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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01369355
First received: June 7, 2011
Last updated: June 10, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Colitis
IBD
Inflammatory Bowel Disease
Drug: Placebo
Drug: Ustekinumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Clinical remission [ Time Frame: at Week 44 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission in patient subgroups such as those in remission at Week 0 or those who previously failed TNF-antagonists (ie, patients entering from study CNTO1275CRD3001) [ Time Frame: at Week 44 ] [ Designated as safety issue: No ]
  • Clinical response [ Time Frame: at Week 44 ] [ Designated as safety issue: No ]
  • Corticosteroid-free remission [ Time Frame: at Week 44 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1310
Study Start Date: September 2011
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 001

Placebo Responders to ustekinumab:

Form=solution for injection route=Subcutaneous use. One SC injection q4w

Drug: Placebo

Responders to ustekinumab:

Form=solution for injection, route=Subcutaneous use. One SC injection q4w

Experimental: 002

Ustekinumab Responders to ustekinumab:

Form=solution for injection route=Subcutaneous use. One SC injection q12w

Drug: Ustekinumab

Responders to ustekinumab:

Form=solution for injection, route=Subcutaneous use. One SC injection q12w

Experimental: 003
Ustekinumab Responders to ustekinumab: type=1 unit=mg number=90 form=solution for injection route=Subcutaneous use. One SC injection q8w
Drug: Ustekinumab
Responders to ustekinumab: type=1, unit=mg, number=90, form=solution for injection, route=Subcutaneous use. One SC injection q8w
Experimental: 004
Ustekinumab Nonresponders to IV induction ustekinumab: type=1 unit=mg number=90 form=solution for injection route=Subcutaneous use. One SC injection at Week 0 if then respond one SC injection q8w
Drug: Ustekinumab
Nonresponders to IV induction ustekinumab: type=1, unit=mg, number=90, form=solution for injection, route=Subcutaneous use. One SC injection at Week 0
Experimental: 005
Ustekinumab Nonresponders to IV placebo: type=1 unit=mg number=130 form=solution for injection route=Intravenous use. One IV administration at Week 0 if then respond one SC injection ustekinumab 90 mg at Week 8 and then q12w
Drug: Ustekinumab
if then respond, one SC injection q8w

Detailed Description:

The main purpose of this study is to determine whether additional ustekinumab treatment is beneficial in patients with moderately to severely active Crohn's disease who initially had a clinical response to IV ustekinumab in one of the 2 initial induction studies (the CNTO1275CRD3001 ["UNITI-1"] or CNTO1275CRD3002 ["UNITI-2"] induction studies). The maintenance treatment will be injections in the skin (given subcutaneously, or "SC") of 90 mg ustekinumab either every 8 weeks or 12 weeks, and the effects (both the benefits and any side effects or adverse events) will be compared to SC placebo injections (otherwise identical except without ustekinumab). Patients who responded to IV ustekinumab in the UNITI-1 or UNITI-2 induction studies will be put into one of these 3 groups by chance (randomly, like rolling dice). The study will be double-blinded (so that neither patients nor study personnel know the identity of the assigned treatment). Patients who are randomized to either SC placebo or 90mg ustekinumab SC every 12 weeks who experience worsening in their Crohn's Disease symptoms (per the study loss of response criteria) will have their treatment adjusted so that they will instead start to receive 90mg ustekinumab SC every 8 weeks. All patients from the UNITI-1 or UNITI-2 studies (in addition to the patients described above who responded to IV ustekinumab) will be eligible to enter this study, provided the Week 8 visit in those trials was completed and study requirements are still met. Patients who are not in clinical response to IV placebo or ustekinumab in UNITI-1 or UNITI-2 will receive both IV and SC study agent at the first visit of this study (week 0). Patients previously receiving IV placebo will receive ustekinumab 130 mg IV at week 0 (and SC placebo), and patients previously receiving IV ustekinumab will receive 90 mg ustekinumab SC at week 0 (as well as IV placebo). If these patients are in clinical response 8 weeks later, they will receive 90 SC ustekinumab at that week8 visit, and will continue to receive ustekinumab throughout the rest of the study (provided they otherwise remain eligible). Patients in clinical response to IV placebo induction dosing will continue to receive SC placebo. The main part of this study, also called the maintenance portion, will last 44 weeks. After week 44, all patients who are continuing to do well will be eligible to continue to receive study agent in the second part of the study, a long term extension where the study agent will continue to be administered for (up to) 3 additional years. Patients who discontinue study agent, either during the study, or after the full 4 years, will be asked to return for a final safety follow-up visit 20 weeks after they last received study agent.

Patients in response to IV ustekinumab will be randomized to receive either placebo (Group 1), Ustekinumab 90 mg SC every 12 weeks (Group 2), or Ustekinumab 90mgSC every 8 weeks (Group 3). If patients in Groups 1 or 2 lose response, they will cross over to receive ustekinumab 90mg every 8 weeks. Other populations (nonresponders to prior IV ustekinumab or IV placebo) will receive ustekinumab at Week0 (either 90mg SC or 130mg IV, respectively) and continue SC ustekinumab if in response at Week8

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who received study agent at the start of study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:
  • Patients who underwent a Crohn's disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002
  • Patients who started a protocol prohibited medication since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002
  • Patients with protocol-specified changes to their concomitant medications due to Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369355

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, Alabama
Withdrawn
Birmingham, Alabama, United States
United States, Arizona
Active, not recruiting
Tucson, Arizona, United States
United States, Arkansas
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Little Rock, Arkansas, United States
United States, California
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La Jolla, California, United States
Active, not recruiting
La Jolla, California, United States
Active, not recruiting
Los Angeles, California, United States
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Orange, California, United States
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Redwood City, California, United States
Completed
San Carlos, California, United States
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San Diego, California, United States
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San Francisco, California, United States
Active, not recruiting
Santa Monica, California, United States
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Torrance, California, United States
United States, Colorado
Active, not recruiting
Lone Tree, Colorado, United States
United States, Connecticut
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New Haven, Connecticut, United States
United States, Florida
Active, not recruiting
Boca Raton, Florida, United States
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Gainesville, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Port Orange, Florida, United States
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Weston, Florida, United States
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Winter Park, Florida, United States
United States, Georgia
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Macon, Georgia, United States
United States, Idaho
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Idaho Falls, Idaho, United States
United States, Illinois
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
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Clive, Iowa, United States
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Iowa City, Iowa, United States
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Pratt, Kansas, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Chevy Chase, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
United States, Michigan
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Ann Arbor, Michigan, United States
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United States, Mississippi
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Jackson, Mississippi, United States
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Ocean Springs, Mississippi, United States
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Columbia, Missouri, United States
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Lebanon, New Hampshire, United States
United States, New Jersey
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Marlton, New Jersey, United States
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Great Neck, New York, United States
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New York, New York, United States
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New York, New York, United States
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Rochester, New York, United States
United States, North Carolina
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
United States, Ohio
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Beavercreek, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
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Eugene, Oregon, United States
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United States, Pennsylvania
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Hershey, Pennsylvania, United States
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Malvern, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
United States, South Carolina
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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North Charleston, South Carolina, United States
United States, Tennessee
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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United States, Virginia
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Charlottesville, Virginia, United States
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Chesapeake, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
Recruiting
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United States, Washington
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Bellevue, Washington, United States
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Seattle, Washington, United States
United States, Wisconsin
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Madison, Wisconsin, United States
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Madison, Wisconsin, United States
Australia
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Adelaide, Australia
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Bedford Park, Australia
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Box Hill, Australia
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Brisbane, Australia
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Cairns, Australia
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Central Queensland M C, Australia
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Concord, Australia
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Fremantle, Australia
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Garran, Australia
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Liverpool, Australia
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Malvern, Australia
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Parkville, Australia
Austria
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Innsbruck, Austria
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St Poelten, Austria
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Wien, Austria
Belgium
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Brussel, Belgium
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Gent, Belgium
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Leuven, Belgium
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Liege, Belgium
Brazil
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Goiânia, Brazil
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Porto Alegre, Brazil
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Rio De Janeiro, Brazil
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Sao Paulo, Brazil
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Sao Paulo, Brasil, Brazil
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São Paulo, Brazil
Bulgaria
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Rousse, Bulgaria
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Canada, Alberta
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Canada, Saskatchewan
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Canada
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Saskatoon N/A, Canada
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Toronto, Canada
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Winnipeg, Canada
Croatia
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Avenija Gojka Suska 6, Croatia
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Osijek, Croatia
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Rijeka, Croatia
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Zagreb, Croatia
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Zagreb, Croatia
Czech Republic
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Brno, Czech Republic
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Hradec Kralove, Czech Republic
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Olomouc, Czech Republic
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Usti Nad Labem, Czech Republic
Denmark
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Aalborg, Denmark
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Aarhus C., Denmark
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Herlev, Denmark
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Silkeborg, Denmark
France
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Caen Cedex 9, France
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Grenoble, France
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Lille, France
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Marseille, France
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Nantes, France
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Nice, France
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Paris, France
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Paris Cedex 18, France
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Pessac, France
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Reims, France
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Rennes, France
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Rouen, France
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Toulouse, France
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Vandoeuvre Les Nancy, France
Germany
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Berlin, Germany
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Bochum, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg, Germany
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Halle, Germany
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Hamburg, Germany
Active, not recruiting
Hamburg, Germany
Active, not recruiting
Hannover, Germany
Active, not recruiting
Haßloch, Germany
Active, not recruiting
Heidelberg, Germany
Active, not recruiting
Jena, Germany
Recruiting
Kiel, Germany
Active, not recruiting
Lÿneburg, Germany
Active, not recruiting
Mannheim, Germany
Withdrawn
Minden, Germany
Active, not recruiting
München, Germany
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Münster, Germany
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Oberhausen, Germany
Active, not recruiting
Regensburg, Germany
Active, not recruiting
Stade, Germany
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Tübingen, Germany
Active, not recruiting
Ulm, Germany
Hungary
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Budapest, Hungary
Active, not recruiting
Budapest, Hungary
Active, not recruiting
Budapest N/A, Hungary
Active, not recruiting
Békéscsaba, Hungary
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Debrecen, Hungary
Withdrawn
Gyula, Hungary
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Miskolc, Hungary
Active, not recruiting
Mosonmagyarovar, Hungary
Active, not recruiting
Pecs, Hungary
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Szekesfehervar, Hungary
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Szeksz Rd N/A, Hungary
Iceland
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Akureyri, Iceland
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Reykjavik, Iceland
Ireland
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Dublin, Ireland
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Dublin 8, Ireland
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Dublin 9, Ireland
Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Petah Tikva, Israel
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Ramat-Gan, Israel
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Rehovot, Israel
Active, not recruiting
Tel Aviv, Israel
Recruiting
Zerifin, Israel
Japan
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Bunkyo, Japan
Active, not recruiting
Chikushino, Japan
Active, not recruiting
Fukuoka, Japan
Recruiting
Hachioji, Japan
Active, not recruiting
Hamamatsu, Japan
Recruiting
Hirosaki, Japan
Recruiting
Hiroshima, Japan
Active, not recruiting
Kagoshima, Japan
Withdrawn
Nakagami Gun, Japan
Active, not recruiting
Nishinomiya, Japan
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Ohtsu, Japan
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Oita, Japan
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Osaka, Japan
Active, not recruiting
Sakura, Japan
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Sapporo, Japan
Active, not recruiting
Sendai, Japan
Active, not recruiting
Suita-Shi, Japan
Recruiting
Tokyo, Japan
Active, not recruiting
Tokyo, Japan
Recruiting
Tsu, Japan
Recruiting
Uruma, Japan
Active, not recruiting
Yokkaichi, Japan
Active, not recruiting
Yokohama, Japan
Recruiting
Yokosuka, Japan
Korea, Republic of
Active, not recruiting
Daegu, Korea, Republic of
Active, not recruiting
Gyeonggi-Do, Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of
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Seoul, Korea, Republic of
Netherlands
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Amsterdam, Netherlands
Active, not recruiting
Amsterdam, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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Rotterdam, Netherlands
New Zealand
Active, not recruiting
Auckland, New Zealand
Active, not recruiting
Christchurch, New Zealand
Active, not recruiting
Dunedin, New Zealand
Active, not recruiting
Grafton, New Zealand
Active, not recruiting
Hamilton, New Zealand
Active, not recruiting
Hastings, New Zealand
Active, not recruiting
Plenty, New Zealand
Withdrawn
Wellington, New Zealand
Poland
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Bydgoszcz, Poland
Active, not recruiting
Elblag, Poland
Active, not recruiting
Krakow, Poland
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Krakow, Poland
Active, not recruiting
Lodz, Poland
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Poznan, Poland
Active, not recruiting
Warszawa, Poland
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Wroclaw, Poland
Russian Federation
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Kaluga, Russian Federation
Active, not recruiting
Moscow, Russian Federation
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Nizhny Novgorod, Russian Federation
Active, not recruiting
Novosibirsk, Russian Federation
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Saint Petersburg, Russian Federation
Active, not recruiting
Saint-Petersburg, Russian Federation
Serbia
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Belgrade, Serbia
Active, not recruiting
Belgrade, Serbia
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Nis, Serbia
South Africa
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Benoni, South Africa
Active, not recruiting
Cape Town, South Africa
Active, not recruiting
Cape Town Western Cape, South Africa
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Capetown, South Africa
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Durban, South Africa
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Joannesburg, South Africa
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Johannesburg N/A, South Africa
Active, not recruiting
Pretoria, South Africa
Active, not recruiting
Somerset West Western Cape, South Africa
Spain
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Barcelona, Spain
Active, not recruiting
Madrid, Spain
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Sagunto, Spain
Withdrawn
Santiago De Compostela, Spain
United Kingdom
Active, not recruiting
Birmingham, United Kingdom
Active, not recruiting
Brighton, United Kingdom
Active, not recruiting
Bristol, United Kingdom
Active, not recruiting
Cambridge, United Kingdom
Active, not recruiting
Cardiff, United Kingdom
Active, not recruiting
Exeter, United Kingdom
Active, not recruiting
Gloucester, United Kingdom
Withdrawn
Harrow, United Kingdom
Active, not recruiting
Liverpool, United Kingdom
Active, not recruiting
London, United Kingdom
Withdrawn
London, United Kingdom
Active, not recruiting
Manchester, United Kingdom
Active, not recruiting
Norwich, United Kingdom
Active, not recruiting
Nottinghamshirecc, United Kingdom
Active, not recruiting
Oxford, United Kingdom
Active, not recruiting
Shropshire, United Kingdom
Withdrawn
Somerset, United Kingdom
Withdrawn
South Shields, United Kingdom
Active, not recruiting
Southampton, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01369355     History of Changes
Other Study ID Numbers: CR018421, CNTO1275CRD3003, 2010-022760-12
Study First Received: June 7, 2011
Last Updated: June 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Ustekinumab
Stelara, Moderately to severely active Crohn's Disease
IBD, Crohn's
UNITI
colitis
IL-12
IL-23

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 01, 2015