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Crohn's DiseasePhase 3NCT01369329

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 study testing Group 2 ustekinumab 130 mg and Group 3: ustekinumab approximately 6 mg/kg in people with Crohn's Disease and IBD, run by Janssen Research & Development, LLC at 175 sites in 23 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-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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease, IBD, Colitis
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
769 participants
Where
175 sitesin 23 countries
Study dates
Jul 2011to Jul 2013
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 years and older
  • 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'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.

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

175 sites in 23 countries.

175 sites in 23 countries

United States67 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beavercreek, Ohio

  • Study site

    Bend, Oregon

  • 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

    Cleveland, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Decatur, Georgia

  • Study site

    Evanston, Illinois

  • Study site

    Gainesville, Florida

  • Study site

    Great Neck, New York

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Lebanon, New Hampshire

  • 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

    Marlton, New Jersey

  • Study site

    Morristown, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • 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

    Pittsburgh, Pennsylvania

  • Study site

    Raleigh, North Carolina

  • Study site

    Redwood City, California

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Salt Lake City, Utah

  • Study site

    San Carlos, California

  • Study site

    San Diego, California

  • Study site

    Seattle, Washington

  • Study site

    Springfield, Oregon

  • Study site

    Towson, Maryland

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Tyler, Texas

  • Study site

    Urbana, Missouri

  • Study site

    Virginia Beach, Virginia

  • Study site

    Weston, Florida

  • Study site

    Winter Park, Florida

  • Study site

    Worcester, Massachusetts

Other trials in United States

Germany19 sites

  • Study site

    Berlin

  • Study site

    Erlangen

  • Study site

    Essen

  • Study site

    Frankfurt

  • Study site

    Freiburg im Breisgau

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Jena

  • Study site

    Kiel

  • Study site

    Lÿneburg

  • Study site

    Mannheim

  • Study site

    Minden

  • Study site

    München

  • Study site

    Münster

  • Study site

    Regensburg

  • Study site

    Tübingen

  • Study site

    Ulm

Other trials in Germany

United Kingdom17 sites

  • Study site

    Birmingham

  • Study site

    Brighton

  • Study site

    Bristol

  • Study site

    Cambridge

  • Study site

    Cardiff

  • Study site

    Exeter

  • 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

    Shropshire

  • Study site

    South Shields

  • Study site

    Southampton

Other trials in United Kingdom

Japan12 sites

  • Study site

    Chikushino-shi

  • Study site

    Fukuoka

  • Study site

    Hamamatsu

  • Study site

    Kagoshima

  • Study site

    Nishinomiya

  • Study site

    Ohtsu

  • Study site

    Ōita

  • Study site

    Osaka

  • Study site

    Sakura

  • Study site

    Sapporo

  • Study site

    Tokyo

  • Study site

    Yokkaichi

Other trials in Japan

France10 sites

  • Study site

    Amiens

  • Study site

    Caen

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Reims

  • Study site

    Rouen

  • Study site

    Toulouse

Other trials in France

Canada9 sites

  • Study site

    Brandon, Manitoba

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Kingston, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Australia8 sites

  • Study site

    Bedford Park

  • Study site

    Box Hill

  • Study site

    Central Queensland M C

  • Study site

    Concord

  • Study site

    Garran

  • Study site

    Liverpool

  • Study site

    Malvern

  • Study site

    Parkville

Other trials in Australia

New Zealand4 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Grafton

  • Study site

    Hamilton

Other trials in New Zealand

Austria3 sites

  • Study site

    Innsbruck

  • Study site

    Sankt Pölten

  • Study site

    Vienna

Other trials in Austria

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Netherlands3 sites

  • Study site

    Amsterdam

  • Study site

    Maastricht

  • Study site

    Rotterdam

Other trials in Netherlands

Czechia2 sites

  • Study site

    Hradec Králové

  • Study site

    Ústí nad Labem

Other trials in Czechia

Denmark2 sites

  • Study site

    Herlev

  • Study site

    Silkeborg

Other trials in Denmark

Iceland2 sites

  • Study site

    Akureyri

  • Study site

    Reykjavik

Other trials in Iceland

Israel2 sites

  • Study site

    Jerusalem

  • Study site

    Tel HaShomer

Other trials in Israel

Poland2 sites

  • Study site

    Krakow

  • Study site

    Lodz

Other trials in Poland

Serbia2 sites

  • Study site

    Belgrade

  • Study site

    Niš

Other trials in Serbia

South Africa2 sites

  • Study site

    Cape Town

  • Study site

    Overport

Other trials in South Africa

Spain2 sites

  • Study site

    Madrid

  • Study site

    Sagunto

Other trials in Spain

Brazil1 site

  • Study site

    Rio de Janeiro

Other trials in Brazil

Hungary1 site

  • Study site

    Szekszárd

Other trials in Hungary

Ireland1 site

  • Study site

    Dublin

Other trials in Ireland

South Korea1 site

  • Study site

    Seoul

Other trials in South Korea

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 Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

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).

Read the detailed description

This study (CNTO1275CRD3001 or "UNITI-1") 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 who previously did not respond to, lost response to, or could not tolerate TNF-antagonist medications (specifically, infliximab, adalimumab or certolizumab pegol). 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 703 patients. 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'' [NCT01369355]), 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 (either placebo or ustekinumab) at the first (week 0) visit when they enter the study.There are 3 treatment groups: 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 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg, Group 1: Placebo
Keywords
ustekinumab, moderately to severely active Crohn's Disease, tumor necrosis factor, Stelara, Crohn, Crohn's, IBD, UNITI
Medical subject headings
Crohn Disease, Colitis, Inflammatory Bowel Diseases

What participants receive

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

  • 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).

  • Group 1: PlaceboDrug

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

Study groups in NCT01369329
Study groupRoleWhat they receive
001Placebo comparatorGroup 1: Placebo Form=solution for injection route=intravenous use in a single dose.
Receives: Drug: Group 1: Placebo
002ExperimentalGroup 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
003ExperimentalGroup 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 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.

    Measured: Baseline and Week 6

Secondary outcomes (4)

  1. Number of Participants in Clinical Remission at Week 8

    Clinical remission is defined as a CDAI score of less than (<) 150 points at Week 8.

    Measured: Baseline and 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 Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. 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.

    Measured: Baseline and 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. 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: Baseline and 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. 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: Baseline and 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 completionJun 2013
  4. Study completionJul 2013

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
769 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01369329
Sponsor's protocol ID
CR018415
Other IDs
CNTO1275CRD3001, 2010-022758-18
Status last verified
Oct 2016
First submitted
7 Jun 2011
Last updated
7 Dec 2016
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

  • 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.

    PubMed 39996607

  • 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, 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.

    PubMed 35435862

  • 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 IBD, run by Janssen Research & Development, LLC at 175 sites in 23 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 6 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, Germany, United Kingdom, Japan, France and 18 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 7 Dec 2016). 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: Baseline and 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 NCT01369329, which also lists 15 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 7 Dec 2016.

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