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Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | BIIB023 |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB023 | Drug | Single IV doses of BIIB023 in dose-escalating cohorts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA. | Baseline through Day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| • Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects | Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anniston | Alabama | United States | |||
| Research Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23928094 | Derived | Wisniacki N, Amaravadi L, Galluppi GR, Zheng TS, Zhang R, Kong J, Burkly LC. Safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-TWEAK monoclonal antibody in patients with rheumatoid arthritis. Clin Ther. 2013 Aug;35(8):1137-49. doi: 10.1016/j.clinthera.2013.06.008. Epub 2013 Aug 6. |
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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 |
|---|---|
| C586995 | BIIB023 |
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| Placebo (sterile normal saline) | Other | Single IV dose of Placebo |
|
| Palm Desert |
| California |
| United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Centre | Duncansville | Pennsylvania | United States |
| Research Centre | Moscow | Russia |
| Research Centre | Yaroslavl | Russia |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |