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)

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Pharmaceutical Solutions; Ustekinumab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)