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| ID | Type | Description | Link |
|---|---|---|---|
| B2261002 |
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| Name | Class |
|---|---|
| Emergent Product Development Seattle LLC | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBI-087 0.15 mg IV | Experimental |
| |
| SBI-087 0.5 mg IV | Experimental |
| |
| SBI-087 100 mg SC | Experimental |
| |
| SBI-087 200 mg SC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBI-087 | Drug | IV, Single dose |
| |
| SBI-087 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as determined by the number and severity of adverse events at the different dose levels | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA | 12 months | |
| To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ehime | Japan | ||||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | 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 |
|---|---|
| C000622592 | SBI-087 |
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| Drug |
IV, Single dose |
|
| SBI-087 | Drug | SC, Single dose |
|
| SBI-087 | Drug | SC, Single dose |
|
| 12 month |
| To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087 | 12 month |
| Fukui |
| Japan |
| Pfizer Investigational Site | Kanagawa | Japan |
| Pfizer Investigational Site | Miyagi | Japan |
| Pfizer Investigational Site | Ōita | Japan |
| Pfizer Investigational Site | Shizuoka | Japan |
| Pfizer Investigational Site | Tokyo | Japan |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |