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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00562887
First received: November 21, 2007
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.


Condition Intervention Phase
Crohn's Disease
Biological: Placebo
Biological: ABT-874
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported outcomes, clinical response indicators, safety parameters [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: November 2007
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Biological: Placebo
every 4 weeks, IV
Other Name: placebo
Experimental: 400 mg Biological: ABT-874
400 mg IV every 4 weeks
Other Name: ABT-874
Experimental: 700mg Biological: ABT-874
700 mg IV every 4 weeks
Other Name: ABT-874

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562887

  Hide Study Locations
Locations
United States, California
Site Ref # / Investigator 6792
Orange, California, United States, 92868
Site Ref # / Investigator 6643
San Diego, California, United States, 92123
United States, Connecticut
Site Ref # / Investigator 6670
Hamden, Connecticut, United States, 06518
United States, Florida
Site Ref # / Investigator 6694
Gainesville, Florida, United States, 32610
Site Ref # / Investigator 6794
Jacksonville, Florida, United States, 32256
Site Ref # / Investigator 6687
Winter Park, Florida, United States, 32789
Site Ref # / Investigator 6667
Zephyrhills, Florida, United States, 33542
United States, Georgia
Site Ref # / Investigator 6642
Atlanta, Georgia, United States, 30342
Site Ref # / Investigator 6691
Atlanta, Georgia, United States, 30308
Site Ref # / Investigator 8797
Macon, Georgia, United States, 31201
United States, Louisiana
Site Ref # / Investigator 6925
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Site Ref # / Investigator 6865
Chevy Chase, Maryland, United States, 20815
Site Ref # / Investigator 10202
Towson, Maryland, United States, 21204
United States, Minnesota
Site Ref # / Investigator 6866
Rochester, Minnesota, United States, 55905
United States, Missouri
Site Ref # / Investigator 6778
Mexico, Missouri, United States, 65265
Site Ref # / Investigator 7048
St. Louis, Missouri, United States, 63110
United States, Nevada
Site Ref # / Investigator 7952
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Site Ref # / Investigator 6647
Cedar Knolls, New Jersey, United States, 07927
United States, New York
Site Ref # / Investigator 6689
Great Neck, New York, United States, 11021
Site Ref # / Investigator 6652
Lake Success, New York, United States, 11042
Site Ref # / Investigator 7047
New York, New York, United States, 10029
United States, North Carolina
Site Ref # / Investigator 6693
Asheville, North Carolina, United States, 28801
Site Ref # / Investigator 6785
Charlotte, North Carolina, United States, 28207
Site Ref # / Investigator 9070
Morgantown, North Carolina, United States, 28655
Site Ref # / Investigator 6651
Raleigh, North Carolina, United States, 27612
United States, Ohio
Site Ref # / Investigator 6665
Beachwood, Ohio, United States, 44122
Site Ref # / Investigator 6690
Cincinnati, Ohio, United States, 45219
United States, Oregon
Site Ref # / Investigator 6786
Portland, Oregon, United States, 97220
United States, Tennessee
Site Ref # / Investigator 7004
Germantown, Tennessee, United States, 38138
Site Ref # / Investigator 7054
Nashville, Tennessee, United States, 37212-1610
Site Ref # / Investigator 6648
Nashville, Tennessee, United States, 37203
Site Ref # / Investigator 6793
Nashville, Tennessee, United States, 37205
United States, Texas
Site Ref # / Investigator 8357
Round Rock, Texas, United States, 78681
United States, Utah
Site Ref # / Investigator 6688
Ogden, Utah, United States, 84405
United States, Virginia
Site Ref # / Investigator 9115
Chesapeake, Virginia, United States, 23320
United States, Washington
Site Ref # / Investigator 6674
Seattle, Washington, United States, 98195
Australia, Victoria
Site Ref # / Investigator 16983
Box Hill, Victoria, Australia, 3128
Austria
Site Ref # / Investigator 16225
Vienna, Austria, 1090
Belgium
Site Ref # / Investigator 16230
Bonheiden, Belgium, 2820
Site Ref # / Investigator 16231
Leuven, Belgium, 3000
Canada, Alberta
Site Ref # / Investigator 9422
Calgary, Alberta, Canada, T2N 4Z6
Site Ref # / Investigator 14042
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
Site Ref # / Investigator 7610
Vancouver, British Columbia, Canada, V6Z-2K5
Canada, Manitoba
Site Ref # / Investigator 8206
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Newfoundland and Labrador
Site Ref # / Investigator 7634
St. John's, Newfoundland and Labrador, Canada, A1B - 3V6
Canada, Nova Scotia
Site Ref # / Investigator 7596
Halifax, Nova Scotia, Canada, B3H 2Y9
Site Ref # / Investigator 7630
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
Site Ref # / Investigator 7641
Hamilton, Ontario, Canada, L8N 3Z5
Site Ref # / Investigator 10681
London, Ontario, Canada, N6A 5K8
Site Ref # / Investigator 17901
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Site Ref # / Investigator 15061
Montreal, Quebec, Canada, H3T 1E2
Site Ref # / Investigator 7629
Montreal, Quebec, Canada, H1T 2M4
Site Ref # / Investigator 14702
Montreal, Quebec, Canada, H3A 1A1
Site Ref # / Investigator 17881
Quebec City, Quebec, Canada, G1R 2J6
Canada, Saskatchewan
Site Ref # / Investigator 14821
Saskatoon, Saskatchewan, Canada, S7N 0W8
Site Ref # / Investigator 7642
Saskatoon, Saskatchewan, Canada, S7K 1N4
Denmark
Site Ref # / Investigator 16985
Herlev, Denmark, DK-2730
Site Ref # / Investigator 16235
Hvivdovre, Denmark, 2650
Site Ref # / Investigator 16234
Odense C, Denmark, 5000
Puerto Rico
Site Ref # / Investigator 10961
Ponce, Puerto Rico, 00717
Site Ref # / Investigator 16801
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
Abbott
Investigators
Study Director: Roberto Carcereri, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00562887     History of Changes
Other Study ID Numbers: M10-222, 2008-004919-36
Study First Received: November 21, 2007
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Abbott:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014