AzTrials
AzTrials

Crohn DiseasePhase 3SEAVUENCT03464136

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

A Phase 3 study testing Ustekinumab (6 mg/kg), Ustekinumab (90 mg) and Adalimumab (40 mg) in people with Crohn Disease, run by Janssen Scientific Affairs, LLC at 182 sites in 18 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 purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Ustekinumab (6 mg/kg), Ustekinumab (90 mg) and Adalimumab (40 mg)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
386 participants
Where
182 sitesin 18 countries
Study dates
29 Mar 2018to 21 May 2021
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

  • Has Crohn's Disease (CD) or fistulizing CD of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
  • Has moderately-to-severely active CD with a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450
  • Has one or more ulceration on screening ileocolonoscopy (which by definition, would result in an Simple Endoscopic Score for Crohn's Disease [SES-CD] of at least 3)
  • Has failed or was intolerant to conventional therapy (corticosteroids, azathioprine [AZA], 6-mercaptopurine [6-MP] and/or methotrexate [MTX]) at adequate doses or is corticosteroid dependent
  • Has not previously received an approved biologic for Crohn's Disease (i.e., infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or approved biosimilars of these agents)
  • Participants on oral corticosteroids (e.g., prednisone, budesonide) at a prednisone-equivalent dose of <=40 or milligram/day (mg/day) or <=9 mg/day of budesonide are budesonide <=9 mg/day are permitted if doses are stable for 3 weeks prior to baseline
  • Participants on AZA, 6-MP, or MTX at screening (or recently prior), must discontinue these medications at least 3 weeks prior to baseline

Who cannot join

  • Has complications of CD that are likely to require surgery or would confound the ability to assess the effect of ustekinumab or adalimumab treatment using the CDAI, such as: active stoma; short-gut syndrome and severe or symptomatic strictures or stenosis
  • Currently has, or is suspected to have, an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior for intra-abdominal abscesses, if there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present
  • Has had any kind of bowel resection within 6 months prior to baseline or other intra-abdominal surgery or a hospital admission for bowel obstruction within 3 months prior to baseline
  • Has a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
  • Has received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 2 weeks of baseline
  • Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or infected skin wounds or ulcers

Trial locations and contacts

182 sites in 18 countries.

182 sites in 18 countries

United States67 sites

  • Digestive Health Partners

    Asheville, North Carolina, 28801

  • Texas Digestive Disease Consultants

    Baton Rouge, Louisiana, 70809

  • Northshore Gastroenterology Research, LLC

    Beachwood, Ohio, 44122

  • Washington Gastroenterology, PLLC

    Bellevue, Washington, 98004

  • Gastro Associates of Fairfield County PC

    Bridgeport, Connecticut, 06606

  • Saratoga Schenectady Gastroenterology Associates

    Burnt Hills, New York, 12027

  • Aztec Clinical Research, Inc.

    Channelview, Texas, 77530

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • TriHealth Digestive Institute

    Cincinnati, Ohio, 45242

  • Gastro Florida

    Clearwater, Florida, 33756

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Ohio State University Hospital

    Columbus, Ohio, 43210

  • Tri-State Gastroenterology Assoc

    Crestview Hills, Kentucky, 41017

  • Western Connecticut Health Network/Danbury Hospital

    Danbury, Connecticut, 06810

  • Dayton Gastroenterology, Inc

    Dayton, Ohio, 45440

  • Verity Research, Inc

    Fairfax, Virginia, 22031

  • Fargo Gastroenterology Clinic, PC

    Fargo, North Dakota, 58103

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • DHAT Research Institute

    Garland, Texas, 75044

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Gastroenterology Associates P.A.

    Greenville, South Carolina, 29615

  • Gastroenterology Associates Of Hazard

    Hazard, Kentucky, 41701

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • CroNOLA, LLC

    Houma, Louisiana, 70360

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas at Houston Medical School

    Houston, Texas, 77030

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho, 83404

  • Florida Center For Gastroenterology

    Largo, Florida, 33777

  • University of Louisville

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Virginia

    Lynchburg, Virginia, 24502

  • Center for Advanced Gastroenterology

    Maitland, Florida, 32751

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Alabama Medical Group

    Mobile, Alabama, 36608

  • Gastroenterology Group Of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Weill Cornell Medical College

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Digestive And Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73112

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212-4756

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Premier Medical Group Of The Hudson Valley, Pc

    Poughkeepsie, New York, 12601

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Duke University Hospital Medical Center

    Raleigh, North Carolina, 27609

  • McGuire VAMC

    Richmond, Virginia, 23229

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Gastroenterology Research of America, LLC

    San Antonio, Texas, 78229

  • Precision Research Institute

    San Diego, California, 92114

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Saint Louis University Hospital

    St Louis, Missouri, 63104

  • Mercy Clinic East Community

    St Louis, Missouri, 63141

  • Virginia Gastroenterology Institute

    Suffolk, Virginia, 23434

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Washington Gastroenterology, PLLC

    Tacoma, Washington, 98405

  • Apex Clinical Research

    Tampa, Florida, 33612

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Wilmington Gastroenterology Associates

    Wilmington, North Carolina, 28403

  • Huron Gastroenterology Associates Center for Digestive Care

    Ypsilanti, Michigan, 48197

Other trials in United States

Poland13 sites

  • Gastromed Kralisz Romatowski Stachurska Sp. j.

    Bialystok, 15-322

  • Synexus Polska Sp z o o

    Gdansk, 80 382

  • Centrum Medyczne Plejady

    Krakow, 30 363

  • Centrum Medyczne Pratia Poznan

    Krakow, 30510

  • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

    Lodz, 90-153

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Oddzial Gastroenterologii

    Lublin, 20 954

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • Endoskopia Sp z o o z siedziba w Sopocie

    Sopot, 81 756

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

  • Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz

    Warsaw, 03 580

  • Gabinety Lekarskie Bodyclinic

    Warsaw, 03-712

  • Melita Medical Sp. z o.o.

    Wroclaw, 50 449

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

Italy11 sites

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • AOU Policlinico G.Martino

    Messina, 98125

  • ASST Fatebenefratelli Sacco

    Milan, 20157

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Azienda Ospedaliera G.Salvini Ospedale di Rho

    Rho

  • Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

    Roma, 00133

  • Azienda Complesso Ospedaliero San Filippo Neri

    Roma, 00135

  • Fondazione Policlinico Gemelli Università Cattolica

    Roma, 168

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • AO Ordine Mauriziano

    Torino, 10128

Other trials in Italy

Spain10 sites

  • Hosp. Del Mar

    Barcelona, 08003

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007

  • Hosp. Univ. Central de Asturias

    Oviedo, 33011

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Univ. Rio Hortega

    Valladolid, 47012

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Brazil8 sites

  • Hospital Das Clinicas Da Ufmg

    Belo Horizonte - MG, 30130-100

  • Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro

    Goiânia, 74535-170

  • Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida

    Juiz de Fora, 36033-318

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

    Ribeirão Preto, 14098-900

  • Universidade Federal do Rio de Janeiro - Faculdade de Medicina

    Rio de Janeiro, 21941-590

  • Hospital Copa D'Or

    Rio de Janeiro, CEP: 22031-010

  • Fundacao do ABC Centro Universitario FMABC

    Santo André, 09060 870

Other trials in Brazil

Russia8 sites

  • Irkutsk State Medical Academy of Postgraduate Education

    Irkutsk, 664079

  • GU Moscow Regional Research Clinical Institute n.a. M.F.Vla

    Moscva, 129090

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • Elizavetinskaya hospital

    Saint Petersburg, 195257

  • City Clinical Hospital #31

    Saint Petersburg, 197110

  • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

    Ufa, 450005

  • City Clinical Hospital # 21

    Ufa, 450071

  • OOO MO New Hospital

    Yekaterinburg, 620109

Other trials in Russia

Netherlands7 sites

  • VUMC Amsterdam

    Amsterdam, 1081 HV

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD

  • UMCG

    Groningen, 9713 GZ

  • Leiden University Medical Center

    Leiden, 2333 ZA

  • Radboudumc

    Nijmegen, 6525 GA

  • Sint Franciscus Gasthuis

    Rotterdam, 3045 PM

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

Other trials in Netherlands

South Korea7 sites

  • Yeungnam University Hospital

    Daegu, 42415

  • The Catholic university of Korea, St. Vincent's Hospital

    Gyeonggi-do, 16247

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Severance Hospital Yonsei University Health System

    Seoul, 120-752

Other trials in South Korea

United Kingdom7 sites

  • Royal United Hospital

    Bath, BA1 3NG

  • Pennine Acute Hospitals-Fairfield General Hospital

    Bury, BL9 7TD

  • Kingston Hospital

    Kingston upon Thames, KT2 7QB

  • Guy's and St Thomas' Hospital

    London, SE1 7EH

  • St George's Hospital

    London, SW17 0QT

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

  • Musgrove Park Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

France6 sites

  • CHU Amiens

    Amiens, 80054

  • CHRU Montpellier - Hopital Saint-Eloi

    Montpellier, 34295

  • Hotel Dieu

    Nantes, 44035

  • Hopital Saint Louis

    Paris, 75010

  • CHU Saint Etienne

    Saint-Priest-en-Jarez, 42270

  • Clinique Ambroise Pare

    Toulouse, 31082

Other trials in France

Hungary6 sites

  • Réthy Pál Kórház - Rendelőintézet

    Békéscsaba, H-5600

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1134

  • Semmelweis Egyetem

    Budapest, H-1088

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, H-4032

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, H-9700

Other trials in Hungary

Serbia6 sites

  • Clinical Hospital Center Zemun

    Belgrade, 11080

  • Clinical Hospital Center Zvezdara

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • University Clinical Center NIS

    Niš, 18000

  • Clinical Center of Vojvodina

    Vojvodina, 21000

  • Clinical Hospital Center Bezanijska Kosa

    Zemun, 11080

Other trials in Serbia

Australia5 sites

  • Monash Health, Monash Medical Centre

    Clayton, 3168

  • Alfred Hospital

    Melbourne, 3004

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    South Brisbane, 4101

  • St John of God Subiaco Hospital

    Subiaco, 6008

  • The Queen Elizabeth Hospital

    Woodville South, 5011

Other trials in Australia

Canada5 sites

  • University of Calgary

    Calgary, Alberta, T2N4Z6

  • CISSS de la Monteregie Centre

    Greenfield Park, Quebec, J4V 2H1

  • McMaster University

    Hamilton, Ontario, L8S 4K1

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • CMIIM, Centre médical L'Enjeu

    Mount Royal, Quebec, H7P 3E5

Other trials in Canada

Czechia5 sites

  • Fakultní nemocnice u sv. Anny v Brn

    Brno, 656 91

  • Nemocnice Horovice, a.s.

    Hořovice, 268 31

  • Hepato-gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • ISCARE a.s.

    Prague, 190 00

Other trials in Czechia

Bulgaria4 sites

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • MHAT Rousse

    Rousse, 7002

  • 2-nd MHAT

    Sofia, 1202

  • Diagnostic Consulting Center Mladost - M Varna

    Varna, 9020

Other trials in Bulgaria

Germany4 sites

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios Westklinikum

    Hamburg, 22559

  • Uniklinikum Heidelberg

    Heidelberg, 69120

  • MVZ Portal10

    Münster, 48151

Other trials in Germany

Belgium3 sites

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHwapi

    Tournai, 7500

Other trials in Belgium

About this study

Official title: A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

Read the detailed description

This study compares the safety and efficacy of ustekinumab versus adalimumab. It will consist of screening (within 1- 5 weeks prior to Week 0), treatment phase (Weeks 0 to 52), and follow-up phase (up to Week 76). The primary hypothesis is that ustekinumab is superior to adalimumab as measured by clinical remission after one year of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy; CD-related healthcare utilization; patient-reported outcomes (PROs); laboratory evaluations; biomarkers; review of concomitant medications and adverse events (AEs); and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will randomly be assigned to receive either ustekinumab or adalimumab. No participants will be treated with placebo only.

Conditions
Crohn Disease
Being tested
Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)
Medical subject headings
Crohn Disease

What participants receive

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

  • Placebo for UstekinumabBiological

    Participants will receive placebo as SC injection to blind adalimumab.

  • Placebo for AdalimumabBiological

    Participants will receive placebo as IV infusion to blind ustekinumab.

  • Ustekinumab (6 mg/kg)Biological

    Also called Stelara

    Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.

  • Ustekinumab (90 mg)Biological

    Also called Stelara

    Participants will self-administer SC injection of ustekinumab 90 mg.

  • Adalimumab (40 mg)Biological

    Also called Humira

    Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.

Study groups in NCT03464136
Study groupRoleWhat they receive
Group 1 (Ustekinumab)ExperimentalParticipants will receive intravenous (IV) infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 subcutaneous (SC) injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants will self-administer one SC injection of ustekinumab 90 milligram (mg) every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated every 2 weeks (q2w) dosing intervals.
Receives: Biological: Placebo for Ustekinumab; Biological: Ustekinumab (6 mg/kg); Biological: Ustekinumab (90 mg)
Group 2 (Adalimumab)Active comparatorParticipants will receive IV infusion of placebo for ustekinumab and 4 SC injections of adalimumab (each 40 mg, total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants will self-administer 1 SC injection of adalimumab 40 mg q2w.
Receives: Biological: Placebo for Adalimumab; Biological: Adalimumab (40 mg)

What is being measured

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

  1. Percentage of Participants With Clinical Remission at Week 52

    Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (<) 150 points (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 52

Secondary outcomes (17)

  1. Percentage of Participants With Corticosteroid-free Remission at Week 52

    Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score <150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Measured: Week 52

  2. Percentage of Participants With Clinical Response at Week 52

    Percentage of participants with clinical response at Week 52 were assessed. Clinical response at Week 52 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Measured: Week 52

  3. Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52

    PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP <=1 and SF <=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease.

    Measured: Week 52

  4. Percentage of Participants With Clinical Remission at Week 16

    Percentage of participants with clinical remission (defined as CDAI <150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of < 150 points (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 16

  5. Percentage of Participants With Endoscopic Remission at Week 52

    Percentage of participants with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score less than or equal to (<=) 3, or SES-CD =0 for participants who entered the study with a SES-CD =3 at Week 52. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis) each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

    Measured: Week 52

  6. Percentage of Participants With Clinical Remission Through Week 52

    Percentage of participants with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of <150 points (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: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

  7. Percentage of Participants With Clinical Response Through Week 52

    Percentage of participants with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of >=100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Measured: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

  8. Percentage of Participants With Durable Clinical Response at Week 52

    Percentage of participants with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI <150 at Week 52 and was >= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Measured: Week 52

  9. Percentage of Participants With Durable Clinical Remission at Week 52

    Percentage of participants with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score <150 at Week 52 and was >= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Measured: Week 52

  10. Percentage of Participants With Abdominal Pain (AP) Improvement Through Week 52

    Percentage of participants with AP improvement through Week 52 were reported. AP improvement was defined as at least 1 point or greater improvement in mean daily CDAI AP score (ranges from 0 to 3 where higher score indicates severity of pain) from baseline, or a mean score of zero among participants with mean AP>0 at baseline, compared at each visit through Week 52.

    Measured: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

  11. Percentage of Participants With Reduction in Frequency of Diarrhea Through Week 52

    Number of participants with reduction in frequency of diarrhea were reported. Reduction in frequency of diarrhea was defined as a reduction of at least 3 (or a mean number <1) in SF (that is, mean daily number of liquid or very soft stools from CDAI score [ranges from 0 to 3 where higher score indicates severity of pain] in the week prior to the visit) from baseline, among subjects with mean SF >1 at baseline, compared at each visit through Week 52.

    Measured: Weeks 2, 8, 16, 24, 32, 40, 48, and 52

  12. Percentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52

    Percentage of participants with clinical and biomarker remission was defined as the percentage of participants with CDAI <150, CRP <= 3 mg/L, and also fecal calprotectin <=250 micrograms per gram (mcg/g). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.

    Measured: At Weeks 8, 16 and 52

  13. Percentage of Participants With Adverse Events (AEs)

    Percentage of participants with AE were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to Week 52 and up to Week 76

  14. Percentage of Participants With Infections

    Percentage of participants with infections were reported.

    Measured: Up to Week 52 and up to Week 76

  15. Percentage of Participants With Serious Infections

    Percentage of participants with serious infections were reported.

    Measured: Up to Week 52 and up to Week 76

  16. Percentage of Participants With Serious Adverse Events (SAEs)

    Percentage of participants with SAEs were reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Coronavirus disease 2019 (COVID-19) related adverse events are adverse events with any of the following preferred terms "COVID-19", "Asymptomatic COVID-19", "Suspected COVID-19", "COVID-19 pneumonia", "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive" or with a reported term containing the string "COVI.

    Measured: Up to Week 52 and up to Week 76

  17. Percentage of Participants With Anti-drug Antibodies

    Percentage of participants with anti-drug antibodies were reported. Serum samples were assessed for anti-drug antibodies. Anti-drug assays were performed for ustekinumab and adalimumab.

    Measured: Up to Week 52

Timeline

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

  1. First posted13 Mar 2018
  2. Study start29 Mar 2018
  3. Primary completion15 Dec 2020
  4. Study completion21 May 2021

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
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03464136
Sponsor's protocol ID
CR108449
Other IDs
2017-004209-41, CNTO1275CRD3007, 2017
Acronym
SEAVUE
Status last verified
Apr 2025
First submitted
7 Mar 2018
Last updated
29 Apr 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Venkat S, Zeeman M, Hart A, Bhagat S, Galbraith DA, Hoops T, Ufberg PJ, Izanec J, Freeman TC, Mcrae B, Shinzaki S, Jairath V, Panaccione R, Sands BE, Branigan P. Serum protein profiles differ with adalimumab and ustekinumab treatment in moderately to severely active Crohn's disease. J Crohns Colitis. 2025 Dec 5;19(11):jjaf197. doi: 10.1093/ecco-jcc/jjaf197.

    PubMed 41258994

  • 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

  • Sands BE, Irving PM, Hoops T, Izanec JL, Gao LL, Gasink C, Greenspan A, Allez M, Danese S, Hanauer SB, Jairath V, Kuehbacher T, Lewis JD, Loftus EV Jr, Mihaly E, Panaccione R, Scherl E, Shchukina OB, Sandborn WJ; SEAVUE Study Group. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022 Jun 11;399(10342):2200-2211. doi: 10.1016/S0140-6736(22)00688-2.

    PubMed 35691323

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab (6 mg/kg), Ustekinumab (90 mg) and Adalimumab (40 mg) in people with Crohn Disease, run by Janssen Scientific Affairs, LLC at 182 sites in 18 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 7 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States, Poland, Italy, Spain, Brazil and 13 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. 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 11 Jan 2022). 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?

Percentage of Participants With Clinical Remission at Week 52 (time frame: Week 52). 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 NCT03464136, which also lists 3 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 29 Apr 2025.

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