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| Name | Class |
|---|---|
| Eisai Limited | INDUSTRY |
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The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg | Experimental | 20 mg adalimumab eow |
|
| 40 mg | Experimental | 40 mg adalimumab eow |
|
| 80 mg | Experimental | 80 mg adalimumab eow |
|
| Placebo | Placebo Comparator | Placebo eow |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | 20 mg sc eow |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 | Week12 | |
| ACR50 | Weeks 12 and 24 | |
| ACR70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeki Hashimoto, Ph.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi | Japan | |||||
| 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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| adalimumab | Biological | 40 mg sc eow |
|
|
| adalimumab | Biological | 80 mg sc eow |
|
|
| placebo | Biological | placebo sc eow |
|
| Weeks 12 and 24 |
| Chiba |
| Japan |
| Ehime | Japan |
| Fukui | Japan |
| Fukuoka | Japan |
| Gunma | Japan |
| Hokkaido | Japan |
| Hyōgo | Japan |
| Ibaraki | Japan |
| Ishikawa | Japan |
| Kagoshima | Japan |
| Kanagawa | Japan |
| Kyoto | Japan |
| Miyagi | Japan |
| Nagano | Japan |
| Nagasaki | Japan |
| Niigata | Japan |
| Okayama | Japan |
| Osaka | Japan |
| Saitama | Japan |
| Shizuoka | Japan |
| Tochigi | Japan |
| Tokushima | Japan |
| Tokyo | Japan |
| Toyama | Japan |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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