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Sponsored by: |
Bristol-Myers Squibb |
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00279734 |
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.
Condition | Intervention | Phase |
Rheumatoid Arthritis |
Drug: Tetanus + pnemococcal vaccines alone Drug: Abatacept + vaccines Drug: Abatacept + Vaccines |
Phase I |
MedlinePlus related topics: | Rheumatoid Arthritis Tetanus |
Drug Information available for: | Tetanus Vaccine Abatacept |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | 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 |
Estimated Enrollment: | 80 |
Study Start Date: | August 2004 |
Arms | Assigned Interventions |
Group 1: Experimental |
Drug: Tetanus + pnemococcal vaccines alone
0 mg + vaccines, Single dose, 28 days.
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Group 2: Active Comparator |
Drug: Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.
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Group 3: Active Comparator |
Drug: Abatacept + vaccines
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.
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Group 4: Active Comparator |
Drug: Abatacept + Vaccines
parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |||||
Qutintiles Phase I Services | |||||
Lenexa, Kansas, United States | |||||
United States, Maryland | |||||
Parexel International Corp | |||||
Baltimore, Maryland, United States | |||||
United States, Texas | |||||
PPD Development | |||||
Austin, Texas, United States |
Bristol-Myers Squibb |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
BMS Clinical Trials Disclosure 
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For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm 
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Study ID Numbers: | IM101-049 |
First Received: | January 19, 2006 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00279734 |
Health Authority: | United States: Food and Drug Administration |
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