MedPath

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

Phase 3
Completed
Conditions
Crohn Disease
Interventions
Biological: Ustekinumab (6 mg/kg)
Biological: Adalimumab (40 mg)
Biological: Ustekinumab (90 mg)
Registration Number
NCT03464136
Lead Sponsor
Janssen Scientific Affairs, LLC
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
386
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 2 (Adalimumab)Placebo for AdalimumabParticipants 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.
Group 1 (Ustekinumab)Ustekinumab (6 mg/kg)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.
Group 2 (Adalimumab)Adalimumab (40 mg)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.
Group 1 (Ustekinumab)Ustekinumab (90 mg)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.
Group 1 (Ustekinumab)Placebo for UstekinumabParticipants 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.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Clinical Remission at Week 52Week 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
NameTimeMethod
Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52Week 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 Response Through Week 52Weeks 2, 8, 16, 24, 32, 40, 48, and 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 Clinical Remission Through Week 52Weeks 2, 8, 16, 24, 32, 40, 48, and 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 Serious Adverse Events (SAEs)Up to Week 52 and up to Week 76

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 Clinical Response at Week 52Week 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 With Adverse Events (AEs)Up to Week 52 and up to Week 76

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 Corticosteroid-free Remission at Week 52Week 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 Endoscopic Remission at Week 52Week 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 Durable Clinical Remission at Week 52Week 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 52Weeks 2, 8, 16, 24, 32, 40, 48, and 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 Clinical and Biomarker Remission at Weeks 8, 16 and 52At 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 InfectionsUp to Week 52 and up to Week 76

Percentage of participants with infections were reported.

Percentage of Participants With Anti-drug AntibodiesUp to Week 52

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.

Percentage of Participants With Clinical Remission at Week 16Week 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 Durable Clinical Response at Week 52Week 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 Reduction in Frequency of Diarrhea Through Week 52Weeks 2, 8, 16, 24, 32, 40, 48, and 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 Serious InfectionsUp to Week 52 and up to Week 76

Percentage of participants with serious infections were reported.

Trial Locations

Locations (180)

2-nd MHAT

🇧🇬

Sofia, Bulgaria

CISSS de la Monteregie Centre

🇨🇦

Greenfield Park, Quebec, Canada

CMIIM, Centre médical L'Enjeu

🇨🇦

Mont-Royal, Quebec, Canada

Fakultní nemocnice u sv. Anny v Brn

🇨🇿

Brno, Czechia

Diagnostic Consulting Center Mladost - M Varna

🇧🇬

Varna, Bulgaria

University of Calgary

🇨🇦

Calgary, Alberta, Canada

McMaster University

🇨🇦

Hamilton, Ontario, Canada

London Health Sciences Centre

🇨🇦

London, Ontario, Canada

Nemocnice Horovice, a.s.

🇨🇿

Horovice, Czechia

CHU Amiens

🇫🇷

Amiens, France

CHU Saint Etienne

🇫🇷

Saint Priest en jarez, France

Hepato-gastroenterologie HK, s.r.o.

🇨🇿

Hradec Kralove, Czechia

Fakultni nemocnice Kralovske Vinohrady

🇨🇿

Praha 10, Czechia

ISCARE a.s.

🇨🇿

Praha 9, Czechia

CHRU Montpellier - Hopital Saint-Eloi

🇫🇷

Montpellier, France

Hotel Dieu

🇫🇷

Nantes, France

Alabama Medical Group

🇺🇸

Mobile, Alabama, United States

Peak Gastroenterology Associates

🇺🇸

Colorado Springs, Colorado, United States

Precision Research Institute

🇺🇸

San Diego, California, United States

Gastro Associates of Fairfield County PC

🇺🇸

Bridgeport, Connecticut, United States

Western Connecticut Health Network/Danbury Hospital

🇺🇸

Danbury, Connecticut, United States

Gastro Florida

🇺🇸

Clearwater, Florida, United States

Florida Research Network, LLC

🇺🇸

Gainesville, Florida, United States

Gastroenterology Group Of Naples

🇺🇸

Naples, Florida, United States

Advanced Medical Research Center

🇺🇸

Port Orange, Florida, United States

Medstar Washington Hospital Center

🇺🇸

Washington, District of Columbia, United States

Grand Teton Research Group, PLLC

🇺🇸

Idaho Falls, Idaho, United States

Clinical Research Institute of Michigan, LLC

🇺🇸

Chesterfield, Michigan, United States

Center for Advanced Gastroenterology

🇺🇸

Maitland, Florida, United States

Florida Center For Gastroenterology

🇺🇸

Largo, Florida, United States

Apex Clinical Research

🇺🇸

Tampa, Florida, United States

Cleveland Clinic Florida

🇺🇸

Weston, Florida, United States

Atlanta Gastroenterology Specialists, PC

🇺🇸

Suwanee, Georgia, United States

Health Science Research Center

🇺🇸

Pratt, Kansas, United States

Tri-State Gastroenterology Assoc

🇺🇸

Crestview Hills, Kentucky, United States

Huron Gastroenterology Associates Center for Digestive Care

🇺🇸

Ypsilanti, Michigan, United States

Gastroenterology Associates Of Hazard

🇺🇸

Hazard, Kentucky, United States

Mercy Clinic East Community

🇺🇸

Saint Louis, Missouri, United States

Columbia University Medical Center

🇺🇸

New York, New York, United States

Dayton Gastroenterology, Inc

🇺🇸

Dayton, Ohio, United States

Baylor College of Medicine

🇺🇸

Houston, Texas, United States

Gastroenterology Research of America, LLC

🇺🇸

San Antonio, Texas, United States

Tyler Research Institute, LLC

🇺🇸

Tyler, Texas, United States

Gastroenterology Associates of Tidewater

🇺🇸

Chesapeake, Virginia, United States

University of Louisville

🇺🇸

Louisville, Kentucky, United States

CroNOLA, LLC

🇺🇸

Houma, Louisiana, United States

Texas Digestive Disease Consultants

🇺🇸

Southlake, Texas, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Louisiana Research Center, LLC

🇺🇸

Shreveport, Louisiana, United States

Chevy Chase Clinical Research

🇺🇸

Chevy Chase, Maryland, United States

Saint Louis University Hospital

🇺🇸

Saint Louis, Missouri, United States

NYU Langone Long Island Clinical Research Associates

🇺🇸

Great Neck, New York, United States

Premier Medical Group Of The Hudson Valley, Pc

🇺🇸

Poughkeepsie, New York, United States

Digestive Health Partners

🇺🇸

Asheville, North Carolina, United States

University of North Carolina at Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

Ohio State University Hospital

🇺🇸

Columbus, Ohio, United States

Saratoga Schenectady Gastroenterology Associates

🇺🇸

Burnt Hills, New York, United States

Mount Sinai School of Medicine

🇺🇸

New York, New York, United States

University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

Weill Cornell Medical College

🇺🇸

New York, New York, United States

Duke University Hospital Medical Center

🇺🇸

Raleigh, North Carolina, United States

Wilmington Gastroenterology Associates

🇺🇸

Wilmington, North Carolina, United States

Penn State Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Gastroenterology Associates P.A.

🇺🇸

Greenville, South Carolina, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

University Hospitals Case Medical Center

🇺🇸

Cleveland, Ohio, United States

Great Lakes Gastroenterology Research, LLC

🇺🇸

Mentor, Ohio, United States

Fargo Gastroenterology Clinic, PC

🇺🇸

Fargo, North Dakota, United States

Northshore Gastroenterology Research, LLC

🇺🇸

Beachwood, Ohio, United States

TriHealth Digestive Institute

🇺🇸

Cincinnati, Ohio, United States

Allegheny-Singer Research Institute

🇺🇸

Pittsburgh, Pennsylvania, United States

Digestive Disease Specialists Inc

🇺🇸

Oklahoma City, Oklahoma, United States

DHAT Research Institute

🇺🇸

Garland, Texas, United States

Gastroenterology Associates of Central Virginia

🇺🇸

Lynchburg, Virginia, United States

University of Texas at Houston Medical School

🇺🇸

Houston, Texas, United States

McGuire VAMC

🇺🇸

Richmond, Virginia, United States

Aztec Clinical Research, Inc.

🇺🇸

Channelview, Texas, United States

Verity Research, Inc

🇺🇸

Fairfax, Virginia, United States

Digestive And Liver Disease Specialists

🇺🇸

Norfolk, Virginia, United States

Virginia Gastroenterology Institute

🇺🇸

Suffolk, Virginia, United States

MHAT Rousse

🇧🇬

Rousse, Bulgaria

Mater Hospital Brisbane Inflammatory Bowel Diseases

🇦🇺

South Brisbane, Australia

Washington Gastroenterology, PLLC

🇺🇸

Tacoma, Washington, United States

Monash Health, Monash Medical Centre

🇦🇺

Clayton, Australia

Alfred Hospital

🇦🇺

Melbourne, Australia

UZ Gent

🇧🇪

Gent, Belgium

St John of God Subiaco Hospital

🇦🇺

Subiaco, Australia

The Queen Elizabeth Hospital

🇦🇺

Woodville South, Australia

UZ Leuven

🇧🇪

Leuven, Belgium

Hospital Das Clinicas Da Ufmg

🇧🇷

Belo Horizonte - MG, Brazil

CHwapi

🇧🇪

Tournai, Belgium

Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro

🇧🇷

Goiania, Brazil

Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida

🇧🇷

Juiz de Fora, Brazil

Hospital das Clinicas de Porto Alegre

🇧🇷

Porto Alegre, Brazil

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

🇧🇷

Ribeirao Preto, Brazil

UMHAT 'Dr. Georgi Stranski', EAD

🇧🇬

Pleven, Bulgaria

Universidade Federal do Rio de Janeiro - Faculdade de Medicina

🇧🇷

Rio de Janeiro, Brazil

Hospital Copa D'Or

🇧🇷

Rio de Janeiro, Brazil

Fundacao do ABC Centro Universitario FMABC

🇧🇷

Santo Andre, Brazil

Hopital Saint Louis

🇫🇷

Paris, France

Clinique Ambroise Pare

🇫🇷

Toulouse, France

Uniklinikum Heidelberg

🇩🇪

Heidelberg, Germany

Réthy Pál Kórház - Rendelőintézet

🇭🇺

Békéscsaba, Hungary

Universitatsklinikum Freiburg

🇩🇪

Freiburg, Germany

AOU Policlinico G.Martino

🇮🇹

Messina, Italy

Asklepios Westklinikum

🇩🇪

Hamburg, Germany

MVZ Portal10

🇩🇪

Muenster, Germany

Magyar Honvedseg Egeszsegugyi Kozpont

🇭🇺

Budapest, Hungary

Semmelweis Egyetem

🇭🇺

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

🇭🇺

Debrecen, Hungary

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

🇭🇺

Miskolc, Hungary

Markusovszky Egyetemi Oktatokorhaz

🇭🇺

Szombathely, Hungary

Policlinico Sant'Orsola Malpighi

🇮🇹

Bologna, Italy

ASST Fatebenefratelli Sacco

🇮🇹

Milano, Italy

Azienda Ospedaliera di Padova

🇮🇹

Padova, Italy

Ospedale Villa Sofia-Cervello

🇮🇹

Palermo, Italy

Azienda Ospedaliera G.Salvini Ospedale di Rho

🇮🇹

RHO, Italy

Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

🇮🇹

Roma, Italy

Azienda Complesso Ospedaliero San Filippo Neri

🇮🇹

Roma, Italy

Fondazione Policlinico Gemelli Università Cattolica

🇮🇹

Roma, Italy

Istituto Clinico Humanitas

🇮🇹

Rozzano, Italy

AO Ordine Mauriziano

🇮🇹

Torino, Italy

Yeungnam University Hospital

🇰🇷

Daegu, Korea, Republic of

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

🇰🇷

Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital

🇰🇷

Seongnam-si, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Severance Hospital Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

VUMC Amsterdam

🇳🇱

Amsterdam, Netherlands

Rijnstate Ziekenhuis

🇳🇱

Arnhem, Netherlands

UMCG

🇳🇱

Groningen, Netherlands

Leiden University Medical Center

🇳🇱

Leiden, Netherlands

Radboudumc

🇳🇱

Nijmegen, Netherlands

Sint Franciscus Gasthuis

🇳🇱

Rotterdam, Netherlands

Ikazia Ziekenhuis

🇳🇱

Rotterdam, Netherlands

Gastromed Kralisz Romatowski Stachurska Sp. j.

🇵🇱

Bialystok, Poland

Centrum Medyczne Pratia Poznan

🇵🇱

Krakow, Poland

Synexus Polska Sp z o o

🇵🇱

Gdansk, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Oddzial Gastroenterologii

🇵🇱

Lublin, Poland

Centrum Medyczne Plejady

🇵🇱

Krakow, Poland

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

🇵🇱

Lodz, Poland

Centrum Medyczne Medyk

🇵🇱

Rzeszow, Poland

Melita Medical Sp. z o.o.

🇵🇱

Wroclaw, Poland

Rostov State Medical University

🇷🇺

Rostov-On-Don, Russian Federation

Endoskopia Sp z o o z siedziba w Sopocie

🇵🇱

Sopot, Poland

Centralny Szpital Kliniczny MSWiA w Warszawie

🇵🇱

Warsaw, Poland

Gabinety Lekarskie Bodyclinic

🇵🇱

Warszawa, Poland

Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz

🇵🇱

Warszawa, Poland

ETG Zamosc

🇵🇱

Zamosc, Poland

OOO MO New Hospital

🇷🇺

Ekaterinburg, Russian Federation

Irkutsk State Medical Academy of Postgraduate Education

🇷🇺

Irkutsk, Russian Federation

Clinical Hospital Center Zemun

🇷🇸

Belgrade, Serbia

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

🇷🇺

Moscva, Russian Federation

Elizavetinskaya hospital

🇷🇺

Saint Petersburg, Russian Federation

City Clinical Hospital #31

🇷🇺

Saint Petersburg, Russian Federation

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

🇷🇺

Ufa, Russian Federation

City Clinical Hospital # 21

🇷🇺

Ufa, Russian Federation

Clinical Hospital Center Zvezdara

🇷🇸

Belgrade, Serbia

University Clinical Center Kragujevac

🇷🇸

Kragujevac, Serbia

Clinical Center of Vojvodina

🇷🇸

Vojvodina, Serbia

University Clinical Center NIS

🇷🇸

Nis, Serbia

Clinical Hospital Center Bezanijska Kosa

🇷🇸

Zemun, Serbia

Hosp. Del Mar

🇪🇸

Barcelona, Spain

Corporacio Sanitari Parc Tauli

🇪🇸

Sabadell, Spain

Hosp. de La Santa Creu I Sant Pau

🇪🇸

Barcelona, Spain

Hosp. Univ. Dr. Josep Trueta

🇪🇸

Girona, Spain

Hosp. Univ. Central de Asturias

🇪🇸

Oviedo, Spain

Hosp Clinico Univ de Salamanca

🇪🇸

Salamanca, Spain

Hosp. Univ. Marques de Valdecilla

🇪🇸

Santander, Spain

Hosp. Virgen Macarena

🇪🇸

Sevilla, Spain

Hosp. Univ. Miguel Servet

🇪🇸

Zaragoza, Spain

Royal United Hospital

🇬🇧

Bath, United Kingdom

Hosp. Univ. Rio Hortega

🇪🇸

Valladolid, Spain

Pennine Acute Hospitals-Fairfield General Hospital

🇬🇧

Bury, United Kingdom

Kingston Hospital

🇬🇧

Kingston upon Thames, United Kingdom

Guy's and St Thomas' Hospital

🇬🇧

London, United Kingdom

St George's Hospital

🇬🇧

London, United Kingdom

Southampton University Hospitals NHS Trust

🇬🇧

Southampton, United Kingdom

Musgrove Park Hospital

🇬🇧

Taunton, United Kingdom

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