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

Completed · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00771667

Run by

Centocor, Inc.

People needed

526

Starts

2008-12-01

Expected to finish

2010-12-01

Last updated by the study team

2013-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Roseville, California, United States
• Study site — San Carlos, California, United States
• Study site — San Francisco, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Hamden, Connecticut, United States
• Study site — Gainesville, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Panama City, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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