A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease, IBD, Colitis, Inflammatory Bowel Disease

In brief

This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).

Key facts

Study ID

NCT01369329

Run by

Janssen Research & Development, LLC

People needed

769

Starts

2011-07-01

Expected to finish

2013-07-01

Last updated by the study team

2016-12-07

Who can join

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

You may qualify if…

• Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
• Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450
• Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn disease and did not respond initially (ie, primary nonresponse)
• Or responded initially but then lost response with continued therapy (ie, secondary nonresponse)
• Or were intolerant to the medication
• Have screening laboratory test results within protocol-specified parameters.

You may not qualify if…

• Patients who have had any kind of bowel resection within 6 months
• Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
• Patients who have received infliximab, adalimumab or certolizumab pegol < = 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
• Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Redwood City, California, United States
• Study site — San Carlos, California, United States
• Study site — San Diego, California, United States
• Study site — Lone Tree, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Weston, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Evanston, Illinois, United States
• Study site — Clive, Iowa, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Chevy Chase, Maryland, United States
• Study site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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