; after the Week 13 study visit and up to Week 156); and 3) Monitoring Phase (up to 52 weeks).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Filgonitib', 'description': 'Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '39', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '40', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sperm Concentration', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '41.00', 'groupId': 'BG000'}, {'value': '66.9', 'spread': '38.72', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '39.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'million sperms/milliliter (mL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Sperm Count', 'classes': [{'categories': [{'measurements': [{'value': '208.4', 'spread': '136.94', 'groupId': 'BG000'}, {'value': '225.2', 'spread': '137.39', 'groupId': 'BG001'}, {'value': '216.9', 'spread': '136.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'million sperms/ejaculate', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sperm Total Motility', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '8.99', 'groupId': 'BG000'}, {'value': '58.2', 'spread': '8.48', 'groupId': 'BG001'}, {'value': '57.1', 'spread': '8.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of motile sperm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ejaculate Volume', 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '1.26', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '1.29', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '1.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent Normal Sperm Morphology', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '43', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '43', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of normal sperm', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-09', 'size': 12170147, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-22T10:49', 'hasProtocol': True}, {'date': '2021-01-12', 'size': 8794829, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-26T03:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2021-07-27', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2019-04-19', 'resultsFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2019-04-19', 'dispFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-13', 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13', 'timeFrame': 'Baseline to Week 13', 'description': 'Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL.\n\nPercentage change = (\\[mean at Week 13 - baseline\\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26', 'timeFrame': 'Baseline to Week 26', 'description': "Arthritis responder: For rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nrAxSpA), a participant with an improvement in the Physician's Global Assessment of Disease Activity (PhGADA) of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a visual analogue scale (VAS) ranged from 0 (no disease)-100 (worst disease) millimeters (mm).\n\nBaseline value for sperm/semen parameters was the mean of 2 evaluable semen collections at the screening visit. The normal range for sperm concentration is ≥15 million sperms/mL.\n\nPercentage change = (\\[mean at Week 26 - baseline\\] / baseline) × 100; value at Week 26 was the mean of 2 evaluable samples collected at Week 26."}, {'measure': 'Change From Baseline in Sperm Total Motility at Week 13', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for sperm total motility is ≥40%.'}, {'measure': 'Change From Baseline in Sperm Total Motility at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for sperm total motility is ≥40%."}, {'measure': 'Change From Baseline in Total Sperm Count at Week 13', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for total sperm count is ≥ 39 million sperms/ejaculate.'}, {'measure': 'Change From Baseline in Total Sperm Count at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for total sperm count is ≥ 39 million sperms/ejaculate."}, {'measure': 'Change From Baseline in Sperm Concentration at Week 13', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for sperm concentration is ≥15 million sperms/mL.'}, {'measure': 'Change From Baseline in Sperm Concentration at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for sperm concentration is ≥15 million sperms/mL."}, {'measure': 'Change From Baseline in Ejaculate Volume at Week 13', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for ejaculate volume is ≥1.5 mL.'}, {'measure': 'Change From Baseline in Ejaculate Volume at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for ejaculate volume is ≥1.5 mL."}, {'measure': 'Change From Baseline in Percent Normal Sperm Morphology at Week 13', 'timeFrame': 'Baseline, Week 13', 'description': 'The normal range for percent normal sperm morphology is ≥30% normal sperms.'}, {'measure': 'Change From Baseline in Percent Normal Sperm Morphology at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.\n\nArthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.\n\nPhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.\n\nThe normal range for percent normal sperm morphology is ≥30% normal sperms."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Ankylosing Spondylitis', 'Non-Radiographical Axial Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '37137672', 'type': 'DERIVED', 'citation': 'Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, Ritter T, Seidler U, Golovchenko O, Simanenkov V, Garmish O, Jeka S, Moravcova R, Rajendran V, Le Brun FO, Arterburn S, Watkins TR, Besuyen R, Vanderschueren D. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023 Aug;82(8):1049-1058. doi: 10.1136/ard-2023-224017. Epub 2023 May 3.'}, {'pmid': '35614292', 'type': 'DERIVED', 'citation': 'Hellstrom WJG, Dolhain RJEM, Ritter TE, Watkins TR, Arterburn SJ, Dekkers G, Gillen A, Tonussi C, Gilles L, Oortwijn A, Van Beneden K, de Vries DE, Sikka SC, Vanderschueren D, Reinisch W. MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases. Adv Ther. 2022 Jul;39(7):3403-3422. doi: 10.1007/s12325-022-02168-4. Epub 2022 May 25.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.\n\nResults of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the same objective.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening, meeting the corresponding specific disease classification criteria as specified in the protocol\n\nKey Exclusion Criteria:\n\n* Previously documented problems with male reproductive health\n* Prior diagnosis of male infertility\n* Use of any prohibited concomitant medication as outlined by protocol\n\nNote: Other protocol-defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03926195', 'acronym': 'MANTA-RAy', 'briefTitle': 'Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis', 'orgStudyIdInfo': {'id': 'GLPG0634-CL-227'}, 'secondaryIdInfos': [{'id': '2018-003933-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Filgotinib', 'description': 'Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks.', 'interventionNames': ['Drug: Filgotinib', 'Drug: Standard of Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.', 'interventionNames': ['Drug: Placebo', 'Drug: Standard of Care']}], 'interventions': [{'name': 'Filgotinib', 'type': 'DRUG', 'otherNames': ['GS-6034', 'Jyseleca®'], 'description': '200-mg tablet administered orally once daily', 'armGroupLabels': ['Filgotinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match filgotinib tablet administered orally once daily', 'armGroupLabels': ['Placebo']}, {'name': 'Standard of Care', 'type': 'DRUG', 'description': 'Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.', 'armGroupLabels': ['Filgotinib', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Medical center Medconsult Pleven OOD', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'UMHAT Pulmed OOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'UMHAT Sv. Georgi, EAD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'MHAT "Eurohospital" - Plovdiv, OOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7000', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Medical Center Teodora, EOOD', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '5400', 'city': 'Sevlievo', 'country': 'Bulgaria', 'facility': 'Medizinski Zentar-1-Sevlievo EOOD', 'geoPoint': {'lat': 43.02295, 'lon': 25.10364}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Center Excelsior, OOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'DCC Alexandrovska, EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT Sv. Ivan Rilski, EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1504', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'DCC 17 - Sofia EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Meditsinski Centar - Izgrev EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1784', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MC Synexus - Sofia, EOOD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '60200', 'city': 'Brno', 'country': 'Czechia', 'facility': 'CCR Brno S.r.o.', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '702 00', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'CCBR Ostrava s.r.o', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '702 00', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Vesalion s.r.o.', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '708 00', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'MUDr. Rosypalova s.r.o.', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '530 02', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Bioclinica Pardubice', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '10000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'CLINTRIAL s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 52', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Revmatologicky Ustav', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 59', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Thomayerova nemocnice', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '14000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'MUDr Zuzana Stejfova Revmatologicka ambulance', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '14800', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Affidea Praha s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '68601', 'city': 'Uherské Hradiště', 'country': 'Czechia', 'facility': 'MEDICAL PLUS s.r.o.', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'zip': '10117', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'OÜ Innomedica', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '10128', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Center for Clinical and Basic Research', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre Foundation', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '50106', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Clinical Research Centre', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '50406', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Meditrials OU', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Chapidze Emergency Cardiology Center', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Institute of Clinical Cardiology Ltd', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'National Institute of Endocrinology', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi Heart and Vascular Clinic Ltd', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Aversi ClinicLtd.', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0179', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Clinic on Mtskheta Street', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Consilium Medulla-multiprofile clinic Ltd', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Medicore Ltd.', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': 'LV2164', 'city': 'Ādaži', 'country': 'Latvia', 'facility': 'M&M center', 'geoPoint': {'lat': 57.0708, 'lon': 24.33678}}, {'zip': '85-065', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Nasz Lekarz Osrodek Badan Klinicznych', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki nr 2 im. dr J. Biziela', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '40-282', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Silmedic sp. z o.o', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '44-190', 'city': 'Knurów', 'country': 'Poland', 'facility': 'Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla', 'geoPoint': {'lat': 50.21971, 'lon': 18.65067}}, {'zip': '91-363', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Centrum Medyczne AMED', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-607', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Zespol Poradni Specjalistycznych REUMED', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-529', 'city': 'Poznan', 'country': 'Poland', 'facility': 'SOLUMED Centrum Medyczne', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '60-773', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Centrum Badan Klinicznych S.C.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '61-113', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Ai Centrum Medyczne Sp. Z O.O. Sp.K.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '96-500', 'city': 'Sochaczew', 'country': 'Poland', 'facility': 'RCMed', 'geoPoint': {'lat': 52.22944, 'lon': 20.23838}}, {'zip': '00-874', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Medycyna Kliniczna', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '03-291', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Medyczne AMED', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '15702', 'city': 'Santiago', 'country': 'Spain', 'facility': 'Clinica GAIAS', 'geoPoint': {'lat': 37.9358, 'lon': -4.13866}}, {'zip': '49102', 'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'CI Dnipropetrovsk CMCH #4 RC', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '76008', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61039', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61124', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'CHI Kharkiv City Clinical Hospital #13', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '73000', 'city': 'Kherson', 'country': 'Ukraine', 'facility': 'CI A.and O. Tropiny City Clinical Hospital', 'geoPoint': {'lat': 46.63695, 'lon': 32.61458}}, {'zip': '01023', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Medical Center of Limited Liability Company Medical Clinic Blagomed', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '02091', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': "Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC", 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '03680', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04050', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Limited Liability Company Medical Center Concilium Medical', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04050', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'LLC Treatment-Diagnostic Center ADONIS plus', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '43005', 'city': 'Lutsk', 'country': 'Ukraine', 'facility': 'Volyn Regional Clinical Hospital', 'geoPoint': {'lat': 50.75784, 'lon': 25.35024}}, {'zip': '79000', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Lviv Regional Clinical Hospital Dept of Rheumatology NMU', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '79049', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Mil&Med Cl C of Lviv of the St Border Service of Ukraine', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '65000', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Center of Reconstructive & Restorative Medicine of Odessa National Medical University', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '36011', 'city': 'Poltava', 'country': 'Ukraine', 'facility': 'M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'zip': '46002', 'city': 'Ternopil', 'country': 'Ukraine', 'facility': 'Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU', 'geoPoint': {'lat': 49.55404, 'lon': 25.59067}}, {'zip': '21001', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Private Small Enterprise Medical Center Pulse', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21018', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '21029', 'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'MCIC Health Clinic BO LTD TDC Slaomed', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}, {'zip': '69035', 'city': 'Zaporizhzhya', 'country': 'Ukraine', 'facility': 'CI CCH #6 Dept of Therapy ZSMU', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}, {'zip': '69600', 'city': 'Zaporizhzhya', 'country': 'Ukraine', 'facility': 'CI Zaporizhzhia Regional Clinical Hospital of ZRC', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}], 'overallOfficials': [{'name': 'Galapagos Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galapagos NV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galapagos NV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}