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Study has stopped due to a decision by Amgen to terminate the program
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The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 357 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 357 | Drug | Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| AMG 357 pharmacokinetic profile (eg, plasma concentration, maximum observed concentration [Cmax], time at Cmax [Tmax], and area under the concentration-time curve [AUC]) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Duncansville | Pennsylvania | 16635 | United States | ||
| Research Site |
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| 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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| Placebo | Drug | Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets. |
|
| Dallas |
| Texas |
| 75231 |
| United States |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |