Clinical trial NCT02497469: An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
Official title: A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 771
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Has evidence of ulcerative colitis proximal to the rectum (\>=15 centimeter \[cm\] of involved colon).
4. 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).
5. The participant:

   1. 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
   2. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued its use due to reasons other than safety, or
   3. Is naïve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate \[5-ASA\], or immunomodulators).

Exclusion Criteria:

1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.
2. Has had an extensive colonic resection, subtotal or total colectomy.
3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
5. Has received any of the following for the treatment of underlying disease within 30 days of randomization:

   1. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in Section Permitted Medications For Treatment of UC.
   2. An approved non-biologic therapy in an investigational protocol.
6. Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
7. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 antibodies, or rituximab.
8. Has previously received vedolizumab.
9. Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
10. Evidence of an active infection during Screening.
11. Evidence of, or treatment for, Clostridium difficile (C. difficile) or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
12. 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).
13. Has active or latent TB, regardless of treatment history.
14. 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.
15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Who Achieved Mucosal Healing
timeFrame: Week 52
measure: Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission
timeFrame: Week 52
Other outcomes:
Locations:
city: Mobile
country: United States
facility: IMC - Diagnostic and Medical Clinic
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic, PA
state: Arkansas
city: Costa Mesa
country: United States
facility: WCCT Global (PH 1 Unit)
state: California
city: Northridge
country: United States
facility: California Medical Research Associates Inc.
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Doral
country: United States
facility: Advanced Clinical Research of Miami
state: Florida
city: Hialeah Gardens
country: United States
facility: Wellness Clinical Research
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV
state: Florida
city: Miami
country: United States
facility: Gastro Health
state: Florida
city: Miami
country: United States
facility: Medical Professional Clinical Research
state: Florida
city: Miami
country: United States
facility: Tellus Clinical Research, Inc.
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center, Inc.
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: New Albany
country: United States
facility: Gastroenterology of Southern Associates
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Owensboro
country: United States
facility: Research Concierge, LLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Lafayette
country: United States
facility: Lafayette General Medical Center
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Catonsville
country: United States
facility: Digestive Disease Associates
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health and Nutritional Excellence
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, P.L.C.
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Ocean Springs
country: United States
facility: Digestive Health Center PA
state: Mississippi
city: Belton
country: United States
facility: Ehrhardt Clinical Research, LLC
state: Missouri
city: Kansas City
country: United States
facility: Truman Medical Centers, Inc.
state: Missouri
city: Omaha
country: United States
facility: Alegent Creighton Clinic Gastroenterology
state: Nebraska
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Lake Success
country: United States
facility: Mount Sinai - PRIME
state: New York
city: New Hyde Park
country: United States
facility: Digestive Disease Care
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research Inc.
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Clinical Trials Management Office
state: Ohio
city: Dayton
country: United States
facility: Dayton Gastroenterology, Inc
state: Ohio
city: Lima
country: United States
facility: Gastro-Enterology Research of Lima
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic-West Hills Gastroenterology
state: Oregon
city: Malvern
country: United States
facility: Main Line Gastroenterology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: West Columbia
country: United States
facility: Invocare Clinical Research Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants - Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor University Hospital
state: Texas
city: El Paso
country: United States
facility: MedResearch, Inc
state: Texas
city: Harlingen
country: United States
facility: Gastroenterology Consultants of South Texas, PA
state: Texas
city: Houston
country: United States
facility: Gulf Coast Research Group LLC
state: Texas
city: Irving
country: United States
facility: Texas Digestive Disease Consultants - Irving
state: Texas
city: Plano
country: United States
facility: Advanced Clinical Research Associates
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio, LLC
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Seattle Main Clinic
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Allegiance Research Specialists, LLC
state: Wisconsin
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas-Mar del Plata
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto Medico CER
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Expertia S.A- Mautalen Salud e Investigacion
city: Cordoba
country: Argentina
facility: Centro de Investigaciones Clinicas Instituto del Corazon
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Tennyson Centre Day Hospital
state: South Australia
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre Moorabbin
state: Victoria
city: Malvern
country: Australia
facility: St Frances Xavier Cabrini Hospital
state: Victoria
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinic Centre Sarajevo
city: Pazardzhik
country: Bulgaria
facility: MHAT - Pazardzhik AD
city: Pleven
country: Bulgaria
facility: MHAT 'Avis Medica' OOD
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Sliven
country: Bulgaria
facility: MHAT "Hadzhi Dimitar", OOD
city: Sofia
country: Bulgaria
facility: "City Clinic UMHAC" EOOD
city: Sofia
country: Bulgaria
facility: Medical Center "Excelsior", OOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Yoanna - ISUL', EAD
city: Sofia
country: Bulgaria
facility: Fourth MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - MHAT - Sofia
city: Sofia
country: Bulgaria
facility: UMHAT 'Sveta Anna' AD
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Varna
country: Bulgaria
facility: MHAT 'Sv. Marina', EAD
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University Health Sciences Center
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: London
country: Canada
facility: LHSC - University Hospital
state: Ontario
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc.
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmologica de Santander - FOSCAL
city: Medellin
country: Colombia
facility: Instituto de Coloproctologia ICO S.A.S.
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Pula
country: Croatia
facility: General Hospital Pula
city: Rijeka
country: Croatia
facility: Polyclinic Medico
city: Zagreb
country: Croatia
facility: Clinical Hospital Center "Sestre Milosrdnice"
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Zagreb
country: Croatia
facility: Clinical Hospital Merkur
city: Brno
country: Czechia
facility: CCBR - Brno - CZ
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Pardubice
country: Czechia
facility: CCBR Czech, a.s
city: Plzen
country: Czechia
facility: A-Shine
city: Praha 3
country: Czechia
facility: CCBR - Prague - CZ
city: Praha 4 - Krc
country: Czechia
facility: Thomayerova nemocnice
city: Praha 7
country: Czechia
facility: Klinicke centrum ISCARE Lighthouse
city: Praha 8
country: Czechia
facility: Axon Clinical, s.r.o.
city: Frederikssund
country: Denmark
facility: Nordsjallands Hospital, Frederikssund
city: Hvidovre
country: Denmark
facility: Hvidovre_Hospital
city: Koge
country: Denmark
facility: Koge Sygehus
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Nice Cedex 3
country: France
facility: CHU Nice - Hopital de l'Archet 2
state: Alpes Maritimes
city: Marseille cedex 20
country: France
facility: Hopital Nord - CHU Marseille
state: Bouches-du-Rhone
city: Marseille
country: France
facility: Hopital Saint Joseph
state: Bouches-du-Rhone
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hopital Haut-Leveque
state: Gironde
city: Toulouse Cedex 09
country: France
facility: CHU de Toulouse - Hopital Rangueil
state: Haute Garonne
city: Clichy cedex
country: France
facility: Hopital Beaujon
state: Hauts De Seine
city: Saint Etienne
country: France
facility: CHU Saint Etienne - Hopital Nord
state: Loire
city: Vandoeuvre les Nancy
country: France
facility: Hopital de Brabois Adultes
state: Meurthe Et Moselle
city: Lille cedex
country: France
facility: Hopital Claude Huriez - CHU Lille
state: Nord
city: Amiens Cedex
country: France
facility: CHU Amiens - Hopital Sud
state: Somme
city: La Roche S/ Yon Cedex 9
country: France
facility: Centre Hospitalier Departemental Les Oudairies
state: Vendee
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
state: Baden Wuerttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden Wuerttemberg
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
state: Hessen
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein Westfalen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
state: Rheinland Pfalz
city: Magdeburg
country: Germany
facility: Universitaetsklinikum Magdeburg A.oe.R
state: Sachsen Anhalt
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
state: Schleswig Holstein
city: Lubeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
state: Schleswig Holstein
city: Berlin
country: Germany
facility: Charite - Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e. V.
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
city: Medicine & Geriatrics
country: Hong Kong
facility: Tuen Mun Hospital
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Eger
country: Hungary
facility: Markhot Ferenc Oktatokorhaz es Rendelointezet
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Clalit Health Services-Lev Talpiyot
city: Kfar- Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S Policlinico San Donato
state: Milano
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliera Ospedale Cannizzaro
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G. Martino
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Napoli
country: Italy
facility: Seconda Universita degli Studi di Napoli
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Palermo
country: Italy
facility: Azienda Ospedaliera Vincenzo Cervello
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Guri-si
country: Korea, Republic of
facility: Hanyang Univerisy Guri Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Gyeongsangbuk-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital
city: Riga
country: Latvia
facility: Digestive Diseases Center "Gastro"
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital SLLC
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Klaipeda
country: Lithuania
facility: Klaipeda Republican Hospital, Public Institution
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Public Institution
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion, S.C.
state: Guanajuato
city: Leon
country: Mexico
facility: Centro de Investigacion Farmacologica del Bajio, S.C.
state: Guanajuato
city: Monterrey
country: Mexico
facility: Christus Muguerza Sur S.A. de C.V.
state: Nuevo Leon
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis, Locatie Oost
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen (UMCG)
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Bialystok
country: Poland
facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: SP CSK im. prof. K. Gibinskiego SUM
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
city: Lodz
country: Poland
facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia
city: Lublin
country: Poland
facility: GASTROMED Sp. z o.o.
city: Poznan
country: Poland
facility: SOLUMED Centrum Medyczne
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Warszawa
country: Poland
facility: Nzoz Vivamed
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Wroclaw
country: Poland
facility: Ars-Medica S.C Rybak Maria, Rybak Zbigniew
city: Wroclaw
country: Poland
facility: EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra E.P.E
city: Covilha
country: Portugal
facility: Centro Hospitalar Cova da Beira
city: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes
city: Viana do Castelo
country: Portugal
facility: Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Timisoara
country: Romania
facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
city: Kazan
country: Russian Federation
facility: SBEI HPE "Kazan State Medical University" of the MoH of the RF
city: Krasnoyarsk
country: Russian Federation
facility: TSBIH "Territorial Clinical Hospital"
city: Moscow
country: Russian Federation
facility: Research Institute of Gastroenterology
city: Moscow
country: Russian Federation
facility: FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
city: Moscow
country: Russian Federation
facility: FSBI State Scientific Centre of Coloproctology" of the MoH of RF
city: Nizhny Novgorod
country: Russian Federation
facility: SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
city: Novosibirsk
country: Russian Federation
facility: SBEIHPE Novosibirsk State Medical University
city: Novosibirsk
country: Russian Federation
facility: FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
city: Omsk
country: Russian Federation
facility: BHI of Omsk region Clinical Oncology Dispensary
city: Omsk
country: Russian Federation
facility: SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
city: Rostov-on-Don
country: Russian Federation
facility: SBEI HPE "Rostov State Medical University" of the MoH of the RF
city: Saint-Petersburg
country: Russian Federation
facility: FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH "City Hospital # 26"
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH "City Hospital # 9"
city: Samara
country: Russian Federation
facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"
city: Saratov
country: Russian Federation
facility: SIH "Regional Clinical Hospital "
city: Sestroretsk
country: Russian Federation
facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"
city: Smolensk
country: Russian Federation
facility: RSBIH "Smolensk Regional Clinical Hospital"
city: St. Petersburg
country: Russian Federation
facility: SPb SBIH "City Hospital of Saint Martyr Elizaveta"
city: Yaroslavl
country: Russian Federation
facility: SBIH of Yaroslavl region " Regional Clinical Hospital "
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Center Zvezdara
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska kosa
city: Belgrade
country: Serbia
facility: Clinical Center Zemun
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Nis
country: Serbia
facility: Clinical Center Nis
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Bratislava
country: Slovakia
facility: IBDcentrum s.r.o.
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
city: Kosice
country: Slovakia
facility: Gastroped s.r.o.
city: Nitra
country: Slovakia
facility: KM Management spol. s r.o.
city: Presov
country: Slovakia
facility: Gastro I, s.r.o.
city: Sahy
country: Slovakia
facility: Frantisek Horvath- GEA
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli Derince Training and Research Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Chernivtsi
country: Ukraine
facility: RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
city: Dnipropetrovsk
country: Ukraine
facility: SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
city: Ivano-Frankivsk
country: Ukraine
facility: Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
city: Kharkiv
country: Ukraine
facility: CI of PH Kharkiv CCH #2
city: Kherson
country: Ukraine
facility: CI A.and O. Tropiny City Clinical Hospital
city: Kirovohrad
country: Ukraine
facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Kyiv Regional Clinical Hospital
city: Kyiv
country: Ukraine
facility: MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
city: Kyiv
country: Ukraine
facility: Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
city: Kyiv
country: Ukraine
facility: Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
city: Lviv
country: Ukraine
facility: CI of TRC Ternopil University Hospital
city: Lviv
country: Ukraine
facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
city: Odesa
country: Ukraine
facility: CI Odesa Regional Clinical Hospital
city: Uzhgorod
country: Ukraine
facility: SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
city: Vinnytsia
country: Ukraine
facility: Private Small Enterprise Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
city: Vinnytsia
country: Ukraine
facility: MCIC MC LLC Health Clinic
city: Vinnytsia
country: Ukraine
facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
city: Zaporizhzhia
country: Ukraine
facility: CI City Clinical Hospital #6 Dept of Gastroenterology
city: Zaporizhzhia
country: Ukraine
facility: SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: Salford
country: United Kingdom
facility: Salford Royal
state: Greater Manchester
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
state: Strathclyde
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
state: West Midlands
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton hospital
state: West Midlands
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.
citation: Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Danese S, Rogers R, Bornstein JD, Chen J, Schreiber S, Sands BE, Lirio RA. Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY). Gastroenterology. 2021 Oct;161(4):1156-1167.e3. doi: 10.1053/j.gastro.2021.06.015. Epub 2021 Jun 16.
citation: Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Toruner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.