search
Back to results

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

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo for Ustekinumab
Placebo for Adalimumab
Ustekinumab (6 mg/kg)
Ustekinumab (90 mg)
Adalimumab (40 mg)
Sponsored by
Janssen Scientific Affairs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Medical Group
  • Precision Research Institute
  • Peak Gastroenterology Associates
  • Gastro Associates of Fairfield County PC
  • Western Connecticut Health Network/Danbury Hospital
  • Medstar Washington Hospital Center
  • Gastro Florida
  • Florida Research Network, LLC
  • Florida Center For Gastroenterology
  • Center for Advanced Gastroenterology
  • Gastroenterology Group Of Naples
  • Advanced Medical Research Center
  • Apex Clinical Research
  • Cleveland Clinic Florida
  • Atlanta Gastroenterology Specialists, PC
  • Grand Teton Research Group, PLLC
  • Health Science Research Center
  • Tri-State Gastroenterology Assoc
  • Gastroenterology Associates Of Hazard
  • University of Louisville
  • Texas Digestive Disease Consultants
  • CroNOLA, LLC
  • Louisiana Research Center, LLC
  • Chevy Chase Clinical Research
  • Clinical Research Institute of Michigan, LLC
  • Huron Gastroenterology Associates Center for Digestive Care
  • Mayo Clinic
  • Saint Louis University Hospital
  • Mercy Clinic East Community
  • Saratoga Schenectady Gastroenterology Associates
  • NYU Langone Long Island Clinical Research Associates
  • Weill Cornell Medical College
  • Mount Sinai School of Medicine
  • Columbia University Medical Center
  • Premier Medical Group Of The Hudson Valley, Pc
  • University of Rochester Medical Center
  • Digestive Health Partners
  • University of North Carolina at Chapel Hill
  • Duke University Hospital Medical Center
  • Wilmington Gastroenterology Associates
  • Fargo Gastroenterology Clinic, PC
  • Northshore Gastroenterology Research, LLC
  • TriHealth Digestive Institute
  • University Hospitals Case Medical Center
  • Ohio State University Hospital
  • Dayton Gastroenterology, Inc
  • Great Lakes Gastroenterology Research, LLC
  • Digestive Disease Specialists Inc
  • Penn State Milton S. Hershey Medical Center
  • Allegheny-Singer Research Institute
  • Gastroenterology Associates P.A.
  • Vanderbilt University Medical Center
  • Aztec Clinical Research, Inc.
  • DHAT Research Institute
  • Baylor College of Medicine
  • University of Texas at Houston Medical School
  • Gastroenterology Research of America, LLC
  • Texas Digestive Disease Consultants
  • Tyler Research Institute, LLC
  • Gastroenterology Associates of Tidewater
  • Verity Research, Inc
  • Gastroenterology Associates of Central Virginia
  • Digestive And Liver Disease Specialists
  • McGuire VAMC
  • Virginia Gastroenterology Institute
  • Washington Gastroenterology, PLLC
  • Washington Gastroenterology, PLLC
  • Monash Health, Monash Medical Centre
  • Alfred Hospital
  • Mater Hospital Brisbane (Inflammatory Bowel Diseases)
  • St John of God Subiaco Hospital
  • The Queen Elizabeth Hospital
  • UZ Gent
  • UZ Leuven
  • CHwapi
  • Hospital Das Clinicas Da Ufmg
  • Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro
  • Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida
  • Hospital das Clinicas de Porto Alegre
  • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
  • Universidade Federal do Rio de Janeiro - Faculdade de Medicina
  • Hospital Copa D'Or
  • Fundacao do ABC - Centro Universitario FMABC
  • UMHAT 'Dr. Georgi Stranski', EAD
  • MHAT Rousse
  • 2-nd MHAT
  • Diagnostic Consulting Center Mladost - M Varna
  • University of Calgary
  • McMaster University
  • London Health Sciences Centre
  • CISSS de la Monteregie Centre
  • CMIIM, Centre médical L'Enjeu
  • Fakultní nemocnice u sv. Anny v Brn
  • Nemocnice Horovice, a.s.
  • Hepato-gastroenterologie HK, s.r.o.
  • Fakultni nemocnice Kralovske Vinohrady
  • ISCARE a.s.
  • CHU Amiens
  • CHRU Montpellier - Hopital Saint-Eloi
  • Hotel Dieu
  • Hopital Saint-Louis
  • CHU Saint-etienne
  • Clinique Ambroise Pare
  • Universitatsklinikum Freiburg
  • Asklepios Westklinikum
  • Uniklinikum Heidelberg
  • MVZ Portal10
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Semmelweis Egyetem
  • Réthy Pál Kórház - Rendelőintézet
  • Debreceni Egyetem Klinikai Kozpont
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Markusovszky Egyetemi Oktatokorhaz
  • Policlinico Sant'Orsola Malpighi
  • AOU Policlinico G.Martino
  • ASST Fatebenefratelli Sacco
  • Azienda Ospedaliera di Padova
  • Ospedale Villa Sofia-Cervello
  • Azienda Ospedaliera G.Salvini Ospedale di Rho
  • Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
  • Azienda Complesso Ospedaliero San Filippo Neri
  • Fondazione Policlinico Gemelli Università Cattolica
  • Istituto Clinico Humanitas
  • AO Ordine Mauriziano
  • Yeungnam University Hospital
  • The Catholic university of Korea, St. Vincent's Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Severance Hospital, Yonsei University Health System
  • VUMC Amsterdam
  • Rijnstate Ziekenhuis
  • UMCG
  • Leiden University Medical Center
  • Radboudumc
  • Sint Franciscus Gasthuis
  • Ikazia Ziekenhuis
  • Gastromed Kralisz Romatowski Stachurska Sp. j.
  • Synexus Polska Sp. z o.o.
  • Centrum Medyczne Plejady
  • Centrum Medyczne Pratia Poznan
  • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Oddział Gastroenterologii
  • Centrum Medyczne Medyk
  • Endoskopia Sp. z o.o. z siedzibą w Sopocie
  • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
  • Gabinety Lekarskie Bodyclinic
  • Melita Medical Sp. z o.o.
  • ETG Zamosc
  • OOO MO New Hospital
  • Irkutsk State Medical Academy of Postgraduate Education
  • GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
  • Rostov State Medical University
  • Elizavetinskaya hospital
  • City Clinical Hospital #31
  • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
  • City Clinical Hospital # 21
  • Clinical Hospital Center Zemun
  • Clinical Hospital Center Zvezdara
  • University Clinical Center Kragujevac
  • University Clinical Center NIS
  • Clinical Center of Vojvodina
  • Clinical Hospital Center Bezanijska Kosa
  • Hosp. Del Mar
  • Hosp. de La Santa Creu I Sant Pau
  • Hosp. Univ. Dr. Josep Trueta
  • Hosp. Univ. Central de Asturias
  • Corporacio Sanitari Parc Tauli
  • Hosp. Clinico Univ. de Salamanca
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Virgen Macarena
  • Hosp. Univ. Rio Hortega
  • Hosp. Univ. Miguel Servet
  • Royal United Hospital
  • Pennine Acute Hospitals-Fairfield General Hospital
  • Kingston Hospital
  • Guy's and St Thomas' Hospital
  • St George's Hospital
  • Southampton University Hospitals NHS Trust
  • Musgrove Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1 (Ustekinumab)

Group 2 (Adalimumab)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Percentage of Participants With Infections
Percentage of participants with infections were reported.
Percentage of Participants With Serious Infections
Percentage of participants with serious infections were reported.
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.
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.

Full Information

First Posted
March 7, 2018
Last Updated
June 1, 2023
Sponsor
Janssen Scientific Affairs, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03464136
Brief Title
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
Acronym
SEAVUE
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
May 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Ustekinumab)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 (Adalimumab)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo for Ustekinumab
Intervention Description
Participants will receive placebo as SC injection to blind adalimumab.
Intervention Type
Biological
Intervention Name(s)
Placebo for Adalimumab
Intervention Description
Participants will receive placebo as IV infusion to blind ustekinumab.
Intervention Type
Biological
Intervention Name(s)
Ustekinumab (6 mg/kg)
Other Intervention Name(s)
Stelara
Intervention Description
Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.
Intervention Type
Biological
Intervention Name(s)
Ustekinumab (90 mg)
Other Intervention Name(s)
Stelara
Intervention Description
Participants will self-administer SC injection of ustekinumab 90 mg.
Intervention Type
Biological
Intervention Name(s)
Adalimumab (40 mg)
Other Intervention Name(s)
Humira
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission at Week 52
Description
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.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants With Corticosteroid-free Remission at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants With Clinical Response at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants With Clinical Remission at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants With Endoscopic Remission at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants With Clinical Remission Through Week 52
Description
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.
Time Frame
Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Title
Percentage of Participants With Clinical Response Through Week 52
Description
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.
Time Frame
Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Title
Percentage of Participants With Durable Clinical Response at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants With Durable Clinical Remission at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants With Abdominal Pain (AP) Improvement Through Week 52
Description
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.
Time Frame
Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Title
Percentage of Participants With Reduction in Frequency of Diarrhea Through Week 52
Description
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.
Time Frame
Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Title
Percentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52
Description
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.
Time Frame
At Weeks 8, 16 and 52
Title
Percentage of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to Week 52 and up to Week 76
Title
Percentage of Participants With Infections
Description
Percentage of participants with infections were reported.
Time Frame
Up to Week 52 and up to Week 76
Title
Percentage of Participants With Serious Infections
Description
Percentage of participants with serious infections were reported.
Time Frame
Up to Week 52 and up to Week 76
Title
Percentage of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Week 52 and up to Week 76
Title
Percentage of Participants With Anti-drug Antibodies
Description
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.
Time Frame
Up to Week 52

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35691323
Citation
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.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

We'll reach out to this number within 24 hrs