Ignite Creation Date:
2025-12-24 @ 12:33 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT03277261
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2017-09-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619007', 'term': 'ublituximab'}, {'id': 'C527525', 'term': 'teriflunomide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalsupport@tgtxinc.com', 'phone': '1-877-575-8489', 'title': 'TG Therapeutics Clinical Support Team', 'organization': 'TG Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug through the end of the study (up to approximately 116 weeks)', 'description': 'All-Cause Mortality: All the enrolled participants; Adverse Events: Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).', 'eventGroups': [{'id': 'EG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 274, 'otherNumAffected': 197, 'seriousNumAtRisk': 273, 'deathsNumAffected': 2, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).', 'otherNumAtRisk': 275, 'deathsNumAtRisk': 275, 'otherNumAffected': 181, 'seriousNumAtRisk': 275, 'deathsNumAffected': 0, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oesophageal achalasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Central nervous system enteroviral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bullous erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Meningoencephalitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Salpingitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Neurological symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Acoustic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Medical device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 275, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Relapse Rate (ARR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'OG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.076', 'groupId': 'OG000', 'lowerLimit': '0.042', 'upperLimit': '0.138'}, {'value': '0.188', 'groupId': 'OG001', 'lowerLimit': '0.124', 'upperLimit': '0.283'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio (Ublituximab/Teriflunomide)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.406', 'ciLowerLimit': '0.268', 'ciUpperLimit': '0.615', 'pValueComment': 'GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.', 'statisticalMethod': 'Negative Binomial Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 96 weeks', 'description': 'ARR is defined as the number of Independent Relapse Adjudication Panel (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group.', 'unitOfMeasure': 'relapses per participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention-to-Treat (mITT) population consisted of all participants in the ITT population who received at least one dose of study medication and have at least one baseline and post baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'OG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.016', 'groupId': 'OG000', 'lowerLimit': '0.008', 'upperLimit': '0.032'}, {'value': '0.491', 'groupId': 'OG001', 'lowerLimit': '0.355', 'upperLimit': '0.679'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio (Ublituximab/Teriflunomide)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.033', 'ciLowerLimit': '0.019', 'ciUpperLimit': '0.058', 'pValueComment': 'GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.', 'statisticalMethod': 'Negative Binomial Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 12, 24, 48, and 96', 'description': 'The total number of Gd-enhancing T1-lesions were calculated as the sum of the individual number of lesions at Weeks 12, 24, 48, and 96, divided by the total number of MRI scans of the brain.', 'unitOfMeasure': 'lesions per scan per participant', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT- magnetic resonance imaging (MRI) population included participants in mITT population who have baseline and post-baseline MRI efficacy assessments. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'OG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.213', 'groupId': 'OG000', 'lowerLimit': '0.144', 'upperLimit': '0.316'}, {'value': '2.789', 'groupId': 'OG001', 'lowerLimit': '2.136', 'upperLimit': '3.643'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio (Ublituximab/Teriflunomide)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.076', 'ciLowerLimit': '0.056', 'ciUpperLimit': '0.104', 'pValueComment': 'GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.', 'statisticalMethod': 'Negative Binomial Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 24, 48, and 96', 'description': 'The total number of NELs were calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96, divided by the total number of MRI scans of the brain.', 'unitOfMeasure': 'lesions per scan per participant', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT- MRI population included participants in mITT population who have baseline and post-baseline MRI efficacy assessments. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '543', 'groupId': 'OG000'}, {'value': '546', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'OG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and Inter Quartile Range was not reached due to the low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and Inter Quartile Range was not reached due to the low number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 96', 'description': '12-week CDP is defined as an increase in EDSS at least 1 point higher than the baseline EDSS if the baseline EDSS is ≤5.5 or at least 0.5 higher than the baseline EDSS if the baseline EDSS is \\>5.5. The EDSS is based on a standard neurological examination, (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cerebral) and ambulation function system assessments. The EDSS disability scale ranges in 0.5-point steps from 0 (normal) to 10 (death) where higher scores indicate disability. The time to onset of 12-week CDP is the time to progression to the EDSS change defined above.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisted of all participants in the ITT population who received at least one dose of study medication and have at least one baseline and post baseline efficacy assessment. As per protocol, data was summarized for the mITT Population using pooled data from participants in this study and TG1101-RMS302 \\[NCT03277248\\].'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With No Evidence of Disease Activity (NEDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'OG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (Ublituximab/Teriflunomide)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.442', 'ciLowerLimit': '3.536', 'ciUpperLimit': '8.375', 'pValueComment': 'Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 up to Week 96', 'description': 'A participant with NEDA is defined as a participant without relapses confirmed by the IRAP, without MRI activities (no T1 Gd+ lesions and no new/enlarging T2 lesions), and no 12-week CDP. Any evidence of disease activity from Week 24 to Week 96 was counted as not reaching NEDA. Any evidence of disease activity before Week 24 was not counted.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisted of all participants in the ITT population who received at least one dose of study medication and have at least one baseline and post baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'OG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered Teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '31.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.4669', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (Ublituximab/Teriflunomide)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.872', 'ciLowerLimit': '0.603', 'ciUpperLimit': '1.261', 'pValueComment': 'Logistic regression model with treatment, region, baseline EDSS strata, and log-transformed baseline MRI counts (T1 unenhancing, T2, Gd enhancing) as covariates.', 'statisticalMethod': 'Logistic Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 96', 'description': 'The SDMT involves a simple substitution task using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses are done verbally. The administration time is approximately 5 minutes. The total SDMT score for each visit ranging from 0-110 is defined as the total number of correct answers reported in the case report form (CRF), where high scores indicate better outcome. Impaired SDMT is defined as a decrease from baseline of at least 4 points at any post-baseline assessment up to the Week 96 visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population consisted of all participants in the ITT population who received at least one dose of study medication and have at least one baseline and post baseline efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Brain Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'OG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.197', 'groupId': 'OG000', 'lowerLimit': '-0.228', 'upperLimit': '-0.166'}, {'value': '-0.125', 'groupId': 'OG001', 'lowerLimit': '-0.155', 'upperLimit': '-0.095'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.072', 'ciLowerLimit': '-0.107', 'ciUpperLimit': '-0.036', 'pValueComment': 'The model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.', 'statisticalMethod': 'Mixed Model Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Week 96', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT- MRI population included participants in mITT population who have baseline and post-baseline MRI efficacy assessments. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'OG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '86.1', 'groupId': 'OG000'}, {'value': '89.1', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug through the end of the study (up to approximately 116 weeks)', 'description': 'An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious AE is defined as any untoward medical occurrence that: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and/or causes a congenital anomaly/birth defect. A TEAE is an AE that starts or worsens after receiving study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug (ublituximab or teriflunomide, with corresponding placebos).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 milligrams (mg), intravenous (IV) infusion over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo once daily (QD) from Day 1 up to the last day of Week 95.'}, {'id': 'FG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '275'}]}, {'type': 'COMPLETED', 'comment': 'The completed number of participants denote the population who completed the 96 weeks Treatment Period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '240'}, {'groupId': 'FG001', 'numSubjects': '252'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Investigator / Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other-Alternative Treatment/Unspecified Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 549 participants were enrolled across investigative sites in Belarus, Spain, the United Kingdom, Georgia, Poland, Russia, Serbia, Ukraine, and the United States from 19 September 2017 to 6 November 2020.', 'preAssignmentDetails': 'A total of 646 participants were screened and of those, 549 were enrolled and randomized to receive either ublituximab/oral placebo or teriflunomide/IV placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 mg, IV infusion over 4 h on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo QD from Day 1 up to the last day of Week 95.'}, {'id': 'BG001', 'title': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '8.48', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '9.62', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '9.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '347', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '534', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention-to-Treat (ITT) population consisted of all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-04', 'size': 9049380, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-03T07:05', 'hasProtocol': True}, {'date': '2020-09-04', 'size': 11725182, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-03T07:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded, active-controlled study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, multi-center, double-blinded, active-controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 549}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2021-05-11', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2017-09-07', 'dispFirstSubmitQcDate': '2021-05-11', 'resultsFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2017-09-07', 'dispFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-05', 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Relapse Rate (ARR)', 'timeFrame': 'Up to 96 weeks', 'description': 'ARR is defined as the number of Independent Relapse Adjudication Panel (IRAP)-confirmed relapses per participant year. The estimate of ARR for a treatment group is the total number of relapses for participants in the respective treatment group divided by the sum of treatment duration for participants in that specific treatment group.'}], 'secondaryOutcomes': [{'measure': 'Total Number of Gadolinium (Gd)-Enhancing T1-Lesions Per Magnetic Resonance Imaging (MRI) Scan Per Participant', 'timeFrame': 'Weeks 12, 24, 48, and 96', 'description': 'The total number of Gd-enhancing T1-lesions were calculated as the sum of the individual number of lesions at Weeks 12, 24, 48, and 96, divided by the total number of MRI scans of the brain.'}, {'measure': 'Total Number of New and Enlarging T2 Hyperintense Lesions (NELs) Per MRI Scan Per Participant', 'timeFrame': 'Weeks 24, 48, and 96', 'description': 'The total number of NELs were calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96, divided by the total number of MRI scans of the brain.'}, {'measure': 'Time to Confirmed Disability Progression (CDP) for at Least 12 Weeks', 'timeFrame': 'Up to Week 96', 'description': '12-week CDP is defined as an increase in EDSS at least 1 point higher than the baseline EDSS if the baseline EDSS is ≤5.5 or at least 0.5 higher than the baseline EDSS if the baseline EDSS is \\>5.5. The EDSS is based on a standard neurological examination, (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cerebral) and ambulation function system assessments. The EDSS disability scale ranges in 0.5-point steps from 0 (normal) to 10 (death) where higher scores indicate disability. The time to onset of 12-week CDP is the time to progression to the EDSS change defined above.'}, {'measure': 'Percentage of Participants With No Evidence of Disease Activity (NEDA)', 'timeFrame': 'Week 24 up to Week 96', 'description': 'A participant with NEDA is defined as a participant without relapses confirmed by the IRAP, without MRI activities (no T1 Gd+ lesions and no new/enlarging T2 lesions), and no 12-week CDP. Any evidence of disease activity from Week 24 to Week 96 was counted as not reaching NEDA. Any evidence of disease activity before Week 24 was not counted.'}, {'measure': 'Percentage of Participants With Impaired Symbol Digit Modalities Test (SDMT)', 'timeFrame': 'Baseline up to Week 96', 'description': 'The SDMT involves a simple substitution task using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses are done verbally. The administration time is approximately 5 minutes. The total SDMT score for each visit ranging from 0-110 is defined as the total number of correct answers reported in the case report form (CRF), where high scores indicate better outcome. Impaired SDMT is defined as a decrease from baseline of at least 4 points at any post-baseline assessment up to the Week 96 visit.'}, {'measure': 'Percent Change From Baseline in Brain Volume', 'timeFrame': 'Baseline up to Week 96'}, {'measure': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From the first dose of study drug through the end of the study (up to approximately 116 weeks)', 'description': 'An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious AE is defined as any untoward medical occurrence that: results in death, is immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, and/or causes a congenital anomaly/birth defect. A TEAE is an AE that starts or worsens after receiving study drug.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsing Multiple Sclerosis (RMS)']}, 'referencesModule': {'references': [{'pmid': '39512280', 'type': 'DERIVED', 'citation': 'Alvarez E, Steinman L, Fox EJ, Hartung HP, Qian P, Wray S, Robertson D, Selmaj K, Wynn D, Mok K, Xu Y, Bodhinathan K, Miskin HP, Cree BAC. Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis. Front Neurol. 2024 Oct 24;15:1473284. doi: 10.3389/fneur.2024.1473284. eCollection 2024.'}, {'pmid': '36001711', 'type': 'DERIVED', 'citation': 'Steinman L, Fox E, Hartung HP, Alvarez E, Qian P, Wray S, Robertson D, Huang D, Selmaj K, Wynn D, Cutter G, Mok K, Hsu Y, Xu Y, Weiss MS, Bosco JA, Power SA, Lee L, Miskin HP, Cree BAC; ULTIMATE I and ULTIMATE II Investigators. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2022 Aug 25;387(8):704-714. doi: 10.1056/NEJMoa2201904.'}]}, 'descriptionModule': {'briefSummary': 'This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96 weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral placebo compared to 14 mg oral teriflunomide/IV placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-55 age\n* Diagnosis of RMS (McDonald criteria 2010)\n* Active disease\n* Expanded disability status scale (EDSS) 0-5.5 (inclusive) at screening\n\nExclusion Criteria:\n\n* Treatment with prior Anti-cluster of differentiate 20 (CD20) or other B cell directed treatment\n* Treatment with the following therapies at any time prior to randomization: alemtuzumab, natalizumab, teriflunomide, leflunomide and stem cell transplantation\n* Diagnosed with Primary Progressive MS (PPMS)\n* Pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT03277261', 'acronym': 'ULTIMATE 1', 'briefTitle': 'Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )', 'organization': {'class': 'INDUSTRY', 'fullName': 'TG Therapeutics, Inc.'}, 'officialTitle': 'Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)', 'orgStudyIdInfo': {'id': 'TG1101-RMS301'}, 'secondaryIdInfos': [{'id': '2017-000638-75', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ublituximab + Oral Placebo', 'description': 'Participants were administered ublituximab 150 milligrams (mg), intravenous (IV) infusion over 4 hours (h) on Day 1 followed by 450 mg over 1 h on Days 15, 168, 336 and 504 (Week 72) along with the oral placebo once daily (QD) from Day 1 up to the last day of Week 95.', 'interventionNames': ['Biological: Ublituximab', 'Drug: Oral Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Teriflunomide + IV Placebo', 'description': 'Participants were administered teriflunomide 14 mg tablet, orally, QD from Day 1 up to the last day of Week 95 along with the placebo IV infusion on Days 1, 15, 168, 336 and 504 (Week 72).', 'interventionNames': ['Drug: Teriflunomide', 'Drug: IV Placebo']}], 'interventions': [{'name': 'Ublituximab', 'type': 'BIOLOGICAL', 'otherNames': ['TG-1101'], 'description': 'Administered as an IV infusion.', 'armGroupLabels': ['Ublituximab + Oral Placebo']}, {'name': 'Teriflunomide', 'type': 'DRUG', 'description': 'Film-coated tablets administered orally.', 'armGroupLabels': ['Teriflunomide + IV Placebo']}, {'name': 'Oral Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Ublituximab + Oral Placebo']}, {'name': 'IV Placebo', 'type': 'DRUG', 'description': 'Administered as an IV infusion.', 'armGroupLabels': ['Teriflunomide + IV Placebo']}]}, 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'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Trial Site', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Trial Site', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Trial Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Trial Site', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '43081', 'city': 'Westerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Trial Site', 'geoPoint': {'lat': 40.12617, 'lon': -82.92907}}, {'zip': '37064', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Trial Site', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Trial Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Trial Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'TG Therapeutics RMS Investigational Site', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be shared after study completion via publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TG Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}