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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.

Key facts

Study ID

NCT00562887

Run by

Abbott

People needed

246

Starts

2007-11-01

Last updated by the study team

2011-08-23

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Site Ref # / Investigator 6925 — Baton Rouge, Louisiana, United States
• Site Ref # / Investigator 6865 — Chevy Chase, Maryland, United States
• Site Ref # / Investigator 10202 — Towson, Maryland, United States
• Site Ref # / Investigator 6866 — Rochester, Minnesota, United States
• Site Ref # / Investigator 6778 — Mexico, Missouri, United States
• Site Ref # / Investigator 7048 — St Louis, Missouri, United States
• Site Ref # / Investigator 7952 — Las Vegas, Nevada, United States
• Site Ref # / Investigator 6647 — Cedar Knolls, New Jersey, United States
• Site Ref # / Investigator 6689 — Great Neck, New York, United States
• Site Ref # / Investigator 6652 — Lake Success, New York, United States
• Site Ref # / Investigator 7047 — New York, New York, United States
• Site Ref # / Investigator 6693 — Asheville, North Carolina, United States
• Site Ref # / Investigator 6785 — Charlotte, North Carolina, United States
• Site Ref # / Investigator 9070 — Morgantown, North Carolina, United States
• Site Ref # / Investigator 6651 — Raleigh, North Carolina, United States
• Site Ref # / Investigator 6792 — Orange, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.