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The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 196 subjects |
|
| 3 | Experimental | 196 subjects |
|
| 2 | Experimental | 196 subjects |
|
| 4 | Placebo Comparator | 196 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 108 | Drug | 50mg via SC (subcutaneous) injection every 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 response | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subject reported outcomes | 24 Weeks | |
| ACRn, AUC ACRn, ACR50, ACR70, and DAS28 | 24 Weeks | |
| PK parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20950476 | Derived | Cardiel MH, Tak PP, Bensen W, Burch FX, Forejtova S, Badurski JE, Kakkar T, Bevirt T, Ni L, McCroskery E, Jahreis A, Zack DJ. A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis. Arthritis Res Ther. 2010;12(5):R192. doi: 10.1186/ar3163. Epub 2010 Oct 15. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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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 |
|---|---|
| C557018 | AMG 108 |
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| AMG 108 |
| Drug |
250mg via SC (subcutaneous) injection every 4 weeks |
|
| AMG 108 | Drug | 125mg via SC (subcutaneous) injection every 4 weeks |
|
| Placebo | Drug | Placebo via SC (subcutaneous) injection every 4 weeks |
|
| 24 Weeks |
| Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status | 24 Weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |