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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00771667

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.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 5:49 PM 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 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

Study identification

NCT ID
NCT00771667
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Centocor, Inc.
Industry
Enrollment
526 participants

Conditions and interventions

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
Nov 30, 2008
Primary completion
Apr 30, 2010
Completion
Nov 30, 2010
Last update posted
Mar 31, 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
Not listed San Francisco California
Not listed Englewood Colorado
Not listed Lakewood Colorado
Not listed Littleton Colorado
Not listed Hamden Connecticut
Not listed Gainesville Florida
Not listed Hollywood Florida
Not listed Jacksonville Florida
Not listed Miami Florida
Not listed Naples Florida
Not listed Panama City Florida
Not listed Pembroke Pines Florida
Not listed Port Charlotte Florida
Not listed Port Orange Florida
Not listed South Miami Florida
Not listed Tampa Florida
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 Mar 31, 2013 · Synced Jun 26, 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 NCT00771667 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →