A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
Public ClinicalTrials.gov record NCT00771667. 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 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.
Study identification
- NCT ID
- NCT00771667
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 526 participants
Conditions and interventions
Conditions
Interventions
- Placebo (IP) Drug
- Ustekinumab 1mg/kg (IP) Drug
- Ustekinumab 3 mg/kg (IP) Drug
- Ustekinumab 6 mg/kg (IP) Drug
- Placebo IV - Responder - Placebo SC (MP) Drug
- Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP) Drug
- Ustekinumab IV - Responder - Placebo SC (MP) Drug
- Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP) Drug
- Ustekinumab IV - Nonresponder - Placebo SC (MP) Drug
- Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP) 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
- Dec 2008 (Type not available)
- Primary completion
- May 2010 (Actual)
- Completion
- Dec 2010 (Actual)
- Last update posted
- Apr 1, 2013
2008 – 2010
United States locations
- U.S. sites
- 88
- U.S. states
- 33
- U.S. cities
- 88
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mobile | Alabama | — | — |
| Not listed | Scottsdale | Arizona | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Roseville | California | — | — |
| Not listed | San Carlos | California | — | — |
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| Not listed | Englewood | Colorado | — | — |
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| Not listed | Littleton | Colorado | — | — |
| Not listed | Hamden | Connecticut | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Hollywood | Florida | — | — |
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| Not listed | South Miami | Florida | — | — |
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| Not listed | Vero Beach | Florida | — | — |
| Not listed | Winter Park | Florida | — | — |
| Not listed | Zephyrhills | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Columbus | Georgia | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Macon | Georgia | — | — |
| Not listed | Newnan | Georgia | — | — |
| Not listed | Arlington Heights | Illinois | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Evanston | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Clive | Iowa | — | — |
| Not listed | Pratt | Kansas | — | — |
| Not listed | Lexington | Kentucky | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Chevy Chase | Maryland | — | — |
| Not listed | Towson | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Burlington | Massachusetts | — | — |
| Not listed | Worcester | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Chesterfield | Michigan | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | Troy | Michigan | — | — |
| Not listed | Rochester | Minnesota | — | — |
| Not listed | Ocean Springs | Mississippi | — | — |
| Not listed | Mexico | Missouri | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | Egg Harbor | New Jersey | — | — |
| Not listed | Great Neck | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Poughkeepsie | New York | — | — |
| Not listed | Setauket | New York | — | — |
| Not listed | Stony Brook | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Greenville | North Carolina | — | — |
| Not listed | Kinston | North Carolina | — | — |
| Not listed | New Bern | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Not listed | Beavercreek | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Dayton | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Columbia | South Carolina | — | — |
| Not listed | Chattanooga | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Lewisville | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Ogden | Utah | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Burlington | Vermont | — | — |
| Not listed | Charlottesville | Virginia | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Bellevue | Washington | — | — |
| Not listed | Lakewood | Washington | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Tacoma | 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 86 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00771667, 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 Apr 1, 2013 · Synced Oct 17, 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 NCT00771667 live on ClinicalTrials.gov.