Status:
COMPLETED
A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
Lead Sponsor:
Centocor, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe...
Detailed Description
In Crohn's disease there is inflammation (changes in body tissue which normally happen during injury or infection) and or ulceration (open sores) in the intestines.This occurs because the immune syste...
Eligibility Criteria
Inclusion
- Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration
- Must have received Remicade, adalimumab or Cimzia at a dose approved for the treatment of Crohn's disease
- Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of Crohn's disease
- Must be 18 years of age or older
- Must have active Crohn's disease according to the Crohn's Disease Activity Index (CDAI \> =220 and \< =450).
Exclusion
- Patients who have had any kind of bowel resection, diversions or placement of a stoma within 6 months
- Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study or within 1 year after receiving study agent
- Patients who have received Remicade, Humira or Cimzia \< =8 weeks before the first administration of study drug
- Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
- Patients with a history of or ongoing chronic or recurrent infectious disease.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT00771667
Start Date
December 1 2008
End Date
December 1 2010
Last Update
April 1 2013
Active Locations (174)
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1
Mobile, Alabama, United States
2
Scottsdale, Arizona, United States
3
La Jolla, California, United States
4
Los Angeles, California, United States