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

ClinicalTrials.gov ID: NCT01369355

Public ClinicalTrials.gov record NCT01369355. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 22, 2026, 8:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT01369355
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Janssen Research & Development, LLC; Industry
Enrollment: 1,282 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 99 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 13, 2011 (Actual)
Primary completion: Jun 10, 2015 (Actual)
Completion: Oct 1, 2019 (Actual)
Last update posted: Feb 4, 2025

2011 – 2019

United States locations

U.S. sites: 77
U.S. states: 34
U.S. cities: 77

Facility	City	State	ZIP	Site status
Not listed	Tucson	Arizona	—	—
Not listed	La Jolla	California	—	—
Not listed	Los Angeles	California	—	—
Not listed	San Carlos	California	—	—
Not listed	San Diego	California	—	—
Not listed	Santa Monica	California	—	—
Not listed	Lone Tree	Colorado	—	—
Not listed	New Haven	Connecticut	—	—
Not listed	Boca Raton	Florida	—	—
Not listed	Gainesville	Florida	—	—
Not listed	Jacksonville	Florida	—	—
Not listed	Naples	Florida	—	—
Not listed	Weston	Florida	—	—
Not listed	Winter Park	Florida	—	—
Not listed	Atlanta	Georgia	—	—
Not listed	Decatur	Georgia	—	—
Not listed	Macon	Georgia	—	—
Not listed	Idaho Falls	Idaho	—	—
Not listed	Chicago	Illinois	—	—
Not listed	Evanston	Illinois	—	—
Not listed	Clive	Iowa	—	—
Not listed	Pratt	Kansas	—	—
Not listed	Crestview Hills	Kentucky	—	—
Not listed	Lexington	Kentucky	—	—
Not listed	Louisville	Kentucky	—	—
Not listed	Baton Rouge	Louisiana	—	—
Not listed	New Orleans	Louisiana	—	—
Not listed	Baltimore	Maryland	—	—
Not listed	Chevy Chase	Maryland	—	—
Not listed	Towson	Maryland	—	—
Not listed	Boston	Massachusetts	—	—
Not listed	Worcester	Massachusetts	—	—
Not listed	Ann Arbor	Michigan	—	—
Not listed	Chesterfield	Michigan	—	—
Not listed	Detroit	Michigan	—	—
Not listed	Troy	Michigan	—	—
Not listed	Ypsilanti	Michigan	—	—
Not listed	Rochester	Minnesota	—	—
Not listed	Jackson	Mississippi	—	—
Not listed	Ocean Springs	Mississippi	—	—
Not listed	Columbia	Missouri	—	—
Not listed	Lee's Summit	Missouri	—	—
Not listed	Urbana	Missouri	—	—
Not listed	Las Vegas	Nevada	—	—
Not listed	Lebanon	New Hampshire	—	—
Not listed	Marlton	New Jersey	—	—
Not listed	Great Neck	New York	—	—
Not listed	New York	New York	—	—
Not listed	Poughkeepsie	New York	—	—
Not listed	Rochester	New York	—	—
Not listed	Chapel Hill	North Carolina	—	—
Not listed	Charlotte	North Carolina	—	—
Not listed	Raleigh	North Carolina	—	—
Not listed	Cincinnati	Ohio	—	—
Not listed	Cleveland	Ohio	—	—
Not listed	Columbus	Ohio	—	—
Not listed	Mentor	Ohio	—	—
Not listed	Oklahoma City	Oklahoma	—	—
Not listed	Bend	Oregon	—	—
Not listed	Portland	Oregon	—	—
Not listed	Hershey	Pennsylvania	—	—
Not listed	Philadelphia	Pennsylvania	—	—
Not listed	Pittsburgh	Pennsylvania	—	—
Not listed	Charleston	South Carolina	—	—
Not listed	Columbia	South Carolina	—	—
Not listed	North Charleston	South Carolina	—	—
Not listed	Nashville	Tennessee	—	—
Not listed	Austin	Texas	—	—
Not listed	Grapevine	Texas	—	—
Not listed	Houston	Texas	—	—
Not listed	Tyler	Texas	—	—
Not listed	Salt Lake City	Utah	—	—
Not listed	Charlottesville	Virginia	—	—
Not listed	Chesapeake	Virginia	—	—
Not listed	Virginia Beach	Virginia	—	—
Not listed	Seattle	Washington	—	—
Not listed	Madison	Wisconsin	—	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 143 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01369355, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 4, 2025 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01369355 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →