Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004919-36 | Registry Identifier | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 400 mg | Experimental |
| |
| 700mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | every 4 weeks, IV |
| |
| ABT-874 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcomes, clinical response indicators, safety parameters | Weeks 12 and 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Roberto Carcereri, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 6792 | Orange | California | 92868 | United States | ||
| Site Ref # / Investigator 6643 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Biological |
400 mg IV every 4 weeks |
|
| ABT-874 | Biological | 700 mg IV every 4 weeks |
|
| San Diego |
| California |
| 92123 |
| United States |
| Site Ref # / Investigator 6670 | Hamden | Connecticut | 06518 | United States |
| Site Ref # / Investigator 6694 | Gainesville | Florida | 32610 | United States |
| Site Ref # / Investigator 6794 | Jacksonville | Florida | 32256 | United States |
| Site Ref # / Investigator 6687 | Winter Park | Florida | 32789 | United States |
| Site Ref # / Investigator 6667 | Zephyrhills | Florida | 33542 | United States |
| Site Ref # / Investigator 6691 | Atlanta | Georgia | 30308 | United States |
| Site Ref # / Investigator 6642 | Atlanta | Georgia | 30342 | United States |
| Site Ref # / Investigator 8797 | Macon | Georgia | 31201 | United States |
| Site Ref # / Investigator 6925 | Baton Rouge | Louisiana | 70809 | United States |
| Site Ref # / Investigator 6865 | Chevy Chase | Maryland | 20815 | United States |
| Site Ref # / Investigator 10202 | Towson | Maryland | 21204 | United States |
| Site Ref # / Investigator 6866 | Rochester | Minnesota | 55905 | United States |
| Site Ref # / Investigator 6778 | Mexico | Missouri | 65265 | United States |
| Site Ref # / Investigator 7048 | St Louis | Missouri | 63110 | United States |
| Site Ref # / Investigator 7952 | Las Vegas | Nevada | 89128 | United States |
| Site Ref # / Investigator 6647 | Cedar Knolls | New Jersey | 07927 | United States |
| Site Ref # / Investigator 6689 | Great Neck | New York | 11021 | United States |
| Site Ref # / Investigator 6652 | Lake Success | New York | 11042 | United States |
| Site Ref # / Investigator 7047 | New York | New York | 10029 | United States |
| Site Ref # / Investigator 6693 | Asheville | North Carolina | 28801 | United States |
| Site Ref # / Investigator 6785 | Charlotte | North Carolina | 28207 | United States |
| Site Ref # / Investigator 9070 | Morgantown | North Carolina | 28655 | United States |
| Site Ref # / Investigator 6651 | Raleigh | North Carolina | 27612 | United States |
| Site Ref # / Investigator 6665 | Beachwood | Ohio | 44122 | United States |
| Site Ref # / Investigator 6690 | Cincinnati | Ohio | 45219 | United States |
| Site Ref # / Investigator 6786 | Portland | Oregon | 97220 | United States |
| Site Ref # / Investigator 7004 | Germantown | Tennessee | 38138 | United States |
| Site Ref # / Investigator 6648 | Nashville | Tennessee | 37203 | United States |
| Site Ref # / Investigator 6793 | Nashville | Tennessee | 37205 | United States |
| Site Ref # / Investigator 7054 | Nashville | Tennessee | 37212-1610 | United States |
| Site Ref # / Investigator 8357 | Round Rock | Texas | 78681 | United States |
| Site Ref # / Investigator 6688 | Ogden | Utah | 84405 | United States |
| Site Ref # / Investigator 9115 | Chesapeake | Virginia | 23320 | United States |
| Site Ref # / Investigator 6674 | Seattle | Washington | 98195 | United States |
| Site Ref # / Investigator 16983 | Box Hill | Victoria | 3128 | Australia |
| Site Ref # / Investigator 16225 | Vienna | 1090 | Austria |
| Site Ref # / Investigator 16230 | Bonheiden | 2820 | Belgium |
| Site Ref # / Investigator 16231 | Leuven | 3000 | Belgium |
| Site Ref # / Investigator 9422 | Calgary | Alberta | T2N 4Z6 | Canada |
| Site Ref # / Investigator 14042 | Edmonton | Alberta | T6G 2X8 | Canada |
| Site Ref # / Investigator 7610 | Vancouver | British Columbia | V6Z-2K5 | Canada |
| Site Ref # / Investigator 8206 | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Site Ref # / Investigator 7634 | St. John's | Newfoundland and Labrador | A1B - 3V6 | Canada |
| Site Ref # / Investigator 7596 | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Site Ref # / Investigator 7630 | Truro | Nova Scotia | B2N 1L2 | Canada |
| Site Ref # / Investigator 7641 | Hamilton | Ontario | L8N 3Z5 | Canada |
| Site Ref # / Investigator 10681 | London | Ontario | N6A 5K8 | Canada |
| Site Ref # / Investigator 17901 | Toronto | Ontario | M5G 1X5 | Canada |
| Site Ref # / Investigator 7629 | Montreal | Quebec | H1T 2M4 | Canada |
| Site Ref # / Investigator 14702 | Montreal | Quebec | H3A 1A1 | Canada |
| Site Ref # / Investigator 15061 | Montreal | Quebec | H3T 1E2 | Canada |
| Site Ref # / Investigator 17881 | Québec | Quebec | G1R 2J6 | Canada |
| Site Ref # / Investigator 7642 | Saskatoon | Saskatchewan | S7K 1N4 | Canada |
| Site Ref # / Investigator 14821 | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Site Ref # / Investigator 16985 | Herlev | DK-2730 | Denmark |
| Site Ref # / Investigator 16235 | Hvivdovre | 2650 | Denmark |
| Site Ref # / Investigator 16234 | Odense C | 5000 | Denmark |
| Site Ref # / Investigator 10961 | Ponce | 00717 | Puerto Rico |
| Site Ref # / Investigator 16801 | San Juan | 00935 | Puerto Rico |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C544528 | briakinumab |
Not provided
Not provided
Not provided