Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-22 @ 7:38 PM
Study NCT ID:
NCT00306592
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2006-01-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Natalizumab Re-Initiation of Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069442', 'term': 'Natalizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogenidec.com', 'title': 'Biogen Idec Study Medical Director', 'organization': 'Biogen Idec'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs were collected from the time of enrollment, and AEs from the time of first dose of natalizumab, until Week 48.', 'description': 'Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.', 'eventGroups': [{'id': 'EG000', 'title': '300 mg Natalizumab IV Monthly', 'description': 'All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.', 'otherNumAtRisk': 1094, 'otherNumAffected': 492, 'seriousNumAtRisk': 1094, 'seriousNumAffected': 61}], 'otherEvents': [{'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 156}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 141}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 119}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 91}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 85}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Viral meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Staphyloccal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Small intestine obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intra-uterine death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ovarian torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1094, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg Natalizumab IV Monthly', 'description': 'All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '826', 'groupId': 'OG000'}]}]}, {'title': 'Moderate or severe AE', 'categories': [{'measurements': [{'value': '487', 'groupId': 'OG000'}]}]}, {'title': 'Severe AE', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'AE related to study drug', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'SAE related to study drug', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation of study drug due to AE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal from study due to AE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 48', 'description': 'AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants receiving at least 1 dose of study drug'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hypersensitivity-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg Natalizumab IV Monthly', 'description': 'All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 48', 'description': "For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants receiving at least 1 dose of study drug'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Antibodies to Natalizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1043', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '300 mg Natalizumab IV Monthly', 'description': 'All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.'}], 'classes': [{'title': 'Antibody negative', 'categories': [{'measurements': [{'value': '1004', 'groupId': 'OG000'}]}]}, {'title': 'Antibody positive with unknown persistence', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Antibody transient positive', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Antibody persistent positive', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)', 'description': "'Positive with unknown persistence' is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of natalizumab, had a negative baseline antibody result, and had at least 1 antibody result after the first dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Natalizumab Study 101-MS-322 (NCT00306592)', 'description': 'Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.'}, {'id': 'FG001', 'title': 'Natalizumab Study 101-MS-321 (NCT00297232)', 'description': 'Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '690'}]}, {'type': 'Completed at 24 Weeks', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Completed Between 24 and 48 Weeks', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Completed at 48 Weeks', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '632'}]}, {'type': 'Entered 101-MS-321 Extension Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'comment': 'pertains to participants transitioning from 101-MS-322 (NCT00306592) study only', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '373'}, {'groupId': 'FG001', 'numSubjects': '632'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Persistent Antibodies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Voluntary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': '48-week Treatment Period Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': 'Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined Week 48 data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1094', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '300 mg Natalizumab IV Monthly', 'description': 'All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '8.12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≥ 18 to < 20 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '≥ 20 to < 30 years', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}]}]}, {'title': '≥ 30 to < 40 years', 'categories': [{'measurements': [{'value': '347', 'groupId': 'BG000'}]}]}, {'title': '≥ 40 to < 50 years', 'categories': [{'measurements': [{'value': '454', 'groupId': 'BG000'}]}]}, {'title': '≥ 50 to < 59 years', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}]}]}, {'title': '>/= 60 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '755', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '339', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants from 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) are combined.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2006-01-31', 'resultsFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2006-03-22', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-12-20', 'studyFirstPostDateStruct': {'date': '2006-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)', 'timeFrame': 'Baseline through Week 48', 'description': 'AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.'}, {'measure': 'Number of Participants With Hypersensitivity-related Adverse Events', 'timeFrame': 'Baseline through Week 48', 'description': "For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria."}, {'measure': 'Number of Participants With Antibodies to Natalizumab', 'timeFrame': 'Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)', 'description': "'Positive with unknown persistence' is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'MS'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'references': [{'pmid': '24898925', 'type': 'BACKGROUND', 'citation': "O'Connor P, Goodman A, Kappos L, Lublin F, Polman C, Rudick RA, Hauswirth K, Cristiano LM, Forrestal F, Duda P. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology. 2014 Jul 1;83(1):78-86. doi: 10.1212/WNL.0000000000000541. Epub 2014 Jun 4."}], 'seeAlsoLinks': [{'url': 'http://www.nationalmssociety.org', 'label': 'The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.)'}, {'url': 'http://www.msactivesource.com', 'label': '(MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen Idec.)'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.', 'detailedDescription': 'Study 101-MS-322 (NCT00306592) is conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab of former clinical trial participants in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760). This study includes participants in North America. In parallel with the conduct of this study, a similar study, 101-MS-321 (NCT00297232) is initiated for participants in Europe and the rest of the world. The primary purpose and primary outcome for both studies are identical, therefore, the combined Week 48 data from both studies are presented. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) can enter study 101-MS-321 (NCT 00297232), which is considered the Long-Term Treatment Period of 101-MS-322 (NCT00306592).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging \\[MRI\\] scan)\n* Considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 \\[NCT000276172\\] may be used)\n* Other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Considered by the investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment\n* History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00306592', 'briefTitle': 'Natalizumab Re-Initiation of Dosing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation', 'orgStudyIdInfo': {'id': '101-MS-322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Natalizumab', 'description': 'All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.', 'interventionNames': ['Biological: BG00002 (natalizumab)']}], 'interventions': [{'name': 'BG00002 (natalizumab)', 'type': 'BIOLOGICAL', 'otherNames': ['Tysabri'], 'armGroupLabels': ['Natalizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80919', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33060', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.23786, 'lon': 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{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.8976, 'lon': 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-74.00597}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '13202', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75214', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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-81.23304}}, {'zip': 'M4N 3M5', 'city': 'New York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Center'}, {'zip': 'K2G6E2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J8Y1W7', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'J4V2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H3A2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Elan Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}