Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00562887
- Lead Sponsor
- Abbott
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 246
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points Week 6
- Secondary Outcome Measures
Name Time Method Patient reported outcomes, clinical response indicators, safety parameters Weeks 12 and 24
Trial Locations
- Locations (61)
Site Ref # / Investigator 6792
🇺🇸Orange, California, United States
Site Ref # / Investigator 6643
🇺🇸San Diego, California, United States
Site Ref # / Investigator 6670
🇺🇸Hamden, Connecticut, United States
Site Ref # / Investigator 6694
🇺🇸Gainesville, Florida, United States
Site Ref # / Investigator 6794
🇺🇸Jacksonville, Florida, United States
Site Ref # / Investigator 6687
🇺🇸Winter Park, Florida, United States
Site Ref # / Investigator 6667
🇺🇸Zephyrhills, Florida, United States
Site Ref # / Investigator 6691
🇺🇸Atlanta, Georgia, United States
Site Ref # / Investigator 6642
🇺🇸Atlanta, Georgia, United States
Site Ref # / Investigator 8797
🇺🇸Macon, Georgia, United States
Scroll for more (51 remaining)Site Ref # / Investigator 6792🇺🇸Orange, California, United States