Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease

Phase 2

Terminated

Conditions: Crohn's Disease

Interventions: Biological: Placebo
Biological: 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

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.

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
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Toronto, Ontario, Canada
Site Ref # / Investigator 6691
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Atlanta, Georgia, United States
Site Ref # / Investigator 6670
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Hamden, Connecticut, United States
Site Ref # / Investigator 6687
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Winter Park, Florida, United States
Site Ref # / Investigator 8797
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Macon, Georgia, United States
Site Ref # / Investigator 6642
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Atlanta, Georgia, United States
Site Ref # / Investigator 6778
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Mexico, Missouri, United States
Site Ref # / Investigator 8357
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Round Rock, Texas, United States
Site Ref # / Investigator 16231
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Leuven, Belgium
Site Ref # / Investigator 6694
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Gainesville, Florida, United States
Site Ref # / Investigator 10202
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Towson, Maryland, United States
Site Ref # / Investigator 16983
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Box Hill, Victoria, Australia
Site Ref # / Investigator 6665
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Beachwood, Ohio, United States
Site Ref # / Investigator 6689
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Great Neck, New York, United States
Site Ref # / Investigator 7634
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St. John's, Newfoundland and Labrador, Canada
Site Ref # / Investigator 6651
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Raleigh, North Carolina, United States
Site Ref # / Investigator 6688
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Ogden, Utah, United States
Site Ref # / Investigator 7004
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Germantown, Tennessee, United States
Site Ref # / Investigator 9422
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Calgary, Alberta, Canada
Site Ref # / Investigator 9070
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Morgantown, North Carolina, United States
Site Ref # / Investigator 7047
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New York, New York, United States
Site Ref # / Investigator 6647
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Cedar Knolls, New Jersey, United States
Site Ref # / Investigator 8206
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Winnipeg, Manitoba, Canada
Site Ref # / Investigator 6925
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Baton Rouge, Louisiana, United States
Site Ref # / Investigator 6667
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Zephyrhills, Florida, United States
Site Ref # / Investigator 6794
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Jacksonville, Florida, United States
Site Ref # / Investigator 6865
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Chevy Chase, Maryland, United States
Site Ref # / Investigator 6792
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Orange, California, United States
Site Ref # / Investigator 6693
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Asheville, North Carolina, United States
Site Ref # / Investigator 7048
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St. Louis, Missouri, United States
Site Ref # / Investigator 6652
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Lake Success, New York, United States
Site Ref # / Investigator 6785
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Charlotte, North Carolina, United States
Site Ref # / Investigator 9115
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Chesapeake, Virginia, United States
Site Ref # / Investigator 14042
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Edmonton, Alberta, Canada
Site Ref # / Investigator 7610
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Vancouver, British Columbia, Canada
Site Ref # / Investigator 7596
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Halifax, Nova Scotia, Canada
Site Ref # / Investigator 7630
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Truro, Nova Scotia, Canada
Site Ref # / Investigator 7641
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Hamilton, Ontario, Canada
Site Ref # / Investigator 10681
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London, Ontario, Canada
Site Ref # / Investigator 7629
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Montreal, Quebec, Canada
Site Ref # / Investigator 14702
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Montreal, Quebec, Canada
Site Ref # / Investigator 7642
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Saskatoon, Saskatchewan, Canada
Site Ref # / Investigator 14821
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Saskatoon, Saskatchewan, Canada
Site Ref # / Investigator 15061
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Montreal, Quebec, Canada
Site Ref # / Investigator 16985
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Herlev, Denmark
Site Ref # / Investigator 17881
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Quebec City, Quebec, Canada
Site Ref # / Investigator 16235
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Hvivdovre, Denmark
Site Ref # / Investigator 10961
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Ponce, Puerto Rico
Site Ref # / Investigator 16801
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San Juan, Puerto Rico
Site Ref # / Investigator 16234
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Odense C, Denmark
Site Ref # / Investigator 16230
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Bonheiden, Belgium
Site Ref # / Investigator 16225
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Vienna, Austria
Site Ref # / Investigator 6866
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Rochester, Minnesota, United States
Site Ref # / Investigator 7952
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Las Vegas, Nevada, United States
Site Ref # / Investigator 6690
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Cincinnati, Ohio, United States
Site Ref # / Investigator 6786
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Portland, Oregon, United States
Site Ref # / Investigator 6648
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Nashville, Tennessee, United States
Site Ref # / Investigator 6793
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Nashville, Tennessee, United States
Site Ref # / Investigator 7054
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Nashville, Tennessee, United States
Site Ref # / Investigator 6674
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Seattle, Washington, United States
Site Ref # / Investigator 6643
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San Diego, California, United States