An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
- Conditions
- Colitis, Ulcerative
- Interventions
- Registration Number
- NCT02497469
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
- Detailed Description
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.
The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* Vedolizumab 300 mg IV
* Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC
All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 771
-
Has a diagnosis of ulcerative colitis established at least 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
-
Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.
-
Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
-
With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).
-
The participant:
- Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha) antagonists without documented clinical response to treatment (example, due to lack of response [primary nonresponders], loss of response, or intolerance [secondary nonresponders]), or
- Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued its use due to reasons other than safety, or
- Is naïve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).
-
Clinical evidence of abdominal abscess or toxic megacolon at Screening.
-
Has had an extensive colonic resection, subtotal or total colectomy.
-
Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
-
Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
-
Has received any of the following for the treatment of underlying disease within 30 days of randomization:
- Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in Section Permitted Medications For Treatment of UC.
- An approved non-biologic therapy in an investigational protocol.
-
Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
-
Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 antibodies, or rituximab.
-
Has previously received vedolizumab.
-
Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
-
Evidence of an active infection during Screening.
-
Evidence of, or treatment for, Clostridium difficile (C. difficile) or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
-
Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection (* HBV immune participants, ie, being hepatitis B surface antigen [HBsAg], may participate).
-
Has active or latent TB, regardless of treatment history.
-
Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.
-
Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adalimumab SC 160/80/40 mg Vedolizumab placebo Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Vedolizumab IV 300 mg Adalimumab placebo Vedolizumab 300 milligram (mg), infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50. Vedolizumab IV 300 mg Vedolizumab Vedolizumab 300 milligram (mg), infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50. Adalimumab SC 160/80/40 mg Adalimumab Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Clinical Remission Week 52 Clinical remission was defined as a complete Mayo score of ≤2 points and no individual subscore \>1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Mucosal Healing Week 52 Mucosal healing was defined as a Mayo score endoscopic subscore of \<= 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission Week 52 Corticosteroid-free remission was defined as participants using oral corticosteroids at Baseline (Week 0) who had discontinued oral corticosteroids and were in clinical remission at Week 52. Clinical remission was defined as a complete Mayo score of ≤ 2 points and no individual subscore \> 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Trial Locations
- Locations (329)
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Texas Digestive Disease Consultants - Dallas
🇺🇸Dallas, Texas, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Virginia Mason Seattle Main Clinic
🇺🇸Seattle, Washington, United States
Tellus Clinical Research, Inc.
🇺🇸Miami, Florida, United States
IMC - Diagnostic and Medical Clinic
🇺🇸Mobile, Alabama, United States
California Medical Research Associates Inc.
🇺🇸Northridge, California, United States
WCCT Global (PH 1 Unit)
🇺🇸Costa Mesa, California, United States
Rocky Mountain Gastroenterology
🇺🇸Lakewood, Colorado, United States
Advanced Clinical Research of Miami
🇺🇸Doral, Florida, United States
Innovative Medical Research of South Florida, Inc.
🇺🇸Aventura, Florida, United States
Wellness Clinical Research
🇺🇸Hialeah Gardens, Florida, United States
Nature Coast Clinical Research, LLC
🇺🇸Inverness, Florida, United States
Gastro Health
🇺🇸Miami, Florida, United States
Florida Center for Gastroenterology
🇺🇸Largo, Florida, United States
South Florida Research Phase I-IV
🇺🇸Miami Springs, Florida, United States
Medical Professional Clinical Research
🇺🇸Miami, Florida, United States
BRCR Medical Center, Inc.
🇺🇸Plantation, Florida, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Gastroenterology of Southern Associates
🇺🇸New Albany, Indiana, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Research Concierge, LLC
🇺🇸Owensboro, Kentucky, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Digestive Disease Associates
🇺🇸Catonsville, Maryland, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Center for Digestive Health and Nutritional Excellence
🇺🇸Troy, Michigan, United States
Gastroenterology Associates of Western Michigan, P.L.C.
🇺🇸Wyoming, Michigan, United States
Ehrhardt Clinical Research, LLC
🇺🇸Belton, Missouri, United States
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
AGA Clinical Research Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
Premier Medical Group of the Hudson Valley, PC
🇺🇸Poughkeepsie, New York, United States
Mount Sinai - PRIME
🇺🇸Lake Success, New York, United States
Ohio State University Clinical Trials Management Office
🇺🇸Columbus, Ohio, United States
Dayton Gastroenterology, Inc
🇺🇸Dayton, Ohio, United States
Gastro-Enterology Research of Lima
🇺🇸Lima, Ohio, United States
Options Health Research
🇺🇸Tulsa, Oklahoma, United States
The Oregon Clinic-West Hills Gastroenterology
🇺🇸Portland, Oregon, United States
Main Line Gastroenterology Associates
🇺🇸Malvern, Pennsylvania, United States
Baylor University Hospital
🇺🇸Dallas, Texas, United States
MedResearch, Inc
🇺🇸El Paso, Texas, United States
Gulf Coast Research Group LLC
🇺🇸Houston, Texas, United States
Gastroenterology Consultants of South Texas, PA
🇺🇸Harlingen, Texas, United States
Advanced Clinical Research Associates
🇺🇸Plano, Texas, United States
Texas Digestive Disease Consultants - Irving
🇺🇸Irving, Texas, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
Texas Digestive Disease Consultants - Southlake
🇺🇸Southlake, Texas, United States
Digestive Health Specialists of Tyler
🇺🇸Tyler, Texas, United States
Wenatchee Valley Hospital & Clinics
🇺🇸Wenatchee, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Centro de Investigaciones Clinicas Instituto del Corazon
🇦🇷Cordoba, Argentina
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Tennyson Centre Day Hospital
🇦🇺Bedford Park, South Australia, Australia
Ballarat Base Hospital
🇦🇺Ballarat, Victoria, Australia
MHAT - Pazardzhik AD
🇧🇬Pazardzhik, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
🇧🇬Sofia, Bulgaria
Medical Center "Excelsior", OOD
🇧🇬Sofia, Bulgaria
UMHAT 'Sveta Anna' AD
🇧🇬Sofia, Bulgaria
McMaster University Health Sciences Center
🇨🇦Hamilton, Ontario, Canada
Hotel Dieu Hospital
🇨🇦Kingston, Ontario, Canada
LHSC - University Hospital
🇨🇦London, Ontario, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Toronto Digestive Disease Associates, Inc.
🇨🇦Vaughan, Ontario, Canada
Fundacion Oftalmologica de Santander - FOSCAL
🇨🇴Floridablanca, Colombia
General Hospital Pula
ðŸ‡ðŸ‡·Pula, Croatia
Clinical Hospital Dubrava
ðŸ‡ðŸ‡·Zagreb, Croatia
CCBR - Brno - CZ
🇨🇿Brno, Czechia
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
A-Shine
🇨🇿Plzen, Czechia
CCBR Czech, a.s
🇨🇿Pardubice, Czechia
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
CCBR - Prague - CZ
🇨🇿Praha 3, Czechia
Thomayerova nemocnice
🇨🇿Praha 4 - Krc, Czechia
Klinicke centrum ISCARE Lighthouse
🇨🇿Praha 7, Czechia
Odense Universitetshospital
🇩🇰Odense C, Denmark
Axon Clinical, s.r.o.
🇨🇿Praha 8, Czechia
North Estonia Medical Centre Foundation
🇪🇪Tallinn, Estonia
Tartu University Hospital
🇪🇪Tartu, Estonia
CHU Nice - Hopital de l'Archet 2
🇫🇷Nice Cedex 3, Alpes Maritimes, France
Hopital Beaujon
🇫🇷Clichy cedex, Hauts De Seine, France
Groupe Hospitalier Sud - Hopital Haut-Leveque
🇫🇷Pessac, Gironde, France
CHU de Toulouse - Hopital Rangueil
🇫🇷Toulouse Cedex 09, Haute Garonne, France
Centre Hospitalier Departemental Les Oudairies
🇫🇷La Roche S/ Yon Cedex 9, Vendee, France
Hopital de Brabois Adultes
🇫🇷Vandoeuvre les Nancy, Meurthe Et Moselle, France
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Baden Wuerttemberg, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Hessen, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Baden Wuerttemberg, Germany
Universitaetsklinikum Koeln
🇩🇪Koeln, Nordrhein Westfalen, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
🇩🇪Mainz, Rheinland Pfalz, Germany
Universitaetsklinikum Magdeburg A.oe.R
🇩🇪Magdeburg, Sachsen Anhalt, Germany
EUGASTRO GmbH
🇩🇪Leipzig, Sachsen, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
🇩🇪Kiel, Schleswig Holstein, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
🇩🇪Lubeck, Schleswig Holstein, Germany
Charite - Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Krankenhaus Waldfriede e. V.
🇩🇪Berlin, Germany
Asklepios Klinik Hamburg
🇩🇪Hamburg, Germany
The Chinese University of Hong Kong
ðŸ‡ðŸ‡°Shatin, Hong Kong
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
ðŸ‡ðŸ‡ºBekescsaba, Hungary
Pannonia Maganorvosi Centrum
ðŸ‡ðŸ‡ºBudapest, Hungary
Debreceni Egyetem Klinikai Kozpont
ðŸ‡ðŸ‡ºDebrecen, Hungary
HaEmek Medical Center
🇮🇱Afula, Israel
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Galilee Medical Center
🇮🇱Nahariya, Israel
Kaplan Medical Center
🇮🇱Rechovot, Israel
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
I.R.C.C.S Policlinico San Donato
🇮🇹San Donato Milanese, Milano, Italy
Azienda Ospedaliera Ospedale Cannizzaro
🇮🇹Catania, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliero Universitaria San Martino
🇮🇹Genova, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
🇮🇹Messina, Italy
Azienda Ospedaliera Universitaria "Federico II"
🇮🇹Napoli, Italy
A.O.U. Policlinico di Modena
🇮🇹Modena, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Seconda Universita degli Studi di Napoli
🇮🇹Napoli, Italy
Azienda Ospedaliera Vincenzo Cervello
🇮🇹Palermo, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Hanyang Univerisy Guri Hospital
🇰🇷Guri-si, Gyeonggi-do, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Gyeongsangbuk-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Digestive Diseases Center "Gastro"
🇱🇻Riga, Latvia
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Pauls Stradins Clinical University Hospital SLLC
🇱🇻Riga, Latvia
Vilnius University Hospital Santariskiu Clinic, Public Institution
🇱🇹Vilnius, Lithuania
Sociedad de Metabolismo y Corazon S.C
🇲🇽Veracruz, Mexico
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
🇵🇱Bialystok, Poland
Gabinet Endoskopii Przewodu Pokarmowego
🇵🇱Krakow, Poland
SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
🇵🇱Lodz, Poland
GASTROMED Sp. z o.o.
🇵🇱Lublin, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
🇵🇱Warszawa, Poland
SOLUMED Centrum Medyczne
🇵🇱Poznan, Poland
Centralny Szpital Kliniczny MSW w Warszawie
🇵🇱Warszawa, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
🇵🇱Warszawa, Poland
EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu
🇵🇱Wroclaw, Poland
Nzoz Vivamed
🇵🇱Warszawa, Poland
LexMedica Osrodek Badan Klinicznych
🇵🇱Wroclaw, Poland
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
🇵🇱Wroclaw, Poland
Centro Hospitalar Cova da Beira
🇵🇹Covilha, Portugal
Centro Hospitalar e Universitario de Coimbra E.P.E
🇵🇹Coimbra, Portugal
Hospital de Braga
🇵🇹Braga, Portugal
Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE
🇵🇹Viana do Castelo, Portugal
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
🇷🇴Timisoara, Romania
TSBIH "Territorial Clinical Hospital"
🇷🇺Krasnoyarsk, Russian Federation
Research Institute of Gastroenterology
🇷🇺Moscow, Russian Federation
BHI of Omsk region Clinical Oncology Dispensary
🇷🇺Omsk, Russian Federation
SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
🇷🇺Omsk, Russian Federation
SBEI HPE "Rostov State Medical University" of the MoH of the RF
🇷🇺Rostov-on-Don, Russian Federation
FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
🇷🇺Saint-Petersburg, Russian Federation
SPb SBIH "City Hospital # 9"
🇷🇺Saint-Petersburg, Russian Federation
SIH "Regional Clinical Hospital "
🇷🇺Saratov, Russian Federation
RSBIH "Smolensk Regional Clinical Hospital"
🇷🇺Smolensk, Russian Federation
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
SPb SBIH "City Hospital of Saint Martyr Elizaveta"
🇷🇺St. Petersburg, Russian Federation
Clinical Center Zvezdara
🇷🇸Belgrade, Serbia
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
Frantisek Horvath- GEA
🇸🇰Sahy, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
🇸🇰Bratislava, Slovakia
KM Management spol. s r.o.
🇸🇰Nitra, Slovakia
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Gastroped s.r.o.
🇸🇰Kosice, Slovakia
Gastro I, s.r.o.
🇸🇰Presov, Slovakia
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Kocaeli Derince Training and Research Hospital
🇹🇷Kocaeli, Turkey
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Haydarpasa Numune Training and Research Hospital
🇹🇷Istanbul, Turkey
Acibadem Fulya Hospital
🇹🇷Istanbul, Turkey
Marmara University Pendik Research and Training Hospital
🇹🇷Istanbul, Turkey
Mersin University Medical Faculty
🇹🇷Mersin, Turkey
RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
🇺🇦Chernivtsi, Ukraine
Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
🇺🇦Ivano-Frankivsk, Ukraine
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
🇺🇦Kirovohrad, Ukraine
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
🇺🇦Kyiv, Ukraine
CI of TRC Ternopil University Hospital
🇺🇦Lviv, Ukraine
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
🇺🇦Uzhgorod, Ukraine
Private Small Enterprise Medical Center Pulse
🇺🇦Vinnytsia, Ukraine
Salford Royal
🇬🇧Salford, Greater Manchester, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, Norfolk, United Kingdom
University Hospital Coventry
🇬🇧Coventry, West Midlands, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, Strathclyde, United Kingdom
Royal Wolverhampton hospital
🇬🇧Wolverhampton, West Midlands, United Kingdom
Morales Vargas Centro de Investigacion, S.C.
🇲🇽Leon, Guanajuato, Mexico
Centro de Investigacion Farmacologica del Bajio, S.C.
🇲🇽Leon, Guanajuato, Mexico
Cotton-O'Neil Clinical Research Center, Digestive Health
🇺🇸Topeka, Kansas, United States
Consultants for Clinical Research Inc.
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Gastroenterology Research of San Antonio, LLC
🇺🇸San Antonio, Texas, United States
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Arkansas Primary Care Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Digestive Health Center PA
🇺🇸Ocean Springs, Mississippi, United States
Lafayette General Medical Center
🇺🇸Lafayette, Louisiana, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Instituto Medico CER
🇦🇷Quilmes, Buenos Aires, Argentina
Expertia S.A- Mautalen Salud e Investigacion
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
University Clinical Hospital Mostar
🇧🇦Mostar, Bosnia and Herzegovina
University Clinic Centre Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
St Frances Xavier Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
University Clinical Centre of the Republic of Srpska
🇧🇦Banja Luka, Bosnia and Herzegovina
Onze Lieve Vrouwe Gasthuis, Locatie Oost
🇳🇱Amsterdam, Netherlands
Santa Familia Centrum Badan, Profilaktyki i Leczenia
🇵🇱Lodz, Poland
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
MHAT 'Sv. Marina', EAD
🇧🇬Varna, Bulgaria
FSBI State Scientific Centre of Coloproctology" of the MoH of RF
🇷🇺Moscow, Russian Federation
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Invocare Clinical Research Center
🇺🇸West Columbia, South Carolina, United States
Instituto de Investigaciones Clinicas-Mar del Plata
🇦🇷Mar del Plata, Buenos Aires, Argentina
MHAT 'Avis Medica' OOD
🇧🇬Pleven, Bulgaria
MHAT "Hadzhi Dimitar", OOD
🇧🇬Sliven, Bulgaria
"City Clinic UMHAC" EOOD
🇧🇬Sofia, Bulgaria
Military Medical Academy - MHAT - Sofia
🇧🇬Sofia, Bulgaria
Clinical Hospital Centre Osijek
ðŸ‡ðŸ‡·Osijek, Croatia
Hopital Claude Huriez - CHU Lille
🇫🇷Lille cedex, Nord, France
Markhot Ferenc Oktatokorhaz es Rendelointezet
ðŸ‡ðŸ‡ºEger, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
ðŸ‡ðŸ‡ºSzeged, Hungary
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Klaipeda Republican Hospital, Public Institution
🇱🇹Klaipeda, Lithuania
Universitair Medisch Centrum Groningen (UMCG)
🇳🇱Groningen, Netherlands
NZOZ Vitamed
🇵🇱Bydgoszcz, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Institutul Clinic Fundeni
🇷🇴Bucuresti, Romania
SPb SBIH "City Hospital # 26"
🇷🇺Saint-Petersburg, Russian Federation
IBDcentrum s.r.o.
🇸🇰Bratislava, Slovakia
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
Fourth MHAT - Sofia EAD
🇧🇬Sofia, Bulgaria
Monash Medical Centre Moorabbin
🇦🇺Clayton, Victoria, Australia
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
🇵🇹Vila Nova de Gaia, Portugal
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
UMHAT "Sv. Ivan Rilski", EAD
🇧🇬Sofia, Bulgaria
Clinical Hospital Center "Sestre Milosrdnice"
ðŸ‡ðŸ‡·Zagreb, Croatia
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
CHU Saint Etienne - Hopital Nord
🇫🇷Saint Etienne, Loire, France
Tolna Megyei Balassa Janos Korhaz
ðŸ‡ðŸ‡ºSzekszard, Hungary
Hillel Yaffe Medical
🇮🇱Hadera, Israel
Clalit Health Services-Lev Talpiyot
🇮🇱Jerusalem, Israel
UMHAT 'Dr. Georgi Stranski', EAD
🇧🇬Pleven, Bulgaria
Clinical Hospital Merkur
ðŸ‡ðŸ‡·Zagreb, Croatia
CHU Amiens - Hopital Sud
🇫🇷Amiens Cedex, Somme, France
Wolfson Medical Center
🇮🇱Holon, Israel
Meir Medical Center
🇮🇱Kfar- Saba, Israel
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Foggia, Italy
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
🇲🇽Durango, Mexico
SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
🇷🇺Nizhny Novgorod, Russian Federation
Clinical Center Bezanijska kosa
🇷🇸Belgrade, Serbia
Clinical Center Zemun
🇷🇸Belgrade, Serbia
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
🇧🇬Stara Zagora, Bulgaria
Instituto de Coloproctologia ICO S.A.S.
🇨🇴Medellin, Colombia
Polyclinic Medico
ðŸ‡ðŸ‡·Rijeka, Croatia
Clinical Hospital Centre Zagreb
ðŸ‡ðŸ‡·Zagreb, Croatia
Tuen Mun Hospital
ðŸ‡ðŸ‡°Medicine & Geriatrics, Hong Kong
Pecsi Tudomanyegyetem
ðŸ‡ðŸ‡ºPecs, Hungary
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
SP CSK im. prof. K. Gibinskiego SUM
🇵🇱Katowice, Poland
Private Educational Institution of Higher Education "Medical University "REAVIZ"
🇷🇺Samara, Russian Federation
SBIH of Yaroslavl region " Regional Clinical Hospital "
🇷🇺Yaroslavl, Russian Federation
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
ðŸ‡ðŸ‡ºBudapest, Hungary
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
🇱🇹Kaunas, Lithuania
Klaipeda University Hospital, Public Institution
🇱🇹Klaipeda, Lithuania
Christus Muguerza Sur S.A. de C.V.
🇲🇽Monterrey, Nuevo Leon, Mexico
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Hospital da Senhora da Oliveira Guimaraes
🇵🇹Guimaraes, Portugal
SBEI HPE "Kazan State Medical University" of the MoH of the RF
🇷🇺Kazan, Russian Federation
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
🇷🇺Novosibirsk, Russian Federation
SPb SBIH "City Hospital # 40 of Kurortnyi region"
🇷🇺Sestroretsk, Russian Federation
CI of Kyiv RC Kyiv Regional Clinical Hospital
🇺🇦Kyiv, Ukraine
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
🇷🇺Moscow, Russian Federation
Clinical Center Nis
🇷🇸Nis, Serbia
SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
🇺🇦Dnipropetrovsk, Ukraine
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
🇺🇦Kyiv, Ukraine
CI of PH Kharkiv CCH #2
🇺🇦Kharkiv, Ukraine
SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
🇺🇦Zaporizhzhia, Ukraine
CI A.and O. Tropiny City Clinical Hospital
🇺🇦Kherson, Ukraine
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
🇺🇦Kyiv, Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
🇺🇦Lviv, Ukraine
CI Odesa Regional Clinical Hospital
🇺🇦Odesa, Ukraine
Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
🇺🇦Vinnytsia, Ukraine
MCIC MC LLC Health Clinic
🇺🇦Vinnytsia, Ukraine
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
🇺🇦Vinnytsia, Ukraine
CI City Clinical Hospital #6 Dept of Gastroenterology
🇺🇦Zaporizhzhia, Ukraine
Derriford Hospital
🇬🇧Plymouth, Devon, United Kingdom
Spitalul Clinic Colentina
🇷🇴Bucuresti, Romania
SBEIHPE Novosibirsk State Medical University
🇷🇺Novosibirsk, Russian Federation
Nordsjallands Hospital, Frederikssund
🇩🇰Frederikssund, Denmark
Hvidovre_Hospital
🇩🇰Hvidovre, Denmark
Koge Sygehus
🇩🇰Koge, Denmark
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States
Hopital Nord - CHU Marseille
🇫🇷Marseille cedex 20, Bouches-du-Rhone, France
Hopital Saint Joseph
🇫🇷Marseille, Bouches-du-Rhone, France
LHSC - Victoria Hospital
🇨🇦London, Ontario, Canada
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Alegent Creighton Clinic Gastroenterology
🇺🇸Omaha, Nebraska, United States
Allegiance Research Specialists, LLC
🇺🇸Milwaukee, Wisconsin, United States
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Digestive Disease Care
🇺🇸New Hyde Park, New York, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Truman Medical Centers, Inc.
🇺🇸Kansas City, Missouri, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
The University of Hong Kong
ðŸ‡ðŸ‡°Hong Kong, Hong Kong