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

November 21, 2007
August 18, 2011
November 2007
April 2010   (final data collection date for primary outcome measure)
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points [ Time Frame: Week 6 ]
Complete list of historical versions of study NCT00562887 on ClinicalTrials.gov Archive Site
Patient reported outcomes, clinical response indicators, safety parameters [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Patient reported outcomes, clinical response indicators, safety parameters
Not Provided
Not Provided
 
Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • Biological: Placebo
    every 4 weeks, IV
    Other Name: placebo
  • Biological: ABT-874
    400 mg IV every 4 weeks
    Other Name: ABT-874
  • Biological: ABT-874
    700 mg IV every 4 weeks
    Other Name: ABT-874
  • Placebo Comparator: 1
    Intervention: Biological: Placebo
  • Experimental: 400 mg
    Intervention: Biological: ABT-874
  • Experimental: 700mg
    Intervention: Biological: ABT-874
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
246
Not Provided
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Denmark,   Puerto Rico
 
NCT00562887
M10-222, 2008-004919-36
Yes
Abbott
Abbott
Not Provided
Study Director: Roberto Carcereri, MD Abbott
Abbott
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP