Crohn's Disease Clinical Trial
Official title:
A Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease.
To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.
| Status | Terminated |
| Enrollment | 246 |
| Est. completion date | |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 74 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of Crohn's disease for greater than 4 months confirmed by endoscopy or radiologic evaluation. - CDAI score of >= 220 and <= 450 at Week 0. - Males and females >= 18 years and < 75 years of age at the Screening visit. - Judged to be in generally good health as determined by the Investigator. Exclusion Criteria: - Current diagnosis of the colitis other than Crohn's disease. - Symptomatic known strictures. - Surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study. - Ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded). - Short bowel syndrome as determined by the investigator. - Infection or risk factors for severe infections. - Females who are pregnant or considering becoming pregnant during the study, or breast-feeding. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Site Ref # / Investigator 16983 | Box Hill | Victoria |
| Austria | Site Ref # / Investigator 16225 | Vienna | |
| Belgium | Site Ref # / Investigator 16230 | Bonheiden | |
| Belgium | Site Ref # / Investigator 16231 | Leuven | |
| Canada | Site Ref # / Investigator 9422 | Calgary | Alberta |
| Canada | Site Ref # / Investigator 14042 | Edmonton | Alberta |
| Canada | Site Ref # / Investigator 7596 | Halifax | Nova Scotia |
| Canada | Site Ref # / Investigator 7641 | Hamilton | Ontario |
| Canada | Site Ref # / Investigator 10681 | London | Ontario |
| Canada | Site Ref # / Investigator 14702 | Montreal | Quebec |
| Canada | Site Ref # / Investigator 15061 | Montreal | Quebec |
| Canada | Site Ref # / Investigator 7629 | Montreal | Quebec |
| Canada | Site Ref # / Investigator 17881 | Quebec City | Quebec |
| Canada | Site Ref # / Investigator 14821 | Saskatoon | Saskatchewan |
| Canada | Site Ref # / Investigator 7642 | Saskatoon | Saskatchewan |
| Canada | Site Ref # / Investigator 7634 | St. John's | Newfoundland and Labrador |
| Canada | Site Ref # / Investigator 17901 | Toronto | Ontario |
| Canada | Site Ref # / Investigator 7630 | Truro | Nova Scotia |
| Canada | Site Ref # / Investigator 7610 | Vancouver | British Columbia |
| Canada | Site Ref # / Investigator 8206 | Winnipeg | Manitoba |
| Denmark | Site Ref # / Investigator 16985 | Herlev | |
| Denmark | Site Ref # / Investigator 16235 | Hvivdovre | |
| Denmark | Site Ref # / Investigator 16234 | Odense C | |
| Puerto Rico | Site Ref # / Investigator 10961 | Ponce | |
| Puerto Rico | Site Ref # / Investigator 16801 | San Juan | |
| United States | Site Ref # / Investigator 6693 | Asheville | North Carolina |
| United States | Site Ref # / Investigator 6642 | Atlanta | Georgia |
| United States | Site Ref # / Investigator 6691 | Atlanta | Georgia |
| United States | Site Ref # / Investigator 6925 | Baton Rouge | Louisiana |
| United States | Site Ref # / Investigator 6665 | Beachwood | Ohio |
| United States | Site Ref # / Investigator 6647 | Cedar Knolls | New Jersey |
| United States | Site Ref # / Investigator 6785 | Charlotte | North Carolina |
| United States | Site Ref # / Investigator 9115 | Chesapeake | Virginia |
| United States | Site Ref # / Investigator 6865 | Chevy Chase | Maryland |
| United States | Site Ref # / Investigator 6690 | Cincinnati | Ohio |
| United States | Site Ref # / Investigator 6694 | Gainesville | Florida |
| United States | Site Ref # / Investigator 7004 | Germantown | Tennessee |
| United States | Site Ref # / Investigator 6689 | Great Neck | New York |
| United States | Site Ref # / Investigator 6670 | Hamden | Connecticut |
| United States | Site Ref # / Investigator 6794 | Jacksonville | Florida |
| United States | Site Ref # / Investigator 6652 | Lake Success | New York |
| United States | Site Ref # / Investigator 7952 | Las Vegas | Nevada |
| United States | Site Ref # / Investigator 8797 | Macon | Georgia |
| United States | Site Ref # / Investigator 6778 | Mexico | Missouri |
| United States | Site Ref # / Investigator 9070 | Morgantown | North Carolina |
| United States | Site Ref # / Investigator 6648 | Nashville | Tennessee |
| United States | Site Ref # / Investigator 6793 | Nashville | Tennessee |
| United States | Site Ref # / Investigator 7054 | Nashville | Tennessee |
| United States | Site Ref # / Investigator 7047 | New York | New York |
| United States | Site Ref # / Investigator 6688 | Ogden | Utah |
| United States | Site Ref # / Investigator 6792 | Orange | California |
| United States | Site Ref # / Investigator 6786 | Portland | Oregon |
| United States | Site Ref # / Investigator 6651 | Raleigh | North Carolina |
| United States | Site Ref # / Investigator 6866 | Rochester | Minnesota |
| United States | Site Ref # / Investigator 8357 | Round Rock | Texas |
| United States | Site Ref # / Investigator 6643 | San Diego | California |
| United States | Site Ref # / Investigator 6674 | Seattle | Washington |
| United States | Site Ref # / Investigator 7048 | St. Louis | Missouri |
| United States | Site Ref # / Investigator 10202 | Towson | Maryland |
| United States | Site Ref # / Investigator 6687 | Winter Park | Florida |
| United States | Site Ref # / Investigator 6667 | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States, Australia, Austria, Belgium, Canada, Denmark, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points | Week 6 | No | |
| Secondary | Patient reported outcomes, clinical response indicators, safety parameters | Weeks 12 and 24 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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