Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease
NCT ID: NCT00562887
Last Updated: 2011-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
246 participants
INTERVENTIONAL
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Placebo
every 4 weeks, IV
400 mg
ABT-874
400 mg IV every 4 weeks
700mg
ABT-874
700 mg IV every 4 weeks
Interventions
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Placebo
every 4 weeks, IV
ABT-874
400 mg IV every 4 weeks
ABT-874
700 mg IV every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
74 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Roberto Carcereri, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Ref # / Investigator 6792
Orange, California, United States
Site Ref # / Investigator 6643
San Diego, California, United States
Site Ref # / Investigator 6670
Hamden, Connecticut, United States
Site Ref # / Investigator 6694
Gainesville, Florida, United States
Site Ref # / Investigator 6794
Jacksonville, Florida, United States
Site Ref # / Investigator 6687
Winter Park, Florida, United States
Site Ref # / Investigator 6667
Zephyrhills, Florida, United States
Site Ref # / Investigator 6691
Atlanta, Georgia, United States
Site Ref # / Investigator 6642
Atlanta, Georgia, United States
Site Ref # / Investigator 8797
Macon, Georgia, United States
Site Ref # / Investigator 6925
Baton Rouge, Louisiana, United States
Site Ref # / Investigator 6865
Chevy Chase, Maryland, United States
Site Ref # / Investigator 10202
Towson, Maryland, United States
Site Ref # / Investigator 6866
Rochester, Minnesota, United States
Site Ref # / Investigator 6778
Mexico, Missouri, United States
Site Ref # / Investigator 7048
St Louis, Missouri, United States
Site Ref # / Investigator 7952
Las Vegas, Nevada, United States
Site Ref # / Investigator 6647
Cedar Knolls, New Jersey, United States
Site Ref # / Investigator 6689
Great Neck, New York, United States
Site Ref # / Investigator 6652
Lake Success, New York, United States
Site Ref # / Investigator 7047
New York, New York, United States
Site Ref # / Investigator 6693
Asheville, North Carolina, United States
Site Ref # / Investigator 6785
Charlotte, North Carolina, United States
Site Ref # / Investigator 9070
Morgantown, North Carolina, United States
Site Ref # / Investigator 6651
Raleigh, North Carolina, United States
Site Ref # / Investigator 6665
Beachwood, Ohio, United States
Site Ref # / Investigator 6690
Cincinnati, Ohio, United States
Site Ref # / Investigator 6786
Portland, Oregon, United States
Site Ref # / Investigator 7004
Germantown, Tennessee, 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 8357
Round Rock, Texas, United States
Site Ref # / Investigator 6688
Ogden, Utah, United States
Site Ref # / Investigator 9115
Chesapeake, Virginia, United States
Site Ref # / Investigator 6674
Seattle, Washington, United States
Site Ref # / Investigator 16983
Box Hill, Victoria, Australia
Site Ref # / Investigator 16225
Vienna, , Austria
Site Ref # / Investigator 16230
Bonheiden, , Belgium
Site Ref # / Investigator 16231
Leuven, , Belgium
Site Ref # / Investigator 9422
Calgary, Alberta, Canada
Site Ref # / Investigator 14042
Edmonton, Alberta, Canada
Site Ref # / Investigator 7610
Vancouver, British Columbia, Canada
Site Ref # / Investigator 8206
Winnipeg, Manitoba, Canada
Site Ref # / Investigator 7634
St. John's, Newfoundland and Labrador, 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 17901
Toronto, Ontario, Canada
Site Ref # / Investigator 7629
Montreal, Quebec, Canada
Site Ref # / Investigator 14702
Montreal, Quebec, Canada
Site Ref # / Investigator 15061
Montreal, Quebec, Canada
Site Ref # / Investigator 17881
Québec, Quebec, Canada
Site Ref # / Investigator 7642
Saskatoon, Saskatchewan, Canada
Site Ref # / Investigator 14821
Saskatoon, Saskatchewan, Canada
Site Ref # / Investigator 16985
Herlev, , Denmark
Site Ref # / Investigator 16235
Hvivdovre, , Denmark
Site Ref # / Investigator 16234
Odense C, , Denmark
Site Ref # / Investigator 10961
Ponce, , Puerto Rico
Site Ref # / Investigator 16801
San Juan, , Puerto Rico
Countries
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Other Identifiers
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2008-004919-36
Identifier Type: REGISTRY
Identifier Source: secondary_id
M10-222
Identifier Type: -
Identifier Source: org_study_id
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