CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,282 enrolled
Drug / intervention
Placebo SC +4 moredrug
Likely dose
Ustekinumab 90 mg SC q8wfrom 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/NCT01369355
NCT01369355Phase 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 Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

Janssen Research & Development, LLC·interventional·Posted Jun 8, 2011·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo SC, Placebo IV, and 3 other interventions for Crohn's Disease and 3 related conditions. Completed, enrolled 1,282 participants across 220 sites in 26 countries.

Detailed Summary

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease, Colitis, IBD, Inflammatory Bowel Disease
CountriesAustralia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Denmark, France, Germany, Hungary, Iceland, Ireland, 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 StartSep 13, 2011
Primary CompletionJun 10, 2015
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 15.1 years ago

Interventions

Placebo SCdrug

Placebo will be administered subcutaneously.

Placebo IVdrug

Placebo will be administered as a single Intravenous infusion at week 0.

Ustekinumab 90 mg SC q8wdrug

Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.

Ustekinumab 130 mg IVdrug

Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.

Ustekinumab 90 mg SC q12wdrug

Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.