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
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
2 other identifiers
interventional
526
11 countries
160
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2008
160 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
July 27, 2012
CompletedApril 1, 2013
March 1, 2013
1.4 years
October 10, 2008
October 10, 2011
March 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinical Response at Week 6
As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.
Baseline to Week 6
Secondary Outcomes (6)
Number of Participants With Clinical Remission at Week 6
Baseline to Week 6
Number of Participants With Clinical Response at Week 4
Baseline to Week 4
Number of Participants With Clinical Response at Week 8
Baseline to Week 8
Number of Participants With Clinical Remission at Week 8
Baseline to Week 8
Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)
Baseline to Week 22
- +1 more secondary outcomes
Study Arms (10)
Placebo (IP)
PLACEBO COMPARATORUstekinumab 1mg/kg (IP)
EXPERIMENTALUstekinumab 3 mg/kg (IP)
EXPERIMENTALUstekinumab 6 mg/kg (IP)
EXPERIMENTALPlacebo IV - Responder - Placebo SC (MP)
PLACEBO COMPARATORPlacebo IV - Nonresponder - Ustekinumab 270/90 mg SC
PLACEBO COMPARATORUstekinumab IV - Responder - Placebo SC (MP)
PLACEBO COMPARATORUstekinumab IV - Responder - Ustekinumab 90mg SC (MP)
EXPERIMENTALUstekinumab IV - Nonresponder - Placebo SC (MP)
PLACEBO COMPARATORUstekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)
EXPERIMENTALInterventions
Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group
Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16
Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16
Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Placebo SC at Week 8 and Week 16
Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
Eligibility Criteria
You may qualify if:
- Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration
- Must have received Remicade, adalimumab or Cimzia at a dose approved for the treatment of Crohn's disease
- Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of Crohn's disease
- Must be 18 years of age or older
- Must have active Crohn's disease according to the Crohn's Disease Activity Index (CDAI \> =220 and \< =450).
You may not qualify if:
- Patients who have had any kind of bowel resection, diversions or placement of a stoma within 6 months
- Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study or within 1 year after receiving study agent
- Patients who have received Remicade, Humira or Cimzia \< =8 weeks before the first administration of study drug
- Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
- Patients with a history of or ongoing chronic or recurrent infectious disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (174)
Unknown Facility
Mobile, Alabama, United States
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Scottsdale, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Roseville, California, United States
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San Carlos, California, United States
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San Francisco, California, United States
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Englewood, Colorado, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Hamden, Connecticut, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Port Charlotte, Florida, United States
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Port Orange, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Winter Park, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Decatur, Georgia, United States
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Macon, Georgia, United States
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Newnan, Georgia, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Indianapolis, Indiana, United States
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Clive, Iowa, United States
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Pratt, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, 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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Burlington, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Chesterfield, Michigan, United States
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Detroit, Michigan, United States
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Troy, Michigan, United States
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Rochester, Minnesota, United States
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Ocean Springs, Mississippi, United States
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Mexico, Missouri, United States
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Lebanon, New Hampshire, United States
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Egg Harbor, 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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Poughkeepsie, New York, United States
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Setauket, New York, United States
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Stony Brook, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Kinston, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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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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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Lewisville, Texas, United States
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San Antonio, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Bellevue, Washington, United States
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Lakewood, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Adelaide, Australia
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Bankstown, Australia
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Bedford Park, Australia
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Box Hill, Australia
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Concord, Australia
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East Melbourne, Australia
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Fitzroy, Australia
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Frankston, Australia
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Fremantle, Australia
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Garran, Australia
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Herston, Australia
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Parkville, Australia
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Prahran, Australia
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South Brisbane, Australia
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Innsbruck, Austria
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Linz, Austria
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Salzburg, Austria
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Vienna, Austria
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Bonheiden, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Amiens Cedex 1 80, France
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Grenoble, France
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Lille, France
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Nice, France
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Paris, France
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Pessac, France
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Rouen, France
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Toulouse Cedex 9 N/A, France
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Berlin, Germany
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Hamburg, Germany
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Hanover, Germany
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Kiel, Germany
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Leipzig, Germany
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Lÿneburg, Germany
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Markkleeberg, Germany
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Minden, Germany
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München, Germany
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Münster, Germany
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Regensburg, Germany
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Afula, Israel
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Beersheba, Israel
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Haifa, 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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Tel Aviv, Israel
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Amersfoort, Netherlands
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Amsterdam, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Barcelona, Spain
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Córdoba, Spain
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León, Spain
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Madrid, Spain
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Oviedo, Spain
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Palma, Spain
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Sabadell, Spain
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Zaragoza, Spain
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Bristol, United Kingdom
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Cambridge, United Kingdom
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Coventry, United Kingdom
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Edinburgh, United Kingdom
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Harrow, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Norwich, United Kingdom
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Nottinghamshirecc, United Kingdom
Related Publications (4)
Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.
PMID: 36150926DERIVEDGhosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
PMID: 30739254DERIVEDDi Narzo AF, Telesco SE, Brodmerkel C, Argmann C, Peters LA, Li K, Kidd B, Dudley J, Cho J, Schadt EE, Kasarskis A, Dobrin R, Hao K. High-Throughput Characterization of Blood Serum Proteomics of IBD Patients with Respect to Aging and Genetic Factors. PLoS Genet. 2017 Jan 27;13(1):e1006565. doi: 10.1371/journal.pgen.1006565. eCollection 2017 Jan.
PMID: 28129359DERIVEDSandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, Sands BE, Hanauer SB, Targan S, Rutgeerts P, Ghosh S, de Villiers WJ, Panaccione R, Greenberg G, Schreiber S, Lichtiger S, Feagan BG; CERTIFI Study Group. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012 Oct 18;367(16):1519-28. doi: 10.1056/NEJMoa1203572.
PMID: 23075178DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Janssen Research and Development, US
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 13, 2008
Study Start
December 1, 2008
Primary Completion
May 1, 2010
Study Completion
December 1, 2010
Last Updated
April 1, 2013
Results First Posted
July 27, 2012
Record last verified: 2013-03