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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Active Comparator |
| |
| Group 3 | Active Comparator |
| |
| Group 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus + pnemococcal vaccines alone | Drug | 0 mg + vaccines, Single dose, 28 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qutintiles Phase I Services | Lenexa | Kansas | United States | |||
| Parexel International Corp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17425783 | Derived | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D000069594 | Abatacept |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D018796 | Immunoconjugates |
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| Abatacept + vaccines |
| Drug |
Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days. |
|
|
| Abatacept + vaccines | Drug | Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days. |
|
|
| Abatacept + Vaccines | Drug | parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days. |
|
|
| Baltimore |
| Maryland |
| United States |
| PPD Development | Austin | Texas | United States |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000906 |
| Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |