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

  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 August 28, 2014