A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

Completed · Phase 3 · Has a placebo group

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

In brief

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

Key facts

Study ID

NCT01369342

Run by

Janssen Research & Development, LLC

People needed

640

Starts

2011-07-01

Expected to finish

2014-10-01

Last updated by the study team

2017-01-06

Who can join

Age: 18 and older, up to 99. 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 Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
• Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
• 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 — San Diego, California, United States
• Study site — Santa Monica, California, United States
• Study site — Torrance, California, United States
• Study site — Lone Tree, Colorado, United States
• Study site — Boca Raton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Athens, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Clive, Iowa, United States
• Study site — Pratt, Kansas, United States
• Study site — Topeka, Kansas, United States
• Study site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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