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

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ClinicalTrials.gov Identifier: NCT00562887
Recruitment Status : Terminated
First Posted : November 26, 2007
Last Update Posted : August 23, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott

Tracking Information
First Submitted Date  ICMJE November 21, 2007
First Posted Date  ICMJE November 26, 2007
Last Update Posted Date August 23, 2011
Study Start Date  ICMJE November 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points [ Time Frame: Week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00562887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
Patient reported outcomes, clinical response indicators, safety parameters [ Time Frame: Weeks 12 and 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2007)
Patient reported outcomes, clinical response indicators, safety parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Biological: Placebo
    every 4 weeks, IV
  • Biological: ABT-874
    400 mg IV every 4 weeks
  • Biological: ABT-874
    700 mg IV every 4 weeks
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Biological: Placebo
  • Experimental: 400 mg
    Intervention: Biological: ABT-874
  • Experimental: 700mg
    Intervention: Biological: ABT-874
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 2, 2009)
246
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2007)
420
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Denmark,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00562887
Other Study ID Numbers  ICMJE M10-222
2008-004919-36 ( Registry Identifier: EudraCT )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Roberto Carcereri, MD Abbott
PRS Account Abbott
Verification Date August 2011

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