CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 640 enrolled
Drug / intervention
Group 1: Placebo +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/NCT01369342
NCT01369342Phase 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 (UNITI-2)

Janssen Research & Development, LLC·interventional·Posted Jun 8, 2011·Updated Jan 6, 2017

In Brief

A Phase 3 clinical trial evaluating Group 1: Placebo, Group 2 ustekinumab 130 mg, and 1 other intervention for Crohn's Disease and 3 related conditions. Completed, enrolled 640 participants across 220 sites in 22 countries.

Detailed Summary

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.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.1 years ago

Interventions

Group 1: Placebodrug

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

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).