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To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Blind | Placebo Comparator |
| |
| Open Label | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | 80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood samples for Influenza A & B antibody Assay | Baseline (Day 1), Day 36 or premature discontinuation | |
| Blood Samples for Pneumococcal Antibody Assay | Baseline (Day 1), Day 36 or premature discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory assessments | Screening, Week 15, Day 36, Month 3 and Month 6 | |
| Vitals signs | Screening - Month 6 | |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27338778 | Derived | Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23. |
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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 |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| placebo | Biological | 2 injections Day 1, 1 injection Days 15 and 29 |
|
| adalimumab | Biological | 40 mg adalimumab every other week |
|
|
| Screening - Month 6 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |