Clinical trial NCT00562887: Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-11-26
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
timeFrame: Week 6
Secondary outcomes:
measure: Patient reported outcomes, clinical response indicators, safety parameters
timeFrame: Weeks 12 and 24
Other outcomes:
Locations:
city: Orange
country: United States
facility: Site Ref # / Investigator 6792
state: California
city: San Diego
country: United States
facility: Site Ref # / Investigator 6643
state: California
city: Hamden
country: United States
facility: Site Ref # / Investigator 6670
state: Connecticut
city: Gainesville
country: United States
facility: Site Ref # / Investigator 6694
state: Florida
city: Jacksonville
country: United States
facility: Site Ref # / Investigator 6794
state: Florida
city: Winter Park
country: United States
facility: Site Ref # / Investigator 6687
state: Florida
city: Zephyrhills
country: United States
facility: Site Ref # / Investigator 6667
state: Florida
city: Atlanta
country: United States
facility: Site Ref # / Investigator 6691
state: Georgia
city: Atlanta
country: United States
facility: Site Ref # / Investigator 6642
state: Georgia
city: Macon
country: United States
facility: Site Ref # / Investigator 8797
state: Georgia
city: Baton Rouge
country: United States
facility: Site Ref # / Investigator 6925
state: Louisiana
city: Chevy Chase
country: United States
facility: Site Ref # / Investigator 6865
state: Maryland
city: Towson
country: United States
facility: Site Ref # / Investigator 10202
state: Maryland
city: Rochester
country: United States
facility: Site Ref # / Investigator 6866
state: Minnesota
city: Mexico
country: United States
facility: Site Ref # / Investigator 6778
state: Missouri
city: St. Louis
country: United States
facility: Site Ref # / Investigator 7048
state: Missouri
city: Las Vegas
country: United States
facility: Site Ref # / Investigator 7952
state: Nevada
city: Cedar Knolls
country: United States
facility: Site Ref # / Investigator 6647
state: New Jersey
city: Great Neck
country: United States
facility: Site Ref # / Investigator 6689
state: New York
city: Lake Success
country: United States
facility: Site Ref # / Investigator 6652
state: New York
city: New York
country: United States
facility: Site Ref # / Investigator 7047
state: New York
city: Asheville
country: United States
facility: Site Ref # / Investigator 6693
state: North Carolina
city: Charlotte
country: United States
facility: Site Ref # / Investigator 6785
state: North Carolina
city: Morgantown
country: United States
facility: Site Ref # / Investigator 9070
state: North Carolina
city: Raleigh
country: United States
facility: Site Ref # / Investigator 6651
state: North Carolina
city: Beachwood
country: United States
facility: Site Ref # / Investigator 6665
state: Ohio
city: Cincinnati
country: United States
facility: Site Ref # / Investigator 6690
state: Ohio
city: Portland
country: United States
facility: Site Ref # / Investigator 6786
state: Oregon
city: Germantown
country: United States
facility: Site Ref # / Investigator 7004
state: Tennessee
city: Nashville
country: United States
facility: Site Ref # / Investigator 6648
state: Tennessee
city: Nashville
country: United States
facility: Site Ref # / Investigator 6793
state: Tennessee
city: Nashville
country: United States
facility: Site Ref # / Investigator 7054
state: Tennessee
city: Round Rock
country: United States
facility: Site Ref # / Investigator 8357
state: Texas
city: Ogden
country: United States
facility: Site Ref # / Investigator 6688
state: Utah
city: Chesapeake
country: United States
facility: Site Ref # / Investigator 9115
state: Virginia
city: Seattle
country: United States
facility: Site Ref # / Investigator 6674
state: Washington
city: Box Hill
country: Australia
facility: Site Ref # / Investigator 16983
state: Victoria
city: Vienna
country: Austria
facility: Site Ref # / Investigator 16225
city: Bonheiden
country: Belgium
facility: Site Ref # / Investigator 16230
city: Leuven
country: Belgium
facility: Site Ref # / Investigator 16231
city: Calgary
country: Canada
facility: Site Ref # / Investigator 9422
state: Alberta
city: Edmonton
country: Canada
facility: Site Ref # / Investigator 14042
state: Alberta
city: Vancouver
country: Canada
facility: Site Ref # / Investigator 7610
state: British Columbia
city: Winnipeg
country: Canada
facility: Site Ref # / Investigator 8206
state: Manitoba
city: St. John's
country: Canada
facility: Site Ref # / Investigator 7634
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Site Ref # / Investigator 7596
state: Nova Scotia
city: Truro
country: Canada
facility: Site Ref # / Investigator 7630
state: Nova Scotia
city: Hamilton
country: Canada
facility: Site Ref # / Investigator 7641
state: Ontario
city: London
country: Canada
facility: Site Ref # / Investigator 10681
state: Ontario
city: Toronto
country: Canada
facility: Site Ref # / Investigator 17901
state: Ontario
city: Montreal
country: Canada
facility: Site Ref # / Investigator 7629
state: Quebec
city: Montreal
country: Canada
facility: Site Ref # / Investigator 14702
state: Quebec
city: Montreal
country: Canada
facility: Site Ref # / Investigator 15061
state: Quebec
city: Quebec City
country: Canada
facility: Site Ref # / Investigator 17881
state: Quebec
city: Saskatoon
country: Canada
facility: Site Ref # / Investigator 7642
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Site Ref # / Investigator 14821
state: Saskatchewan
city: Herlev
country: Denmark
facility: Site Ref # / Investigator 16985
city: Hvivdovre
country: Denmark
facility: Site Ref # / Investigator 16235
city: Odense C
country: Denmark
facility: Site Ref # / Investigator 16234
city: Ponce
country: Puerto Rico
facility: Site Ref # / Investigator 10961
city: San Juan
country: Puerto Rico
facility: Site Ref # / Investigator 16801
Study officials:
affiliation: Abbott
name: Roberto Carcereri, MD
role: STUDY_DIRECTOR
References: