Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease
- Conditions
- Crohn's Disease
- Interventions
- Biological: PlaceboBiological: ABT-874
- Registration Number
- NCT00562887
- Lead Sponsor
- Abbott
- Brief Summary
To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 246
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo - 400 mg ABT-874 - 700mg ABT-874 -
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points Week 6
- Secondary Outcome Measures
Name Time Method Patient reported outcomes, clinical response indicators, safety parameters Weeks 12 and 24
Trial Locations
- Locations (61)
Site Ref # / Investigator 17901
🇨🇦Toronto, Ontario, Canada
Site Ref # / Investigator 6691
🇺🇸Atlanta, Georgia, United States
Site Ref # / Investigator 6670
🇺🇸Hamden, Connecticut, United States
Site Ref # / Investigator 6687
🇺🇸Winter Park, Florida, United States
Site Ref # / Investigator 8797
🇺🇸Macon, Georgia, United States
Site Ref # / Investigator 6642
🇺🇸Atlanta, Georgia, United States
Site Ref # / Investigator 6778
🇺🇸Mexico, Missouri, United States
Site Ref # / Investigator 8357
🇺🇸Round Rock, Texas, United States
Site Ref # / Investigator 16231
🇧🇪Leuven, Belgium
Site Ref # / Investigator 6694
🇺🇸Gainesville, Florida, United States
Site Ref # / Investigator 10202
🇺🇸Towson, Maryland, United States
Site Ref # / Investigator 16983
🇦🇺Box Hill, Victoria, Australia
Site Ref # / Investigator 6665
🇺🇸Beachwood, Ohio, United States
Site Ref # / Investigator 6689
🇺🇸Great Neck, New York, United States
Site Ref # / Investigator 7634
🇨🇦St. John's, Newfoundland and Labrador, Canada
Site Ref # / Investigator 6651
🇺🇸Raleigh, North Carolina, United States
Site Ref # / Investigator 6688
🇺🇸Ogden, Utah, United States
Site Ref # / Investigator 7004
🇺🇸Germantown, Tennessee, United States
Site Ref # / Investigator 9422
🇨🇦Calgary, Alberta, Canada
Site Ref # / Investigator 9070
🇺🇸Morgantown, North Carolina, United States
Site Ref # / Investigator 7047
🇺🇸New York, New York, United States
Site Ref # / Investigator 6647
🇺🇸Cedar Knolls, New Jersey, United States
Site Ref # / Investigator 8206
🇨🇦Winnipeg, Manitoba, Canada
Site Ref # / Investigator 6925
🇺🇸Baton Rouge, Louisiana, United States
Site Ref # / Investigator 6667
🇺🇸Zephyrhills, Florida, United States
Site Ref # / Investigator 6794
🇺🇸Jacksonville, Florida, United States
Site Ref # / Investigator 6865
🇺🇸Chevy Chase, Maryland, United States
Site Ref # / Investigator 6792
🇺🇸Orange, California, United States
Site Ref # / Investigator 6693
🇺🇸Asheville, North Carolina, United States
Site Ref # / Investigator 7048
🇺🇸St. Louis, Missouri, United States
Site Ref # / Investigator 6652
🇺🇸Lake Success, New York, United States
Site Ref # / Investigator 6785
🇺🇸Charlotte, North Carolina, United States
Site Ref # / Investigator 9115
🇺🇸Chesapeake, Virginia, United States
Site Ref # / Investigator 14042
🇨🇦Edmonton, Alberta, Canada
Site Ref # / Investigator 7610
🇨🇦Vancouver, British Columbia, Canada
Site Ref # / Investigator 7596
🇨🇦Halifax, Nova Scotia, Canada
Site Ref # / Investigator 7630
🇨🇦Truro, Nova Scotia, Canada
Site Ref # / Investigator 7641
🇨🇦Hamilton, Ontario, Canada
Site Ref # / Investigator 10681
🇨🇦London, Ontario, Canada
Site Ref # / Investigator 7629
🇨🇦Montreal, Quebec, Canada
Site Ref # / Investigator 14702
🇨🇦Montreal, Quebec, Canada
Site Ref # / Investigator 7642
🇨🇦Saskatoon, Saskatchewan, Canada
Site Ref # / Investigator 14821
🇨🇦Saskatoon, Saskatchewan, Canada
Site Ref # / Investigator 15061
🇨🇦Montreal, Quebec, Canada
Site Ref # / Investigator 16985
🇩🇰Herlev, Denmark
Site Ref # / Investigator 17881
🇨🇦Quebec City, Quebec, Canada
Site Ref # / Investigator 16235
🇩🇰Hvivdovre, Denmark
Site Ref # / Investigator 10961
🇵🇷Ponce, Puerto Rico
Site Ref # / Investigator 16801
🇵🇷San Juan, Puerto Rico
Site Ref # / Investigator 16234
🇩🇰Odense C, Denmark
Site Ref # / Investigator 16230
🇧🇪Bonheiden, Belgium
Site Ref # / Investigator 16225
🇦🇹Vienna, Austria
Site Ref # / Investigator 6866
🇺🇸Rochester, Minnesota, United States
Site Ref # / Investigator 7952
🇺🇸Las Vegas, Nevada, United States
Site Ref # / Investigator 6690
🇺🇸Cincinnati, Ohio, United States
Site Ref # / Investigator 6786
🇺🇸Portland, Oregon, 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 6674
🇺🇸Seattle, Washington, United States
Site Ref # / Investigator 6643
🇺🇸San Diego, California, United States