Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-02 @ 11:49 AM
Study NCT ID:
NCT01884935
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2013-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2013-06-20', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predose (trough) concentrations from multiple dosing (Cpredose)', 'timeFrame': 'Up to week 16'}, {'measure': 'maximum plasma concentration (Cmax)', 'timeFrame': 'Up to Week 16'}, {'measure': 'time to maximum plasma concentration (Tmax)', 'timeFrame': 'Up to Week 16'}, {'measure': 'area under the plasma concentration curve from time of first dose to infinity (AUCinf)', 'timeFrame': 'Up to Week 16'}, {'measure': 'apparent clearance (Cl/F)', 'timeFrame': 'Up to Week 16'}, {'measure': 'volume of distribution', 'timeFrame': 'Up to Week 16'}, {'measure': 'elimination half-life (t1/2)', 'timeFrame': 'Up to Week 16'}], 'secondaryOutcomes': [{'measure': 'the average and minimum saturation values of α4 integrin over the dosing interval', 'timeFrame': 'Up to Week 16'}, {'measure': 'incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs', 'timeFrame': 'Up to Week 16'}, {'measure': 'the presence of anti-natalizumab antibodies', 'timeFrame': 'Up to Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediatric'], 'conditions': ['Relapsing-Remitting Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-005082-13/results', 'label': 'EudraCT Tabulated Result'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n\\- Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)\n\nKey Exclusion Criteria:\n\n* History of, or abnormal laboratory values indicative of, significant medical, neurologic (other than MS), or psychiatric disorders that might preclude participation in the study in the opinion of the Investigator.\n* Prior natalizumab therapy.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01884935', 'briefTitle': 'PK and PD Study of Natalizumab in Pediatric Subjects With RRMS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)', 'orgStudyIdInfo': {'id': '101MS328'}, 'secondaryIdInfos': [{'id': '2012-005082-13'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Natalizumab', 'description': '300 mg intravenously (IV) every 4 weeks', 'interventionNames': ['Biological: Natalizumab']}], 'interventions': [{'name': 'Natalizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Tysabri', 'BG00002'], 'description': 'As specified in the treatment arm', 'armGroupLabels': ['Natalizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cefalù', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 38.03856, 'lon': 14.02285}}, {'city': 'Gallarate', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.66019, 'lon': 8.79164}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}