AzTrials
AzTrials

Crohn's DiseasePhase 3NCT01369342

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

A Phase 3 study testing Group 2 ustekinumab 130 mg and Group 3: ustekinumab approximately 6 mg/kg in people with Crohn's Disease and Inflammatory Bowel Disease, run by Janssen Research & Development, LLC at 220 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Crohn's Disease, Inflammatory Bowel Disease, IBD
What is being tested?
Group 2 ustekinumab 130 mg and Group 3: ustekinumab approximately 6 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
640 participants
Where
220 sitesin 22 countries
Study dates
Jul 2011to Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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

Who cannot join

  • 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)

Trial locations and contacts

220 sites in 22 countries.

220 sites in 22 countries

United States84 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Athens, Georgia

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beavercreek, Ohio

  • Study site

    Bellevue, Washington

  • Study site

    Bend, Oregon

  • Study site

    Boca Raton, Florida

  • Study site

    Boston, Massachusetts

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chesapeake, Virginia

  • Study site

    Chesterfield, Michigan

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Columbia, Maryland

  • Study site

    Columbia, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Decatur, Georgia

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Gainesville, Florida

  • Study site

    Germantown, Tennessee

  • Study site

    Grapevine, Texas

  • Study site

    Great Neck, New York

  • Study site

    Houma, Louisiana

  • Study site

    Houston, Texas

  • Study site

    Idaho Falls, Idaho

  • Study site

    Jackson, Mississippi

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Largo, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Lees Summit, Missouri

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Lone Tree, Colorado

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Macon, Georgia

  • Study site

    Madison, Wisconsin

  • Study site

    Malvern, Pennsylvania

  • Study site

    Marlton, New Jersey

  • Study site

    Mentor, Ohio

  • Study site

    Miami, Florida

  • Study site

    Morristown, New Jersey

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Norman, Oklahoma

  • Study site

    North Charleston, South Carolina

  • Study site

    Novi, Michigan

  • Study site

    Ocean Springs, Mississippi

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Port Orange, Florida

  • Study site

    Portland, Oregon

  • Study site

    Poughkeepsie, New York

  • Study site

    Pratt, Kansas

  • Study site

    Raleigh, North Carolina

  • Study site

    Rochester, Minnesota

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    Santa Monica, California

  • Study site

    Seattle, Washington

  • Study site

    Topeka, Kansas

  • Study site

    Torrance, California

  • Study site

    Towson, Maryland

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tyler, Texas

  • Study site

    Urbana, Missouri

  • Study site

    Virginia Beach, Virginia

  • Study site

    Winter Park, Florida

  • Study site

    Worcester, Massachusetts

  • Study site

    Ypsilanti, Michigan

Other trials in United States

Japan20 sites

  • Study site

    Chikushino-shi

  • Study site

    Hachiōji

  • Study site

    Hamamatsu

  • Study site

    Hirosaki

  • Study site

    Hiroshima

  • Study site

    Kagoshima

  • Study site

    Nishinomiya

  • Study site

    Ohtsu

  • Study site

    Ōita

  • Study site

    Osaka

  • Study site

    Sakura

  • Study site

    Sapporo

  • Study site

    Sendai

  • Study site

    Suita-Shi

  • Study site

    Tokyo

  • Study site

    Tsu

  • Study site

    Uruma

  • Study site

    Yokkaichi

  • Study site

    Yokohama

  • Study site

    Yokosuka

Other trials in Japan

Germany17 sites

  • Study site

    Berlin

  • Study site

    Bochum

  • Study site

    Frankfurt

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Haßloch

  • Study site

    Heidelberg

  • Study site

    Kiel

  • Study site

    Lÿneburg

  • Study site

    Mannheim

  • Study site

    Minden

  • Study site

    München

  • Study site

    Münster

  • Study site

    Regensburg

  • Study site

    Stade

  • Study site

    Ulm

Other trials in Germany

United Kingdom14 sites

  • Study site

    Birmingham

  • Study site

    Brighton

  • Study site

    Bristol

  • Study site

    Cambridge

  • Study site

    Gloucester

  • Study site

    Harrow

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Norwich

  • Study site

    Nottinghamshirecc

  • Study site

    Oxford

  • Study site

    Shrewsbury

  • Study site

    Southampton

Other trials in United Kingdom

Canada11 sites

  • Study site

    Brandon, Manitoba

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Kingston, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Saskatoon

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg

Other trials in Canada

Australia9 sites

  • Study site

    Adelaide

  • Study site

    Cairns

  • Study site

    Central Queensland M C

  • Study site

    Concord

  • Study site

    Fremantle

  • Study site

    Garran

  • Study site

    Liverpool

  • Study site

    Malvern

  • Study site

    Parkville

Other trials in Australia

Hungary8 sites

  • Study site

    Békéscsaba

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Gyula

  • Study site

    Mosonmagyaróvár

  • Study site

    Pécs

  • Study site

    Székesfehérvár

  • Study site

    Szekszárd

Other trials in Hungary

New Zealand8 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Grafton

  • Study site

    Hamilton

  • Study site

    Hastings

  • Study site

    Plenty

  • Study site

    Wellington

Other trials in New Zealand

France7 sites

  • Study site

    Amiens

  • Study site

    Bordeaux

  • Study site

    Caen

  • Study site

    Lille

  • Study site

    Paris

  • Study site

    Rouen

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Israel7 sites

  • Study site

    Beer Yaakov

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Rehovot

  • Study site

    Tel Aviv

Other trials in Israel

Poland5 sites

  • Study site

    Bydgoszcz

  • Study site

    Elblag

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Warsaw

Other trials in Poland

Brazil4 sites

  • Study site

    Goiânia

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo

Other trials in Brazil

Bulgaria4 sites

  • Study site

    Pleven

  • Study site

    Rousse

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Netherlands4 sites

  • Study site

    Amsterdam

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Maastricht

  • Study site

    Rotterdam

Other trials in Netherlands

Croatia3 sites

  • Study site

    Osijek

  • Study site

    Rijeka

  • Study site

    Zagreb

Other trials in Croatia

South Africa3 sites

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Pretoria

Other trials in South Africa

South Korea3 sites

  • Study site

    Daegu

  • Study site

    Gyeonggi-do

  • Study site

    Seoul

Other trials in South Korea

Spain3 sites

  • Study site

    Madrid

  • Study site

    Sabadell

  • Study site

    Santiago de Compostela

Other trials in Spain

Belgium2 sites

  • Study site

    Brussels

  • Study site

    Leuven

Other trials in Belgium

Russia2 sites

  • Study site

    Moscow

  • Study site

    Novosibirsk

Other trials in Russia

Iceland1 site

  • Study site

    Reykjavik

Other trials in Iceland

Serbia1 site

  • Study site

    Belgrade

Other trials in Serbia

About this study

Official title: 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 (UNITI-2)

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

Read the detailed description

This study (CNTO1275CRD3002 or "UNITI-2") examines ustekinumab (an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23) versus a placebo (otherwise identical except without the ustekinumab antibody) given intravenously (by an IV) in adults with moderately to severely active Crohn's disease. Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study will examine if ustekinumab can provide benefit in Crohn's disease and also assess for any risks or side effects. Both the positive and negative outcomes of IV placebo versus two different doses of IV ustekinumab will be tracked and compared over eight weeks, in approximately 612 patients who have previously failed or were intolerant to corticosteroids or immunomodulators (methotrexate, azathioprine, or 6-mercaptopurine) or are dependent on corticosteroid medications. Patients enrolling in this study will be assigned to one of the 3 treatment groups by chance (randomly, like rolling dice), and all will receive a single IV administration of study agent at the first study visit (after the screening period), and then will be asked to return for 3 additional visits through Week 8. Patients who complete this study through the Week 8 visit and remain eligible can enter the maintenance study (CNTO1275CRD3003 or "IM-UNITI"), where they will receive additional study agent, including the administration of ustekinumab in patients who receive placebo in this study and have not had improvement in their Crohn's disease. Patients who do not enter the CNTO1275CRD3003 study will have a final safety follow-up visit approximately 20 weeks after they received study agent when they entered into this study at the Week 0 visit. .All patients will receive a single intravenous (IV) administration of study drug (placebo or ustekinumab) at the start of the study.There are 3 treatment groups in this study: Group 1: Placebo; Group 2: ustekinumab 130 mg, Group 3: 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).

Being tested
Group 1: Placebo, Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
Keywords
ustekinumab, moderately to severely active Crohn's Disease, Stelara, IBD, colitis, crohn, UNITI, Crohn's
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases, Colitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group 1: PlaceboDrug

    Form=solution for injection, route=intravenous use, in a single dose.

  • Group 2 ustekinumab 130 mgDrug

    Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.

  • Group 3: ustekinumab approximately 6 mg/kgDrug

    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).

Study groups in NCT01369342
Study groupRoleWhat they receive
Placebo IVPlacebo comparatorGroup 1: Placebo Form=solution for injection route=intravenous use in a single dose.
Receives: Drug: Group 1: Placebo
Ustekinumab 130 milligram (mg)ExperimentalGroup 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
Receives: Drug: Group 2 ustekinumab 130 mg
Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg)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).
Receives: Drug: Group 3: ustekinumab approximately 6 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (CDAI) 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 decrease in CDAI score over time indicates improvement in disease activity.

    Measured: Week 6

Secondary outcomes (4)

  1. Number of Participants in Clinical Remission at Week 8

    Clinical remission at Week 8 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points.

    Measured: Week 8

  2. Number of Participants in Clinical Response at Week 8

    Clinical response at Week 8 was defined as a reduction from baseline in the CDAI 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 decrease in CDAI score over time indicates improvement in disease activity.

    Measured: Week 8

  3. Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6

    70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

    Measured: Week 6

  4. Number of Participants With CDAI 70 Point Response at Week 3

    70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.

    Measured: Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionAug 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
640 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01369342
Sponsor's protocol ID
CR018418
Other IDs
CNTO1275CRD3002, 2010-022759-42
Status last verified
Nov 2016
First submitted
7 Jun 2011
Last updated
6 Jan 2017
Data monitoring committee
Yes

Publications

  • Ye BD, Sugimoto K, Cheon JH, Gasink C, Imai Y, Wahking B, Zhuo J, Kawamura S, Hibi T. Efficacy and safety of ustekinumab in Asian patients with moderately to severely active Crohn's disease: a small subpopulation analysis of UNITI/IM-UNITI long-term extension through 5 years. Intest Res. 2026 Jul 10. doi: 10.5217/ir.2025.00285. Online ahead of print.

    PubMed 42427284

  • 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.

    PubMed 38310565

  • 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.

    PubMed 37391056

  • 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.

    PubMed 37368103

  • 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.

    PubMed 36150926

  • 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.

    PubMed 34077627

  • 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.

    PubMed 32964215

  • 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.

    PubMed 31279870

  • 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.

    PubMed 30739254

  • 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.

    PubMed 29909019

  • 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.

    PubMed 29409871

  • 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.

    PubMed 29142515

  • 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.

    PubMed 27959607

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Group 2 ustekinumab 130 mg and Group 3: ustekinumab approximately 6 mg/kg in people with Crohn's Disease and Inflammatory Bowel Disease, run by Janssen Research & Development, LLC at 220 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in United States, Japan, Germany, United Kingdom, Canada and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Response at Week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01369342, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.

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