AzTrials
AzTrials

Crohn's DiseasePhase 3NCT01369355

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

A Phase 3 study testing Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV and Ustekinumab 90 mg SC q12w in people with Crohn's Disease and Colitis, run by Janssen Research & Development, LLC at 220 sites in 26 countries.

Completed

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

Official record
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Trial summary

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Crohn's Disease, Colitis, IBD
What is being tested?
Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV and Ustekinumab 90 mg SC q12w
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,282 participants
Where
220 sitesin 26 countries
Study dates
13 Sep 2011to 1 Oct 2019
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

  • Patients who received study agent at the start of study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:
  • Patients who underwent a Crohn's disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002
  • Patients who started a protocol prohibited medication since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002
  • Patients with protocol-specified changes to their concomitant medications due to Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002

Who cannot join

None listed.

Trial locations and contacts

220 sites in 26 countries.

220 sites in 26 countries

United States77 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

    Bend, Oregon

  • Study site

    Boca Raton, Florida

  • Study site

    Boston, Massachusetts

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South 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

    Columbia, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Decatur, Georgia

  • Study site

    Detroit, Michigan

  • Study site

    Evanston, Illinois

  • Study site

    Gainesville, Florida

  • Study site

    Grapevine, Texas

  • Study site

    Great Neck, New York

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Idaho Falls, Idaho

  • Study site

    Jackson, Mississippi

  • Study site

    Jacksonville, Florida

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lee's Summit, Missouri

  • Study site

    Lexington, Kentucky

  • 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

    Mentor, Ohio

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    North Charleston, South Carolina

  • Study site

    Ocean Springs, Mississippi

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Poughkeepsie, New York

  • Study site

    Pratt, Kansas

  • Study site

    Raleigh, North Carolina

  • 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

    Santa Monica, California

  • Study site

    Seattle, Washington

  • 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

  • Study site

    Ypsilanti, Michigan

Other trials in United States

Japan21 sites

  • Study site

    Chikushino-shi

  • Study site

    Fukuoka

  • 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

Germany18 sites

  • Study site

    Berlin

  • Study site

    Erlangen

  • Study site

    Frankfurt

  • Study site

    Freiburg im Breisgau

  • Study site

    Halle

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Haßloch

  • Study site

    Heidelberg

  • Study site

    Jena

  • Study site

    Kiel

  • Study site

    LÿNEBURG

  • Study site

    Mannheim

  • Study site

    München

  • Study site

    Münster

  • Study site

    Regensburg

  • Study site

    Stade

  • Study site

    Ulm

Other trials in Germany

United Kingdom15 sites

  • Study site

    Birmingham

  • Study site

    Brighton

  • Study site

    Bristol

  • Study site

    Cambridge

  • Study site

    Cardiff

  • Study site

    Exeter

  • Study site

    Gloucester

  • Study site

    Liverpool

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Norwich

  • Study site

    Nottinghamshirecc

  • Study site

    Oxford

  • Study site

    Shropshire

  • Study site

    Southampton

Other trials in United Kingdom

Canada11 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

    Saskatoon, Saskatchewan

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Australia9 sites

  • Study site

    Adelaide

  • 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

France8 sites

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Reims

  • Study site

    Rouen

  • Study site

    Toulouse

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

Hungary7 sites

  • Study site

    Békéscsaba

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Mosonmagyaróvár

  • Study site

    Pécs

  • Study site

    Székesfehérvár

  • Study site

    Szeksz Rd N/a

Other trials in Hungary

Israel7 sites

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Rehovot

  • Study site

    Tel Aviv

  • Study site

    Tzrifin

Other trials in Israel

New Zealand7 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Grafton

  • Study site

    Hamilton

  • Study site

    Hastings

  • Study site

    Plenty

Other trials in New Zealand

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

Poland4 sites

  • Study site

    Elblag

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Warsaw

Other trials in Poland

South Africa4 sites

  • Study site

    Cape Town

  • Study site

    Cape Town Western Cape

  • Study site

    Pretoria

  • Study site

    Somerset West

Other trials in South Africa

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

Russia3 sites

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Saint Petersburg

Other trials in Russia

South Korea3 sites

  • Study site

    Daegu

  • Study site

    Gyeonggi-do

  • Study site

    Seoul

Other trials in South Korea

Austria2 sites

  • Study site

    Innsbruck

  • Study site

    Vienna

Other trials in Austria

Croatia2 sites

  • Study site

    Rijeka

  • Study site

    Zagreb

Other trials in Croatia

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

Iceland1 site

  • Study site

    Reykjavik

Other trials in Iceland

Ireland1 site

  • Study site

    Dublin

Other trials in Ireland

Serbia1 site

  • Study site

    Belgrade

Other trials in Serbia

Spain1 site

  • Study site

    Madrid

Other trials in Spain

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 Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

Read the detailed description

The main purpose of this study is to determine whether additional ustekinumab treatment is beneficial in patients with moderately to severely active Crohn's disease who initially had a clinical response to IV ustekinumab in one of the 2 initial induction studies (the CNTO1275CRD3001 ["UNITI-1"] or CNTO1275CRD3002 ["UNITI-2"] induction studies). The maintenance treatment will be injections in the skin (given subcutaneously, or "SC") of 90 mg ustekinumab either every 8 weeks or 12 weeks, and the effects (both the benefits and any side effects or adverse events) will be compared to SC placebo injections (otherwise identical except without ustekinumab). Patients who responded to IV ustekinumab in the UNITI-1 (NCT01369329) or UNITI-2 (NCT01369342) induction studies will be put into one of these 3 groups by chance (randomly, like rolling dice). The study will be double-blinded (so that neither patients nor study personnel know the identity of the assigned treatment). Patients who are randomized to either SC placebo or 90mg ustekinumab SC every 12 weeks who experience worsening in their Crohn's Disease symptoms (per the study loss of response criteria) will have their treatment adjusted so that they will instead start to receive 90mg ustekinumab SC every 8 weeks. All patients from the UNITI-1 or UNITI-2 studies (in addition to the patients described above who responded to IV ustekinumab) will be eligible to enter this study, provided the Week 8 visit in those trials was completed and study requirements are still met. Patients who are not in clinical response to IV placebo or ustekinumab in UNITI-1 or UNITI-2 will receive both IV and SC study agent at the first visit of this study (week 0). Patients previously receiving IV placebo will receive ustekinumab 130 mg IV at week 0 (and SC placebo), and patients previously receiving IV ustekinumab will receive 90 mg ustekinumab SC at week 0 (as well as IV placebo). If these patients are in clinical response 8 weeks later, they will receive 90 SC ustekinumab at that week8 visit, and will continue to receive Ustekinumab (every 8 weeks for participants not in response to IV Ustekinumab and every 12 weeks for participants not in response to IV Placebo) throughout the rest of the study (provided they otherwise remain eligible). Patients in clinical response to IV placebo induction dosing will continue to receive SC placebo. The main part of this study, also called the maintenance portion, will last 44 weeks. After week 44, all participants who are continuing to do well will be eligible to continue to receive study agent in the second part of the study, a long term extension where the study agent will continue to be administered up to week 252. Participants who discontinue study agent, either during the study, or after week 252, will be asked to return for a final safety follow-up visit 20 weeks after they last received study agent.

Patients in response to IV ustekinumab will be randomized to receive either placebo (Group 1), Ustekinumab 90 mg SC every 12 weeks (Group 2), or Ustekinumab 90mgSC every 8 weeks (Group 3). If patients in Groups 1 or 2 lose response, they will cross over to receive ustekinumab 90mg every 8 weeks. Other populations (nonresponders to prior IV ustekinumab or IV placebo) will receive ustekinumab at Week0 (either 90mg SC or 130mg IV, respectively) and continue SC ustekinumab if in response at Week 8, Placebo IV responders will continue to receive Placebo SC q4w.

Being tested
Placebo SC, Placebo IV, Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV, Ustekinumab 90 mg SC q12w
Keywords
Ustekinumab, Stelara, Moderately to severely active Crohn's Disease, IBD, Crohn's, UNITI, colitis, IL-12, IL-23
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.

  • Placebo SCDrug

    Placebo will be administered subcutaneously.

  • Placebo IVDrug

    Placebo will be administered as a single Intravenous infusion at week 0.

  • Ustekinumab 90 mg SC q8wDrug

    Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.

  • Ustekinumab 130 mg IVDrug

    Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.

  • Ustekinumab 90 mg SC q12wDrug

    Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.

Study groups in NCT01369355
Study groupRoleWhat they receive
001Placebo comparatorParticipants who were responders to Intravenous (IV) infusion of ustekinumab induction will be randomized to receive a single dose of placebo subcutaneously (SC) every 4 weeks (q4w).
Receives: Drug: Placebo SC
002ExperimentalParticipants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 milligram (mg) SC every 12 weeks (q12w).
Receives: Drug: Ustekinumab 90 mg SC q12w
003ExperimentalParticipants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 mg SC every 8 weeks (q8w).
Receives: Drug: Ustekinumab 90 mg SC q8w
004ExperimentalParticipants who were nonresponders to IV ustekinumab induction will receive a single dose of ustekinumab 90 mg SC and one placebo IV at week 0, if then respond will continue to receive one ustekinumab 90 mg SC q8w.
Receives: Drug: Placebo IV; Drug: Ustekinumab 90 mg SC q8w
005ExperimentalParticipants who were nonresponders to IV placebo induction will receive a single dose of ustekinumab 130 mg IV and one placebo SC at week 0, if then respond will continue to receive one ustekinumab 90 mg SC at week 8 then q12w.
Receives: Drug: Placebo SC; Drug: Ustekinumab 130 mg IV; Drug: Ustekinumab 90 mg SC q12w
006Placebo comparatorParticipants who were responders to IV placebo induction will receive one dose of placebo SC q4w.
Receives: Drug: Placebo SC

What is being measured

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

  1. Number of Participants With Clinical Remission at Week 44

    Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.

    Measured: Week 44

Secondary outcomes (4)

  1. Number of Participants With Clinical Response at Week 44

    Clinical response at Week 44 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: Week 44

  2. Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study

    Clinical remission at week 44 was defined as a CDAI score of < 150 points among participants in clinical remission to ustekinumab at week 0 of maintenance study.

    Measured: Week 44

  3. Number of Participants With Corticosteroid-free Remission at Week 44

    Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44.

    Measured: Week 44

  4. Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy

    Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.

    Measured: Week 44

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 start13 Sep 2011
  3. Primary completion10 Jun 2015
  4. Study completion1 Oct 2019

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
1,282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01369355
Sponsor's protocol ID
CR018421
Other IDs
CNTO1275CRD3003, 2010-022760-12
Status last verified
Jan 2025
First submitted
7 Jun 2011
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated device
No

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

  • Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.

    PubMed 40357993

  • 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, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG, Lynch JP. Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn's Disease: The IM-UNITI Trial. Clin Gastroenterol Hepatol. 2022 Mar;20(3):578-590.e4. doi: 10.1016/j.cgh.2021.02.025. Epub 2021 Feb 19.

    PubMed 33618023

  • 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

  • Hanauer SB, Sandborn WJ, Feagan BG, Gasink C, Jacobstein D, Zou B, Johanns J, Adedokun OJ, Sands BE, Rutgeerts P, de Villiers WJS, Colombel JF, Ghosh S. IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn's Disease. J Crohns Colitis. 2020 Jan 1;14(1):23-32. doi: 10.1093/ecco-jcc/jjz110.

    PubMed 31158271

  • 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

  • Sandborn WJ, Rutgeerts P, Gasink C, Jacobstein D, Zou B, Johanns J, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG. Long-term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy. Aliment Pharmacol Ther. 2018 Jul;48(1):65-77. doi: 10.1111/apt.14794. Epub 2018 May 24.

    PubMed 29797519

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV and Ustekinumab 90 mg SC q12w in people with Crohn's Disease and Colitis, run by Janssen Research & Development, LLC at 220 sites in 26 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 0 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 4 Feb 2025. 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 21 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 23 Feb 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 Remission at Week 44 (time frame: Week 44). 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 NCT01369355, which also lists 17 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 4 Feb 2025.

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