A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
Public ClinicalTrials.gov record NCT01369342. 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 (UNITI-2)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01369342
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 640 participants
Conditions and interventions
Conditions
Interventions
- Group 1: Placebo Drug
- Group 2 ustekinumab 130 mg Drug
- Group 3: ustekinumab approximately 6 mg/kg Drug
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
- Jul 2011 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Oct 2014 (Actual)
- Last update posted
- Jan 6, 2017
2011 – 2014
United States locations
- U.S. sites
- 84
- U.S. states
- 33
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Tucson | Arizona | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | La Jolla | California | — | — |
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| Not listed | Houma | Louisiana | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Chevy Chase | Maryland | — | — |
| Not listed | Columbia | Maryland | — | — |
| Not listed | Towson | Maryland | — | — |
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| Not listed | Worcester | Massachusetts | — | — |
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| Not listed | Chesterfield | Michigan | — | — |
| Not listed | Novi | 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 | Kansas City | Missouri | — | — |
| Not listed | Lees Summit | Missouri | — | — |
| Not listed | Urbana | Missouri | — | — |
| Not listed | Las Vegas | Nevada | — | — |
| Not listed | Egg Harbor | New Jersey | — | — |
| Not listed | Marlton | New Jersey | — | — |
| Not listed | Morristown | New Jersey | — | — |
| Not listed | Great Neck | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Poughkeepsie | 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 | Columbus | Ohio | — | — |
| Not listed | Mentor | Ohio | — | — |
| Not listed | Norman | Oklahoma | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Tulsa | Oklahoma | — | — |
| Not listed | Bend | Oregon | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Malvern | Pennsylvania | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Columbia | South Carolina | — | — |
| Not listed | North Charleston | South Carolina | — | — |
| Not listed | Germantown | Tennessee | — | — |
| 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 | Bellevue | Washington | — | — |
| 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 136 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01369342, 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 Jan 6, 2017 · Synced Oct 25, 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 public registry record, listed eligibility criteria, and available contact information for NCT01369342 live on ClinicalTrials.gov.