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

  Show 61 Study Locations
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 April 17, 2014