COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562887
Recruitment Status : Terminated
First Posted : November 26, 2007
Last Update Posted : August 23, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: Placebo Biological: ABT-874 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : November 2007
Actual Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Placebo Comparator: 1 Biological: Placebo
every 4 weeks, IV

Experimental: 400 mg Biological: ABT-874
400 mg IV every 4 weeks

Experimental: 700mg Biological: ABT-874
700 mg IV every 4 weeks

Primary Outcome Measures :
  1. Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Patient reported outcomes, clinical response indicators, safety parameters [ Time Frame: Weeks 12 and 24 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562887

Show Show 61 study locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: Roberto Carcereri, MD Abbott
Layout table for additonal information
Responsible Party: Abbott Identifier: NCT00562887    
Other Study ID Numbers: M10-222
2008-004919-36 ( Registry Identifier: EudraCT )
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011
Keywords provided by Abbott:
Crohn's Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs