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The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-681323 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of CRP at other available timepoints. The following secondary endpoints will be analysed at all available timepoints: Clinical Symptoms, Safety and Biomarkers, Health Outcome. | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hvidovre | 2650 | Denmark | |||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 19, 2017 | |
| Reset | Jan 24, 2018 | |
| Release | Mar 14, 2018 |
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| Augsburg |
| Bavaria |
| 86179 |
| Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 20249 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22081 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60433 | Germany |
| GSK Investigational Site | Hofheim | Hesse | 65719 | Germany |
| GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| GSK Investigational Site | Halle | Saxony-Anhalt | 06120 | Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23538 | Germany |
| GSK Investigational Site | Shatin | Hong Kong |
| GSK Investigational Site | Foggia | Apulia | 71100 | Italy |
| GSK Investigational Site | Benevento | Campania | 82100 | Italy |
| GSK Investigational Site | Telese Terme (BN) | Campania | 82100 | Italy |
| GSK Investigational Site | Jesi (AN) | The Marches | 60035 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56126 | Italy |
| GSK Investigational Site | Drammen | N-3004 | Norway |
| GSK Investigational Site | Lillehammer | 2609 | Norway |
| GSK Investigational Site | Oslo | N-0027 | Norway |
| GSK Investigational Site | Oslo | N-0370 | Norway |
| GSK Investigational Site | Sarpsborg | N-1723 | Norway |
| GSK Investigational Site | Stavanger | N-4011 | Norway |
| GSK Investigational Site | Tønsberg | N-3117 | Norway |
| GSK Investigational Site | Grudziądz | 86-300 | Poland |
| GSK Investigational Site | Warsaw | 02-341 | Poland |
| GSK Investigational Site | Wroclaw | 50-088 | Poland |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Baracaldo/Vizcaya | 48903 | Spain |
| GSK Investigational Site | Granada | 18014 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Mérida | 6800 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15706 | Spain |
| GSK Investigational Site | Seville | 41071 | Spain |
| GSK Investigational Site | Valencia | 46017 | Spain |
| GSK Investigational Site | Gothenburg | SE-431 45 | Sweden |
| GSK Investigational Site | Luleå | SE-972 33 | Sweden |
| GSK Investigational Site | Wigan | Lancashire | WN6 9EP | United Kingdom |
| GSK Investigational Site | Metropolitan Borough of Wirral | Merseyside | CH49 9PE | United Kingdom |
| GSK Investigational Site | Edinburgh | Midlothian | EH4 2XU | United Kingdom |
| GSK Investigational Site | London | SE1 9RT | United Kingdom |
| GSK Investigational Site | Sheffield | S10 2JF | United Kingdom |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2017 | Jan 24, 2018 | |||
| Mar 14, 2018 | Aug 15, 2018 |
| 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 |
|---|---|
| C574213 | dilmapimod |
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