A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
NCT ID: NCT01369342
Last Updated: 2017-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
640 participants
INTERVENTIONAL
2011-07-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo IV
Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
Group 1: Placebo
Form=solution for injection, route=intravenous use, in a single dose.
Ustekinumab 130 milligram (mg)
Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
Group 2 ustekinumab 130 mg
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg)
Group 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).
Group 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
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Group 1: Placebo
Form=solution for injection, route=intravenous use, in a single dose.
Group 2 ustekinumab 130 mg
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
Group 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).
Eligibility Criteria
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Inclusion Criteria
* Have active Crohn's disease, defined as a baseline Crohn Disease Activity Index (CDAI) score of \>= 220 and \<= 450, with confirmation of active inflammation
* Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
* Have screening laboratory test results within protocol-specified parameters
Exclusion Criteria
* 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)
18 Years
99 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Tucson, Arizona, United States
Little Rock, Arkansas, United States
La Jolla, California, United States
Los Angeles, California, United States
San Diego, California, United States
Santa Monica, California, United States
Torrance, California, United States
Lone Tree, Colorado, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Port Orange, Florida, United States
Winter Park, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Clive, Iowa, United States
Pratt, Kansas, United States
Topeka, Kansas, United States
Crestview Hills, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Houma, Louisiana, United States
New Orleans, Louisiana, United States
Chevy Chase, Maryland, United States
Columbia, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Chesterfield, Michigan, United States
Novi, Michigan, United States
Troy, Michigan, United States
Ypsilanti, Michigan, United States
Rochester, Minnesota, United States
Jackson, Mississippi, United States
Ocean Springs, Mississippi, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Lees Summit, Missouri, United States
Urbana, Missouri, United States
Las Vegas, Nevada, United States
Egg Harbor, New Jersey, United States
Marlton, New Jersey, United States
Morristown, New Jersey, United States
Great Neck, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Beavercreek, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Mentor, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bend, Oregon, United States
Portland, Oregon, United States
Malvern, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
North Charleston, South Carolina, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Chesapeake, Virginia, United States
Virginia Beach, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Adelaide, , Australia
Cairns, , Australia
Central Queensland M C, , Australia
Concord, , Australia
Fremantle, , Australia
Garran, , Australia
Liverpool, , Australia
Malvern, , Australia
Parkville, , Australia
Brussels, , Belgium
Leuven, , Belgium
Goiânia, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Pleven, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Brandon, Manitoba, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Saskatoon, , Canada
Winnipeg, , Canada
Osijek, , Croatia
Rijeka, , Croatia
Zagreb, , Croatia
Amiens, , France
Bordeaux, , France
Caen, , France
Lille, , France
Paris, , France
Rouen, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Bochum, , Germany
Frankfurt, , Germany
Halle, , Germany
Hamburg, , Germany
Hanover, , Germany
Haßloch, , Germany
Heidelberg, , Germany
Kiel, , Germany
Lÿneburg, , Germany
Mannheim, , Germany
Minden, , Germany
München, , Germany
Münster, , Germany
Regensburg, , Germany
Stade, , Germany
Ulm, , Germany
Békéscsaba, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Mosonmagyaróvár, , Hungary
Pécs, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Reykjavik, , Iceland
Beer Yaakov, , Israel
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Chikushino-shi, , Japan
Hachiōji, , Japan
Hamamatsu, , Japan
Hirosaki, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Nishinomiya, , Japan
Ohtsu, , Japan
Osaka, , Japan
Ōita, , Japan
Sakura, , Japan
Sapporo, , Japan
Sendai, , Japan
Suita-Shi, , Japan
Tokyo, , Japan
Tsu, , Japan
Uruma, , Japan
Yokkaichi, , Japan
Yokohama, , Japan
Yokosuka, , Japan
Amsterdam, , Netherlands
Amsterdam-Zuidoost, , Netherlands
Maastricht, , Netherlands
Rotterdam, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Grafton, , New Zealand
Hamilton, , New Zealand
Hastings, , New Zealand
Plenty, , New Zealand
Wellington, , New Zealand
Bydgoszcz, , Poland
Elblag, , Poland
Krakow, , Poland
Lodz, , Poland
Warsaw, , Poland
Moscow, , Russia
Novosibirsk, , Russia
Belgrade, , Serbia
Cape Town, , South Africa
Durban, , South Africa
Pretoria, , South Africa
Daegu, , South Korea
Gyeonggi-do, , South Korea
Seoul, , South Korea
Madrid, , Spain
Sabadell, , Spain
Santiago de Compostela, , Spain
Birmingham, , United Kingdom
Brighton, , United Kingdom
Bristol, , United Kingdom
Cambridge, , United Kingdom
Gloucester, , United Kingdom
Harrow, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Norwich, , United Kingdom
Nottinghamshirecc, , United Kingdom
Oxford, , United Kingdom
Shrewsbury, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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Ghosh 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.
Colombel 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.
Dubinsky 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.
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.
Narula 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.
Sandborn 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.
Li 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.
Ghosh 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.
Rutgeerts 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.
Adedokun 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.
Hibi 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.
Feagan 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.
Other Identifiers
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CNTO1275CRD3002
Identifier Type: OTHER
Identifier Source: secondary_id
2010-022759-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR018418
Identifier Type: -
Identifier Source: org_study_id
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