Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year (SEAVUE)

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Biological: Placebo for Ustekinumab; Biological: Ustekinumab (6 mg/kg); Biological: Ustekinumab (90 mg); Biological: Placebo for Adalimumab; Biological: Adalimumab (40 mg)

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.

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Clayton, Australia, 3168
    • Monash Health, Monash Medical Centre
  • Melbourne, Australia, 3004
    • Alfred Hospital
  • South Brisbane, Australia, 4101
    • Mater Hospital Brisbane Inflammatory Bowel Diseases
  • Subiaco, Australia, 6008
    • St John of God Subiaco Hospital
  • Woodville South, Australia, 5011
    • The Queen Elizabeth Hospital
• Belgium
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Tournai, Belgium, 7500
    • CHwapi
• Brazil
  • Belo Horizonte - MG, Brazil, 30130-100
    • Hospital das Clinicas da UFMG
  • Goiania, Brazil, 74535-170
    • Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
  • Juiz de Fora, Brazil, 36033-318
    • Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida
  • Porto Alegre, Brazil, 90035-903
    • Hospital das Clinicas de Porto Alegre
  • Ribeirao Preto, Brazil, 14098-900
    • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
  • Rio de Janeiro, Brazil, CEP: 22031-010
    • Hospital Copa D'Or
  • Rio de Janeiro, Brazil, 21941-590
    • Universidade Federal do Rio de Janeiro - Faculdade de Medicina
  • Santo Andre, Brazil, 09060 870
    • Fundacao do ABC Centro Universitario FMABC
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Rousse, Bulgaria, 7002
    • MHAT Rousse
  • Sofia, Bulgaria, 1202
    • 2-nd MHAT
  • Varna, Bulgaria, 9020
    • Diagnostic Consulting Center Mladost - M Varna
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4Z6
      • University of Calgary
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CISSS de la Monteregie Centre
    • Mont-Royal, Quebec, Canada, H7P 3E5
      • CMIIM, Centre médical L'Enjeu
• Czechia
  • Brno, Czechia, 656 91
    • Fakultní Nemocnice u sv. Anny v Brn
  • Horovice, Czechia, 268 31
    • Nemocnice Horovice, a.s.
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.
  • Praha 10, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 9, Czechia, 190 00
    • ISCARE a.s.
• France
  • Amiens, France, 80054
    • CHU Amiens
  • Montpellier, France, 34295
    • CHRU Montpellier - Hopital Saint-Eloi
  • Nantes, France, 44035
    • Hotel Dieu
  • Paris, France, 75010
    • Hopital Saint Louis
  • Saint Priest en jarez, France, 42270
    • CHU Saint Etienne
  • Toulouse, France, 31082
    • Clinique Ambroise Pare
• Germany
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Hamburg, Germany, 22559
    • Asklepios Westklinikum
  • Heidelberg, Germany, 69120
    • Uniklinikum Heidelberg
  • Muenster, Germany, 48151
    • MVZ Portal10
• Hungary
  • Budapest, Hungary, 1134
    • Magyar Honvédség Egészségügyi Központ
  • Budapest, Hungary, H-1088
    • Semmelweis Egyetem
  • Békéscsaba, Hungary, H-5600
    • Réthy Pál Kórház - Rendelőintézet
  • Debrecen, Hungary, H-4032
    • Debreceni Egyetem Klinikai Kozpont
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Szombathely, Hungary, H-9700
    • Markusovszky Egyetemi Oktatokorhaz
• Italy
  • Bologna, Italy, 40138
    • Policlinico Sant'Orsola Malpighi
  • Messina, Italy, 98125
    • AOU Policlinico G.Martino
  • Milano, Italy, 20157
    • Asst Fatebenefratelli Sacco
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Palermo, Italy, 90146
    • Ospedale Villa Sofia-Cervello
  • RHO, Italy
    • Azienda Ospedaliera G.Salvini Ospedale di Rho
  • Roma, Italy, 168
    • Fondazione Policlinico Gemelli Università Cattolica
  • Roma, Italy, 00135
    • Azienda Complesso Ospedaliero San Filippo Neri
  • Roma, Italy, 00133
    • Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
  • Torino, Italy, 10128
    • AO Ordine Mauriziano
• Korea, Republic of
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Hospital
  • Gyeonggi-do, Korea, Republic of, 16247
    • The Catholic University of Korea, St. Vincent's Hospital
  • Seongnam-si, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VUMC Amsterdam
  • Arnhem, Netherlands, 6815 AD
    • Rijnstate Ziekenhuis
  • Groningen, Netherlands, 9713 GZ
    • UMCG
  • Leiden, Netherlands, 2333 ZA
    • Leiden University Medical Center
  • Nijmegen, Netherlands, 6525 GA
    • Radboudumc
  • Rotterdam, Netherlands, 3083 AN
    • Ikazia Ziekenhuis
  • Rotterdam, Netherlands, 3045 PM
    • Sint Franciscus Gasthuis
• Poland
  • Bialystok, Poland, 15-322
    • Gastromed Kralisz Romatowski Stachurska Sp. j.
  • Gdansk, Poland, 80 382
    • Synexus Polska Sp z o o
  • Krakow, Poland, 30510
    • Centrum Medyczne Pratia Poznań
  • Krakow, Poland, 30 363
    • Centrum Medyczne Plejady
  • Lodz, Poland, 90-153
    • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
  • Lublin, Poland, 20 954
    • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Oddzial Gastroenterologii
  • Rzeszow, Poland, 35-326
    • Centrum Medyczne Medyk
  • Sopot, Poland, 81 756
    • Endoskopia Sp z o o z siedziba w Sopocie
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Warszawa, Poland, 03-712
    • Gabinety Lekarskie Bodyclinic
  • Warszawa, Poland, 03 580
    • Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
  • Wroclaw, Poland, 50 449
    • Melita Medical Sp. z o.o.
  • Zamosc, Poland, 22-400
    • ETG Zamosc
• Russian Federation
  • Ekaterinburg, Russian Federation, 620109
    • OOO MO New Hospital
  • Irkutsk, Russian Federation, 664079
    • Irkutsk State Medical Academy of Postgraduate Education
  • Moscva, Russian Federation, 129090
    • GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
  • Rostov-On-Don, Russian Federation, 344022
    • Rostov State Medical University
  • Saint Petersburg, Russian Federation, 195257
    • Elizavetinskaya hospital
  • Saint Petersburg, Russian Federation, 197110
    • City Clinical Hospital #31
  • Ufa, Russian Federation, 450005
    • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
  • Ufa, Russian Federation, 450071
    • City Clinical Hospital # 21
• Serbia
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Zemun
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Zvezdara
  • Kragujevac, Serbia, 34000
    • University Clinical Center Kragujevac
  • Nis, Serbia, 18000
    • University Clinical Center Nis
  • Vojvodina, Serbia, 21000
    • Clinical Center of Vojvodina
  • Zemun, Serbia, 11080
    • Clinical Hospital Center Bezanijska Kosa
• Spain
  • Barcelona, Spain, 08025
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08003
    • Hosp. Del Mar
  • Girona, Spain, 17007
    • Hosp. Univ. Dr. Josep Trueta
  • Oviedo, Spain, 33011
    • Hosp. Univ. Central de Asturias
  • Sabadell, Spain, 08208
    • Corporacio Sanitari Parc Tauli
  • Salamanca, Spain, 37007
    • Hosp Clinico Univ de Salamanca
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Sevilla, Spain, 41009
    • Hosp. Virgen Macarena
  • Valladolid, Spain, 47012
    • Hosp. Univ. Rio Hortega
  • Zaragoza, Spain, 50009
    • Hosp. Univ. Miguel Servet
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital
  • Bury, United Kingdom, BL9 7TD
    • Pennine Acute Hospitals-Fairfield General Hospital
  • Kingston upon Thames, United Kingdom, KT2 7QB
    • Kingston Hospital
  • London, United Kingdom, SW17 0QT
    • St George's Hospital
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas' Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospitals NHS Trust
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Alabama Medical Group
  • California
    • San Diego, California, United States, 92114
      • Precision Research Institute
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Gastro Associates of Fairfield County PC
    • Danbury, Connecticut, United States, 06810
      • Western Connecticut Health Network/Danbury Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Gastro Florida
    • Gainesville, Florida, United States, 32605
      • Florida Research Network, LLC
    • Largo, Florida, United States, 33777
      • Florida Center for Gastroenterology
    • Maitland, Florida, United States, 32751
      • Center For Advanced Gastroenterology
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research Center
    • Tampa, Florida, United States, 33612
      • Apex Clinical Research
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Georgia
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Specialists, PC
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Grand Teton Research Group, PLLC
  • Kansas
    • Pratt, Kansas, United States, 67124
      • Health Science Research Center
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Tri-State Gastroenterology Assoc
    • Hazard, Kentucky, United States, 41701
      • Gastroenterology Associates Of Hazard
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Texas Digestive Disease Consultants
    • Houma, Louisiana, United States, 70360
      • CroNOLA, LLC
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Clinical Research
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Ypsilanti, Michigan, United States, 48197
      • Huron Gastroenterology Associates Center for Digestive Care
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University Hospital
    • Saint Louis, Missouri, United States, 63141
      • Mercy Clinic East Community
  • New York
    • Burnt Hills, New York, United States, 12027
      • Saratoga Schenectady Gastroenterology Associates
    • Great Neck, New York, United States, 11021
      • NYU Langone Long Island Clinical Research Associates
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10021
      • Weill Cornell Medical College
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley, PC
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Digestive Health Partners
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Raleigh, North Carolina, United States, 27609
      • Duke University Hospital Medical Center
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Gastroenterology Associates
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Fargo Gastroenterology Clinic, PC
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • NorthShore Gastroenterology Research, LLC
    • Cincinnati, Ohio, United States, 45242
      • TriHealth Digestive Institute
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University Hospital
    • Dayton, Ohio, United States, 45440
      • Dayton Gastroenterology, Inc
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists Inc
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212-4756
      • Allegheny-Singer Research Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Gastroenterology Associates P.A.
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Channelview, Texas, United States, 77530
      • Aztec Clinical Research, Inc.
    • Garland, Texas, United States, 75044
      • DHAT Research Institute
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • University of Texas at Houston Medical School
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of America, LLC
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
    • Fairfax, Virginia, United States, 22031
      • Verity Research, Inc
    • Lynchburg, Virginia, United States, 24502
      • Gastroenterology Associates of Central Virginia
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
    • Richmond, Virginia, United States, 23229
      • McGuire VAMC
    • Suffolk, Virginia, United States, 23434
      • Virginia Gastroenterology Institute
  • Washington
    • Bellevue, Washington, United States, 98004
      • Washington Gastroenterology, PLLC
    • Tacoma, Washington, United States, 98405
      • Washington Gastroenterology, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Ustekinumab); Participants 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.	Biological: Placebo for Ustekinumab; Participants will receive placebo as SC injection to blind adalimumab.; Biological: Ustekinumab (6 mg/kg); Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.; Other Names: Stelara; Biological: Ustekinumab (90 mg); Participants will self-administer SC injection of ustekinumab 90 mg.; Other Names: Stelara
Active Comparator: Group 2 (Adalimumab); Participants 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.	Biological: Placebo for Adalimumab; Participants will receive placebo as IV infusion to blind ustekinumab.; Biological: Adalimumab (40 mg); 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.; Other Names: Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 52
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.	Week 52
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.	Week 52
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.	Week 16
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.	Week 52
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.	Weeks 2, 8, 16, 24, 32, 40, 48, and 52
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.	Weeks 2, 8, 16, 24, 32, 40, 48, and 52
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.	Week 52
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.	Week 52
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.	Weeks 2, 8, 16, 24, 32, 40, 48, and 52
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.	Weeks 2, 8, 16, 24, 32, 40, 48, and 52
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.	At Weeks 8, 16 and 52
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.	Up to Week 52 and up to Week 76
Percentage of Participants With Infections	Percentage of participants with infections were reported.	Up to Week 52 and up to Week 76
Percentage of Participants With Serious Infections	Percentage of participants with serious infections were reported.	Up to Week 52 and up to Week 76
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.	Up to Week 52 and up to Week 76
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.	Up to Week 52

Collaborators and Investigators

• Sponsor: Janssen Scientific Affairs, LLC
• Investigators: Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): May 21, 2021

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Adalimumab; Ustekinumab
• Other Study ID Numbers: CR108449; 2017-004209-41 (EudraCT Number); CNTO1275CRD3007 (Other Identifier: Janssen Scientific Affairs, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No