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)
Public ClinicalTrials.gov record NCT01369329. 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.
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 Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
Study identification
- NCT ID
- NCT01369329
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Janssen Research & Development, LLC
- Industry
- Enrollment
- 769 participants
Conditions and interventions
Conditions
Interventions
- Group 2 ustekinumab 130 mg Drug
- Group 3: ustekinumab approximately 6 mg/kg Drug
- Group 1: Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jun 30, 2011
- Primary completion
- May 31, 2013
- Completion
- Jun 30, 2013
- Last update posted
- Dec 6, 2016
2011 – 2013
United States locations
- U.S. sites
- 67
- U.S. states
- 33
- U.S. cities
- 67
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Tucson | Arizona | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Redwood City | California | — | — |
| Not listed | San Carlos | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Lone Tree | Colorado | — | — |
| Not listed | New Haven | Connecticut | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Weston | Florida | — | — |
| Not listed | Winter Park | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Macon | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Evanston | Illinois | — | — |
| Not listed | Clive | Iowa | — | — |
| 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 | Novi | Michigan | — | — |
| Not listed | Troy | Michigan | — | — |
| Not listed | Rochester | Minnesota | — | — |
| Not listed | Ocean Springs | Mississippi | — | — |
| Not listed | Lees Summit | Missouri | — | — |
| Not listed | Urbana | Missouri | — | — |
| Not listed | Las Vegas | Nevada | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | Marlton | New Jersey | — | — |
| Not listed | Morristown | New Jersey | — | — |
| Not listed | Great Neck | New York | — | — |
| Not listed | New York | 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 | Beavercreek | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Bend | Oregon | — | — |
| Not listed | Springfield | Oregon | — | — |
| Not listed | Hershey | Pennsylvania | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | North Charleston | South Carolina | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Austin | 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 | Norfolk | 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 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01369329, 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 Dec 6, 2016 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01369329 live on ClinicalTrials.gov.