Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT00279734
Status:
COMPLETED
Last Update Posted:
2011-04-13
First Post:
2006-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D000069594', 'term': 'Abatacept'}, {'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-11', 'studyFirstSubmitDate': '2006-01-19', 'studyFirstSubmitQcDate': '2006-01-19', 'lastUpdatePostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.'}], 'secondaryOutcomes': [{'measure': 'Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.'}]}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '17425783', 'type': 'DERIVED', 'citation': 'Tay L, Leon F, Vratsanos G, Raymond R, Corbo M. Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects. Arthritis Res Ther. 2007;9(2):R38. doi: 10.1186/ar2174.'}]}, 'descriptionModule': {'briefSummary': 'Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Subjects\n* Body Weight between 60 and 100 kg.\n* Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation.\n\nExclusion Criteria:\n\n* Females who are prgnant or breastfeeding\n* History of autoimmune disorder, immunodeficiency, or infection within past 3 months.\n* Active TB requiring treatment within the previous 3 years.\n* Positive breast cancer screen, PPD test.\n* Vaccination with tetanus or pneumococcal vaccine within 5 years.\n* Vaccination with any live vaccine within 4 weeks.\n* History of drug or alcohol abuse.\n* Any significant allergy.'}, 'identificationModule': {'nctId': 'NCT00279734', 'briefTitle': 'Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects', 'orgStudyIdInfo': {'id': 'IM101-049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Drug: Tetanus + pnemococcal vaccines alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'interventionNames': ['Drug: Abatacept + vaccines']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'interventionNames': ['Drug: Abatacept + vaccines']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'interventionNames': ['Drug: Abatacept + Vaccines']}], 'interventions': [{'name': 'Tetanus + pnemococcal vaccines alone', 'type': 'DRUG', 'description': '0 mg + vaccines, Single dose, 28 days.', 'armGroupLabels': ['Group 1']}, {'name': 'Abatacept + vaccines', 'type': 'DRUG', 'otherNames': ['Orencia'], 'description': 'Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.', 'armGroupLabels': ['Group 2']}, {'name': 'Abatacept + vaccines', 'type': 'DRUG', 'otherNames': ['Orencia'], 'description': 'Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.', 'armGroupLabels': ['Group 3']}, {'name': 'Abatacept + Vaccines', 'type': 'DRUG', 'otherNames': ['Orencia'], 'description': 'parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Qutintiles Phase I Services', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Parexel International Corp', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Development', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}