A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
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 Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
3 other identifiers
interventional
769
22 countries
172
Brief Summary
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
172 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
December 7, 2016
CompletedDecember 7, 2016
October 1, 2016
1.9 years
June 7, 2011
August 1, 2016
October 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinical Response at Week 6
Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Baseline and Week 6
Secondary Outcomes (4)
Number of Participants in Clinical Remission at Week 8
Baseline and Week 8
Number of Participants in Clinical Response at Week 8
Baseline and Week 8
Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6
Baseline and Week 6
Number of Participants With CDAI 70-point Response at Week 3
Baseline and Week 3
Study Arms (3)
001
PLACEBO COMPARATORGroup 1: Placebo Form=solution for injection route=intravenous use in a single dose.
002
EXPERIMENTALGroup 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
003
EXPERIMENTALGroup 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg) 390 mg (weight \> 55 kg and \<= 85 kg) and 520 mg (weight \> 85 kg).
Interventions
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg), 390 mg (weight \> 55 kg and \<= 85 kg), and 520 mg (weight \> 85 kg).
Eligibility Criteria
You may qualify if:
- Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
- Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of \>= 220 and \<= 450
- Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn disease and did not respond initially (ie, primary nonresponse)
- Or responded initially but then lost response with continued therapy (ie, secondary nonresponse)
- Or were intolerant to the medication
- Have screening laboratory test results within protocol-specified parameters.
You may not qualify if:
- Patients who have had any kind of bowel resection within 6 months
- Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
- Patients who have received infliximab, adalimumab or certolizumab pegol \< = 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
- Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (175)
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Redwood City, California, United States
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San Carlos, California, United States
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San Diego, California, United States
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Lone Tree, Colorado, United States
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New Haven, Connecticut, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Weston, Florida, United States
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Winter Park, Florida, 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
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Clive, Iowa, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, 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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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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Novi, 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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Lees Summit, Missouri, United States
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Urbana, Missouri, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Marlton, New Jersey, United States
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Morristown, 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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Rochester, 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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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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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
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Springfield, Oregon, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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North Charleston, South Carolina, 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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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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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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Virginia Beach, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Bedford Park, Australia
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Box Hill, Australia
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Central Queensland M C, Australia
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Concord, 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
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Innsbruck, Austria
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Sankt Pölten, Austria
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Vienna, Austria
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Rio de Janeiro, Brazil
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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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Brandon, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Hradec Králové, Czechia
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Ústí nad Labem, Czechia
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Herlev, Denmark
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Silkeborg, Denmark
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Amiens, France
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Caen, France
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Lille, France
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Marseille, France
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Nantes, France
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Paris, France
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Pessac, France
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Reims, France
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Rouen, France
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Toulouse, France
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Berlin, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Halle, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Jena, Germany
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Kiel, Germany
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Mannheim, Germany
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Minden, Germany
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Münster, Germany
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Regensburg, Germany
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Tübingen, Germany
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Ulm, Germany
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Szekszárd, Hungary
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Akureyri, Iceland
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Reykjavik, Iceland
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Dublin, Ireland
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Jerusalem, Israel
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Tel Litwinsky, Israel
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Chikushino-shi, Japan
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Fukuoka, Japan
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Hamamatsu, Japan
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Kagoshima, Japan
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Nishinomiya, Japan
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Ohtsu, Japan
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Ōita, Japan
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Sakura, Japan
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Sapporo, Japan
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Yokkaichi, Japan
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Amsterdam, 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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Grafton, New Zealand
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Hamilton, New Zealand
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Krakow, Poland
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Lodz, Poland
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Belgrade, Serbia
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Niš, Serbia
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Cape Town, South Africa
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Overport, South Africa
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Seoul, South Korea
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Madrid, Spain
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Sagunto, Spain
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Birmingham, United Kingdom
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Bristol, United Kingdom
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Exeter, United Kingdom
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Harrow, United Kingdom
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London, United Kingdom
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Norwich, United Kingdom
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Oxford, United Kingdom
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Shropshire, United Kingdom
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South Shields, United Kingdom
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Southampton, United Kingdom
Related Publications (14)
Huan PW, Mehta A, Wong ECL, Dulai PS, Marshall JK, Reinisch W, Narula N. A Review of the Modified Multiplier of Simple Endoscopic Score for Crohn's Disease and How to Use It in Clinical Trials and Practice. Am J Gastroenterol. 2025 Oct 1;120(10):2242-2250. doi: 10.14309/ajg.0000000000003373. Epub 2025 Feb 25.
PMID: 39996607DERIVEDGhosh S, Feagan BG, Ott E, Gasink C, Godwin B, Marano C, Miao Y, Ma T, Loftus EV Jr, Sandborn WJ, Danese S, Abreu MT, Sands BE. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis. J Crohns Colitis. 2024 Aug 6;18(7):1091-1101. doi: 10.1093/ecco-jcc/jjae013.
PMID: 38310565DERIVEDColombel JF, Sands BE, Gasink C, Yeager B, Adedokun OJ, Izanec J, Ma T, Gao LL, Lee SD, Targan SR, Ghosh S, Hanauer SB, Sandborn WJ. Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2024 Jan;22(1):144-153.e2. doi: 10.1016/j.cgh.2023.06.014. Epub 2023 Jun 28.
PMID: 37391056DERIVEDDubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27.
PMID: 37368103DERIVEDAdedokun 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: 36150926DERIVEDNarula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.
PMID: 35435862DERIVEDNarula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.
PMID: 34077627DERIVEDSandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236.
PMID: 32964215DERIVEDLi K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.
PMID: 31279870DERIVEDGhosh 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: 30739254DERIVEDRutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.
PMID: 29909019DERIVEDAdedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.
PMID: 29409871DERIVEDHibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.
PMID: 29142515DERIVEDFeagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960. doi: 10.1056/NEJMoa1602773.
PMID: 27959607DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The global study was interrupted due to issues with the clinical supply.
Results Point of Contact
- Title
- Vice President
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 8, 2011
Study Start
July 1, 2011
Primary Completion
June 1, 2013
Study Completion
July 1, 2013
Last Updated
December 7, 2016
Results First Posted
December 7, 2016
Record last verified: 2016-10