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This study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (Crohn's Disease).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 683699 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who are responders at Week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| - Proportion of subjects with response at other timepoints. - Proportion of subjects in remission. - Average rate of response for the CDAI score. - Mean change from baseline in CDAI score Improvement in Quality of Life. |
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Inclusion criteria:
Exclusion criteria:
Permitted medications:
Prohibited medications:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Garden Grove | California | 92840 | United States | ||
| GSK Investigational Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 31, 2017 | |
| Reset | Jun 15, 2017 | |
| Release | Jun 29, 2017 |
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| Roseville |
| California |
| 95661 |
| United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Topeka | Kansas | 66614 | United States |
| GSK Investigational Site | West Yarmouth | Massachusetts | 02673 | United States |
| GSK Investigational Site | Great Neck | New York | 11021 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28211 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27612 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45219 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38120 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Calgary | Alberta | T2N 4N1 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3N 2V7 | Canada |
| GSK Investigational Site | Windsor | Ontario | N8X 5A6 | Canada |
| GSK Investigational Site | Lévis | Quebec | G6V 3Z1 | Canada |
| GSK Investigational Site | Québec | Quebec | G1S 4L8 | Canada |
| GSK Investigational Site | Saskatoon | Saskatchewan | S7K 1J5 | Canada |
| Reset | Jan 26, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2017 | Jun 15, 2017 | |||
| Jun 29, 2017 | Jan 26, 2018 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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