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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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 or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Ustekinumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.