Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT00280956
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2006-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2006-01-21', 'studyFirstSubmitQcDate': '2006-01-21', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety of natalizumab by the number and proportion of subjects with adverse events, and by assessing clinical laboratory parameters and vital signs.'}]}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Male and Female Subjects 18 years and older with Crohn's Disease who have participated in studies CD251, CD301, CD303, CD306, or CD307 per protocol"}, 'identificationModule': {'nctId': 'NCT00280956', 'briefTitle': "Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': "A Phase III, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren™ (Natalizumab) in Crohn's Disease Subjects Who Have Previously Participated in Antegren Crohn's Disease Studies", 'orgStudyIdInfo': {'id': 'CD351'}}, 'armsInterventionsModule': {'interventions': [{'name': 'natalizumab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Performed only at CD251, CD301, CD303, CD306, and CD307 sites globally. No general public enrollment. The study is managed from the office of Elan Pharmaceuticals, Inc. in', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Elan Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}