Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT02518620
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606096', 'term': 'ALX-0061'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@ablynx.com', 'phone': '+32 (0)9 262 00 00', 'title': 'Medical Monitor', 'organization': 'Ablynx NV'}, 'certainAgreement': {'otherDetails': 'Publication of any results from this study will be according to the principles of the Declaration of Helsinki, in particular point 30, and will require prior review and written agreement of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.", 'eventGroups': [{'id': 'EG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg s.c. q2w + MTX', 'otherNumAtRisk': 257, 'deathsNumAtRisk': 257, 'otherNumAffected': 122, 'seriousNumAtRisk': 257, 'deathsNumAffected': 2, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg s.c. q2w', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 96, 'seriousNumAtRisk': 148, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Total', 'description': 'C203 All Subjects', 'otherNumAtRisk': 405, 'deathsNumAtRisk': 405, 'otherNumAffected': 218, 'seriousNumAtRisk': 405, 'deathsNumAffected': 2, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 44, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 35, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 29, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypercholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 28, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 23, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 51, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Retroperitoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Testicular seminoma (pure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '406', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg q2w + MTX'}, {'id': 'OG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg q2w'}, {'id': 'OG002', 'title': 'Total (C203 All Subjects)', 'description': 'C203 All Subjects'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '400', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '350', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '387', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '310', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': "ACR 20 response is defined as:\n\n* 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND\n* 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND\n* 20% improvement in 3 of the following 5 areas relative to Week 0:\n\n * Subject's Assessment of Pain (100 mm - visual analogue scale \\[VAS\\])\n * Subject's Global Assessment of Disease Activity (VASPA)\n * Physician's Global Assessment of Disease Activity (VASPHA)\n * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)\n * C-reactive protein (CRP) level\n\nACR20 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITO Population'}, {'type': 'PRIMARY', 'title': 'Number and Percentage of Subjects With ACR50 Response.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '406', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg q2w + MTX'}, {'id': 'OG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg q2w'}, {'id': 'OG002', 'title': 'Total (C203 All Subjects)', 'description': 'C203 All Subjects'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '394', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '356', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '321', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': "ACR50 response is defined as:\n\n* 50% improvement in TJC (68 joints) relative to Week 0 AND\n* 50% improvement in SJC (66 joints) relative to Week 0 AND\n* 50% improvement in 3 of the following 5 areas relative to Week 0:\n\n * Subject's Assessment of Pain (100 mm - VAS)\n * Subject's Global Assessment of Disease Activity (VASPA)\n * Physician's Global Assessment of Disease Activity (VASPHA)\n * Subject's assessment of physical function as measured by HAQ-DI\n * CRP level\n\nACR50 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITO Population'}, {'type': 'PRIMARY', 'title': 'Number and Percentage of Subjects With ACR70 Response.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '406', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg q2w + MTX'}, {'id': 'OG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg q2w'}, {'id': 'OG002', 'title': 'Total (C203 All Subjects)', 'description': 'C203 All Subjects'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '396', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '354', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': "ACR70 response is defined as:\n\n* 70% improvement in TJC (68 joints) relative to Week 0 AND\n* 70% improvement in SJC (66 joints) relative to Week 0 AND\n* 70% improvement in 3 of the following 5 areas relative to Week 0:\n\n * Subject's Assessment of Pain (100 mm - VAS)\n * Subject's Global Assessment of Disease Activity (VASPA)\n * Physician's Global Assessment of Disease Activity (VASPHA)\n * Subject's assessment of physical function as measured by HAQ-DI\n * CRP level\n\nACR70 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITO Population'}, {'type': 'PRIMARY', 'title': 'ACR-N Index of Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '406', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg q2w + MTX'}, {'id': 'OG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg q2w'}, {'id': 'OG002', 'title': 'Total (C203 All Subjects)', 'description': 'C203 All Subjects'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '405', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.77', 'spread': '1.703', 'groupId': 'OG000'}, {'value': '48.18', 'spread': '2.171', 'groupId': 'OG001'}, {'value': '52.98', 'spread': '1.351', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '394', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.51', 'spread': '1.643', 'groupId': 'OG000'}, {'value': '57.07', 'spread': '2.181', 'groupId': 'OG001'}, {'value': '59.91', 'spread': '1.315', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '363', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67.73', 'spread': '1.691', 'groupId': 'OG000'}, {'value': '66.49', 'spread': '2.048', 'groupId': 'OG001'}, {'value': '67.27', 'spread': '1.306', 'groupId': 'OG002'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.83', 'spread': '1.554', 'groupId': 'OG000'}, {'value': '73.82', 'spread': '2.171', 'groupId': 'OG001'}, {'value': '74.45', 'spread': '1.265', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': "The ACR-N Index of Improvement is defined as the minimum of the following 3 criteria:\n\n* The percent improvement from Week 0 in TJCs\n* The percent improvement from Week 0 in SJCs\n* The median percent improvement from Week 0 for the following 5 assessments:\n\n * Subject's assessment of pain (VAS)\n * Subject's global assessment of disease activity (VASPHA)\n * Physician's global assessment of disease activity (VASPHA)\n * Subject's assessment of physical function as measured by the HAQ-DI\n * CRP level\n\nACR-N Index of Improvement was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.", 'unitOfMeasure': 'percent improvement', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITO Population'}, {'type': 'PRIMARY', 'title': 'Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '406', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg q2w + MTX'}, {'id': 'OG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg q2w'}, {'id': 'OG002', 'title': 'Total (C203 All Subjects)', 'description': 'C203 All Subjects'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '401', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}, {'title': 'Low Disease Activity', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}, {'title': 'Moderate or High Disease Activity', 'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}, {'title': 'Low Disease Activity', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}, {'title': 'Moderate or High Disease Activity', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '352', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}, {'title': 'Low Disease Activity', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}, {'title': 'Moderate or High Disease Activity', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '319', 'groupId': 'OG002'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}, {'title': 'Low Disease Activity', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}, {'title': 'Moderate or High Disease Activity', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': 'DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln\\[ESR\\]) +(0.014 × VASPA)\n\n* Remission = DAS28(ESR) \\< 2.6\n* Low disease activity = 2.6 ≤ DAS28 ≤ 3.2\n* Moderate disease activity = 3.2 \\< DAS28 ≤ 5.1\n* High disease activity = DAS28 \\> 5.1\n\nDisease activity based on DAS28(ESR) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITO Population'}, {'type': 'PRIMARY', 'title': 'Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '406', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg q2w + MTX'}, {'id': 'OG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg q2w'}, {'id': 'OG002', 'title': 'Total (C203 All Subjects)', 'description': 'C203 All Subjects'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '405', 'groupId': 'OG002'}]}], 'categories': [{'title': 'DAS(CRP) < 2.6', 'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}, {'title': 'Low Disease Activity', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}, {'title': 'Moderate or High Disease Activity', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '391', 'groupId': 'OG002'}]}], 'categories': [{'title': 'DAS(CRP) < 2.6', 'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}]}, {'title': 'Low Disease Activity', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}, {'title': 'Moderate or High Disease Activity', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '362', 'groupId': 'OG002'}]}], 'categories': [{'title': 'DAS(CRP) < 2.6', 'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}]}, {'title': 'Low Disease Activity', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}, {'title': 'Moderate or High Disease Activity', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '327', 'groupId': 'OG002'}]}], 'categories': [{'title': 'DAS(CRP) < 2.6', 'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}]}, {'title': 'Low Disease Activity', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}, {'title': 'Moderate or High Disease Activity', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': 'DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln\\[CRP+1\\]) + (0.014 × VASPA) + 0.96\n\n* DAS28(CRP) \\< 2.6\n* Low disease activity = 2.6 ≤ DAS28 ≤ 3.2\n* Moderate disease activity = 3.2 \\< DAS28 ≤ 5.1\n* High disease activity = DAS28 \\> 5.1\n\nDisease activity based on DAS28(CRP) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITO Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg s.c. q2w + methotrexate (MTX)'}, {'id': 'FG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg s.c. q2w'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Sponsor's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy Wish', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 406 subjects was enrolled at 56 sites located in Europe (48 sites, 333 subjects) and Latin America (8 sites, 73 subjects). Consent was obtained from the first subject on 13 July 2015; the last subject completed the final visit on 23 August 2018.', 'preAssignmentDetails': 'A total of 472 subjects completed the entire treatment and assessment period of the preceding Phase IIb studies (placebo and ALX-0061 treatment arms only). Of these, 406 subjects were enrolled in this study. All screened subjects were included in the Intent-to-observe (ITO) Population. Overall, 405 subjects were included in the Safety Population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ALX-0061 150 mg q2w + MTX (C201 All Subjects)', 'description': 'ALX-0061 150 mg s.c. q2w + MTX'}, {'id': 'BG001', 'title': 'ALX-0061 150 mg q2w (C202 All Subjects)', 'description': 'ALX-0061 150 mg s.c. q2w'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '12.26', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '12.01', 'groupId': 'BG001'}, {'value': '51.5', 'spread': '12.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '332', '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': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '244', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '393', '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': 'Region of Enrollment', 'classes': [{'title': 'Romania', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Macedonia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Moldova', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Georgia', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-10', 'size': 1034509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-23T07:31', 'hasProtocol': True}, {'date': '2018-10-04', 'size': 1860332, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-23T07:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-19', 'studyFirstSubmitDate': '2015-08-06', 'resultsFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2015-08-07', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-23', 'studyFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': "ACR 20 response is defined as:\n\n* 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND\n* 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND\n* 20% improvement in 3 of the following 5 areas relative to Week 0:\n\n * Subject's Assessment of Pain (100 mm - visual analogue scale \\[VAS\\])\n * Subject's Global Assessment of Disease Activity (VASPA)\n * Physician's Global Assessment of Disease Activity (VASPHA)\n * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)\n * C-reactive protein (CRP) level\n\nACR20 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."}, {'measure': 'Number and Percentage of Subjects With ACR50 Response.', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': "ACR50 response is defined as:\n\n* 50% improvement in TJC (68 joints) relative to Week 0 AND\n* 50% improvement in SJC (66 joints) relative to Week 0 AND\n* 50% improvement in 3 of the following 5 areas relative to Week 0:\n\n * Subject's Assessment of Pain (100 mm - VAS)\n * Subject's Global Assessment of Disease Activity (VASPA)\n * Physician's Global Assessment of Disease Activity (VASPHA)\n * Subject's assessment of physical function as measured by HAQ-DI\n * CRP level\n\nACR50 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."}, {'measure': 'Number and Percentage of Subjects With ACR70 Response.', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': "ACR70 response is defined as:\n\n* 70% improvement in TJC (68 joints) relative to Week 0 AND\n* 70% improvement in SJC (66 joints) relative to Week 0 AND\n* 70% improvement in 3 of the following 5 areas relative to Week 0:\n\n * Subject's Assessment of Pain (100 mm - VAS)\n * Subject's Global Assessment of Disease Activity (VASPA)\n * Physician's Global Assessment of Disease Activity (VASPHA)\n * Subject's assessment of physical function as measured by HAQ-DI\n * CRP level\n\nACR70 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."}, {'measure': 'ACR-N Index of Improvement', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': "The ACR-N Index of Improvement is defined as the minimum of the following 3 criteria:\n\n* The percent improvement from Week 0 in TJCs\n* The percent improvement from Week 0 in SJCs\n* The median percent improvement from Week 0 for the following 5 assessments:\n\n * Subject's assessment of pain (VAS)\n * Subject's global assessment of disease activity (VASPHA)\n * Physician's global assessment of disease activity (VASPHA)\n * Subject's assessment of physical function as measured by the HAQ-DI\n * CRP level\n\nACR-N Index of Improvement was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."}, {'measure': 'Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': 'DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln\\[ESR\\]) +(0.014 × VASPA)\n\n* Remission = DAS28(ESR) \\< 2.6\n* Low disease activity = 2.6 ≤ DAS28 ≤ 3.2\n* Moderate disease activity = 3.2 \\< DAS28 ≤ 5.1\n* High disease activity = DAS28 \\> 5.1\n\nDisease activity based on DAS28(ESR) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.'}, {'measure': 'Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)', 'timeFrame': 'At Weeks 0, 12, 48, and 104', 'description': 'DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln\\[CRP+1\\]) + (0.014 × VASPA) + 0.96\n\n* DAS28(CRP) \\< 2.6\n* Low disease activity = 2.6 ≤ DAS28 ≤ 3.2\n* Moderate disease activity = 3.2 \\< DAS28 ≤ 5.1\n* High disease activity = DAS28 \\> 5.1\n\nDisease activity based on DAS28(CRP) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously (s.c.) in subjects with active rheumatoid arthritis (RA) who had completed the treatment and assessment period of one of the preceding Phase IIb studies with ALX-0061 (ALX0061-C201 and ALX0061-C202; placebo and ALX-0061 treatment arms only), and who achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) (66/68 counts) compared to Baseline at the final visit of the preceding study (i.e., Week 24 for Study ALX0061-C201 and Week 12 for Study ALX0061-C202).', 'detailedDescription': 'Eligible subjects received one of the following treatments during the preceding Phase IIb studies ALX0061-C201 and ALX0061-C202:\n\n* Study ALX0061-C201:\n\n * Placebo (+ methotrexate \\[MTX\\]), or\n * ALX-0061 75 mg every 4 weeks (q4w) (+ MTX), or\n * ALX-0061 150 mg q4w (+ MTX), or\n * ALX-0061 150 mg every 2 weeks (q2w) (+ MTX), or\n * ALX-0061 225 mg q2w (+ MTX), for 24 weeks\n* Study ALX0061-C202:\n\n * ALX-0061 150 mg q4w, or\n * ALX-0061 150 mg q2w, or\n * ALX-0061 225 mg q2w, for 12 weeks\n\nAt the Week 24 (ALX0061-C201) or Week 12 (ALX0061-C202) visit of the previous study, informed consent was obtained from all subjects who were deemed potentially eligible for the OLE study, according to the inclusion and exclusion criteria. This was marked as the Week 0 visit of the C203 study. Of note, the Baseline time point in the analyses of this study was defined the Baseline value of the parent study.\n\nIn this OLE study, eligible subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and every 2 weeks thereafter, up to and including Week 102. Eligible subjects from the preceding study ALX0061-C201 also continued their MTX treatment.\n\nMaintenance of the response (i.e., at least 20% improvement in both SJC and TJC compared to Baseline of the preceding study) was reassessed at the study visits at Weeks 12, 24, 36, 48, 60, 72, 84, and 96. Subjects who failed to maintain response and met the Efficacy Discontinuation Criteria were discontinued from this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have been eligible for one of the preceding Phase IIb studies with ALX-0061 (study ALX0061-C201 or ALX0061-C202), have been randomized to placebo or one of the ALX-0061 arms (subjects randomized to tocilizumab \\[TCZ\\] in study ALX0061-C202 were not eligible), and completed the entire treatment and assessment period of the preceding studies (i.e., 24 weeks for study ALX0061-C201 and 12 weeks for study ALX0061-C202).\n* Must have reached at least 20% improvement in SJC and/or TJC (66/68 counts) compared to Week 0 at Week 24 for subjects participating in the preceding Phase IIb ALX0061 C201 study, or at Week 12 for subjects participating in the preceding Phase IIb ALX0061-C202 study\n* Female subjects of childbearing potential (excluding postmenopausal women, sterilized, ovariectomized, and hysterectomized women) must agree to use 2 generally accepted adequate contraceptive methods of which 1 is a barrier method (e.g., hormonal contraception stabilized for at least 1 month \\[oral, patch, depot, injectable, vaginal ring\\] in combination with condom by partner) or should agree upon continuous abstinence from heterosexual contact from screening/baseline until at least 6 months after last dosing. Male subjects must use condoms for the duration of the study and for at least 6 months after last administration of study drug.\n* Ability to comprehend and willingness to sign the informed consent form (ICF).\n* An understanding of and ability and willingness to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Received TCZ during the previous Study ALX0061-C202.\n* Received any prohibited treatment during the previous Phase IIb studies (ALX0061-C201 or ALX0061-C202.\n* Diagnosis of or suspicion of a serious infection (requiring parental antibiotics and/or hospitalization) or tuberculosis during the preceding study.\n* Diagnosis of malignancy or demyelinating disease during the preceding study.\n* Any active or recurrent viral infection that made the subject unsuitable for the study based on the Investigator's clinical assessment, including recurrent/disseminated herpes zoster.\n* Diagnosis of congestive heart failure class III or IV (as defined by the New York Heart Association), unstable angina pectoris, myocardial infarction, and/or cerebrovascular accident during the preceding study.\n* Abnormality in laboratory test results observed at the Week 22 visit for subjects participating in the preceding Phase IIb ALX0061-C201 study, or observed at the Week 10 visit for subjects participating in the preceding Phase IIb ALX0061-C202 study:\n\n 1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ 2 times the upper limit of normal (ULN).\n 2. Hemoglobin levels ≤ 85 g/L (8.5 g/dL).\n 3. Platelet count ≤ 75 x 109/L (75,000 cells/mm³).\n 4. Absolute neutrophil count \\< 1.5 x 109/L.\n 5. Serum creatinine levels ≥ 1.5 mg/dL (133 μmol/L).\n 6. Any other clinically significant abnormal laboratory result as evaluated by the Investigator.\n 7. If no laboratory test results of the Week 22 Visit (for subjects participating in the preceding ALX0061-C201 study) or the Week 10 Visit (for subjects participating in the preceding ALX0061-C202 study) were available, then laboratory values of tests performed between Week 22 and 24 (for study ALX0061-C201) or Week 10 and 12 (for study ALX0061-C202) were taken into account for the exclusion criteria a to e listed above."}, 'identificationModule': {'nctId': 'NCT02518620', 'briefTitle': 'An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ablynx, a Sanofi company'}, 'officialTitle': 'A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061', 'orgStudyIdInfo': {'id': 'ALX0061-C203'}, 'secondaryIdInfos': [{'id': '2014-003034-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALX-0061 150 mg q2w (+ MTX)', 'interventionNames': ['Biological: ALX-0061']}], 'interventions': [{'name': 'ALX-0061', 'type': 'BIOLOGICAL', 'otherNames': ['Vobarilizumab'], 'description': 'Subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and q2w thereafter, up to and including Week 102. Subjects from the preceding study ALX0061-C201 also continued their MTX treatment.', 'armGroupLabels': ['ALX-0061 150 mg q2w (+ MTX)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Investigator Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Investigator Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Investigator Site', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Investigator site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Investigator Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Investigator Site', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 4', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 5', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigator Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Baja', 'country': 'Hungary', 'facility': 'Investigator Site', 'geoPoint': {'lat': 46.18299, 'lon': 18.95307}}, {'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Investigator site', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'city': 'Békéscsaba', 'country': 'Hungary', 'facility': 'Investigator site', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'city': 'Gyula', 'country': 'Hungary', 'facility': 'Investigator Site', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'city': 'Székesfehérvar', 'country': 'Hungary', 'facility': 'Investigator Site'}, {'city': 'Szikszó', 'country': 'Hungary', 'facility': 'Investigator Site', 'geoPoint': {'lat': 48.2, 'lon': 20.93333}}, {'city': 'Szombathely', 'country': 'Hungary', 'facility': 'Investigator Site', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'city': 'Veszprém', 'country': 'Hungary', 'facility': 'Investigator Site', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'city': 'Culiacán', 'country': 'Mexico', 'facility': 'Investigator site', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'city': 'León', 'country': 'Mexico', 'facility': 'Investigator site', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Investigator site 1', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Investigator site 2', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mérida', 'country': 'Mexico', 'facility': 'Investigator site', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'city': 'Monclova', 'country': 'Mexico', 'facility': 'Investigator site', 'geoPoint': {'lat': 26.90687, 'lon': -101.42056}}, {'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Investigator site 1', 'geoPoint': {'lat': 25.68435, 'lon': 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