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This is a Phase I multicenter study that will be conducted in the United States and Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Intravenous and subcutaneous ascending dose |
| |
| PRO283698 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of PRO283698 assessed through the incidence of adverse events | Through study completion or early study discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | Following study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| June Lee, M.D. | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Anniston | Alabama | 36207 | United States | ||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22225620 | Derived | Emu B, Luca D, Offutt C, Grogan JL, Rojkovich B, Williams MB, Tang MT, Xiao J, Lee JH, Davis JC. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin alpha: results of a phase I randomized, placebo-controlled trial. Arthritis Res Ther. 2012 Jan 8;14(1):R6. doi: 10.1186/ar3554. |
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| Drug |
Intravenous and subcutaneous ascending dose |
|
| Orlando |
| Florida |
| 32804 |
| United States |
| Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Investigational Site | Palm Harbor | Florida | 34684 | United States |
| Investigational Site | Idaho Falls | Idaho | 83404 | United States |
| Investigational Site | Indianapolis | Indiana | 46227 | United States |
| Investigational Site | Frederick | Maryland | 21702 | United States |
| Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Investigational Site | Budapest | 1027 | Hungary |
| Investigational Site | Debrecen | 4043 | Hungary |
| Investigational Site | Szeged | 6720 | Hungary |
| 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 |
|---|---|
| C576689 | pateclizumab |
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