CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 769 enrolled
Drug / intervention
Group 2 ustekinumab 130 mg +2 moredrug
Likely dose
Group 2 ustekinumab 130 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01369329
NCT01369329Phase 3Completed
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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

Janssen Research & Development, LLC·interventional·Posted Jun 8, 2011·Updated Dec 7, 2016

In Brief

A Phase 3 clinical trial evaluating Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg, and 1 other intervention for Crohn's Disease and 3 related conditions. Completed, enrolled 769 participants across 175 sites in 23 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease, IBD, Colitis, Inflammatory Bowel Disease
CountriesAustralia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Iceland, Ireland, Israel, Japan, Netherlands, New Zealand, Poland, Serbia, South Africa, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2011
Enrollment StartJul 1, 2011
Primary CompletionJun 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.1 years ago

Interventions

Group 2 ustekinumab 130 mgdrug

Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.

Group 3: ustekinumab approximately 6 mg/kgdrug

Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg), 390 mg (weight \> 55 kg and \<= 85 kg), and 520 mg (weight \> 85 kg).

Group 1: Placebodrug

Form=solution for injection, route=intravenous use, in a single dose.