NCT00562887TerminatedPhase 2
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.
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Abbott
- Enrollment
- 246
- Locations
- 122
- Primary Endpoint
- Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- 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
- •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.
Outcomes
Primary Outcomes
Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points
Time Frame: Week 6
Secondary Outcomes
- Patient reported outcomes, clinical response indicators, safety parameters(Weeks 12 and 24)
Investigators
Study Sites (122)
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