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Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to patients with active, stable, moderate to severe rheumatoid arthritis (RA).
It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control in subjects with RA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XOMA 052 | Drug | A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events. | Day 0 pre-dose through Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessments from serum samples collected at time points specified in the protocol. | Day 0 Pre-dose through Day 56 | |
| Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol. | Day 0 pre-dose through Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Solinger, M.D. | XOMA (US) LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearwater | Florida | 33765 | United States | |||
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C547697 | gevokizumab |
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| Placebo | Drug | A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection. |
|
| Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol. | Day 0 pre-dose through Day 56 |
| Middleburg Heights |
| Ohio |
| 44130 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |