An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
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
4 other identifiers
interventional
771
33 countries
326
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Typical duration for phase_3
326 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2015
CompletedFirst Submitted
Initial submission to the registry
July 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2019
CompletedResults Posted
Study results publicly available
October 10, 2019
CompletedJanuary 28, 2020
January 1, 2020
3.2 years
July 10, 2015
September 17, 2019
January 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved Clinical Remission
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).
Week 52
Secondary Outcomes (2)
Percentage of Participants Who Achieved Mucosal Healing
Week 52
Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission
Week 52
Study Arms (2)
Vedolizumab IV 300 mg
EXPERIMENTALVedolizumab 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
ACTIVE COMPARATORAdalimumab 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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 naĂ¯ve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate \[5-ASA\], or immunomodulators).
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (330)
IMC - Diagnostic and Medical Clinic
Mobile, Alabama, 36604, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85037, United States
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204, United States
WCCT Global (PH 1 Unit)
Costa Mesa, California, 92626, United States
California Medical Research Associates Inc.
Northridge, California, 91324, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, 80214-5434, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, 33180, United States
Advanced Clinical Research of Miami
Doral, Florida, 33172, United States
Wellness Clinical Research
Hialeah Gardens, Florida, 33016, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452, United States
Florida Center for Gastroenterology
Largo, Florida, 33773-1615, United States
Gastro Health
Miami, Florida, 33143, United States
Medical Professional Clinical Research
Miami, Florida, 33165, United States
Tellus Clinical Research, Inc.
Miami, Florida, 33173, United States
South Florida Research Phase I-IV
Miami Springs, Florida, 33166, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
BRCR Medical Center, Inc.
Plantation, Florida, 33322, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Gastroenterology of Southern Associates
New Albany, Indiana, 47150, United States
Iowa Digestive Disease Center
Clive, Iowa, 50325, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Research Concierge, LLC
Owensboro, Kentucky, 42303, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Lafayette General Medical Center
Lafayette, Louisiana, 70503, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
Digestive Disease Associates
Catonsville, Maryland, 21228, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Center for Digestive Health and Nutritional Excellence
Troy, Michigan, 48098, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Digestive Health Center PA
Ocean Springs, Mississippi, 39564, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, 64012, United States
Truman Medical Centers, Inc.
Kansas City, Missouri, 64108, United States
Alegent Creighton Clinic Gastroenterology
Omaha, Nebraska, 68124, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Mount Sinai - PRIME
Lake Success, New York, 10029, United States
Digestive Disease Care
New Hyde Park, New York, 11040, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12601, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7080, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, 45219, United States
Ohio State University Clinical Trials Management Office
Columbus, Ohio, 43210, United States
Dayton Gastroenterology, Inc
Dayton, Ohio, 45415, United States
Gastro-Enterology Research of Lima
Lima, Ohio, 45806, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
The Oregon Clinic-West Hills Gastroenterology
Portland, Oregon, 97225, United States
Main Line Gastroenterology Associates
Malvern, Pennsylvania, 19355, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Invocare Clinical Research Center
West Columbia, South Carolina, 29169, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-1375, United States
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, 75231, United States
Baylor University Hospital
Dallas, Texas, 75246, United States
MedResearch, Inc
El Paso, Texas, 79935, United States
Gastroenterology Consultants of South Texas, PA
Harlingen, Texas, 78550, United States
Gulf Coast Research Group LLC
Houston, Texas, 77098, United States
Texas Digestive Disease Consultants - Irving
Irving, Texas, 75039, United States
Advanced Clinical Research Associates
Plano, Texas, 75093, United States
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, 76092, United States
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Virginia Mason Seattle Main Clinic
Seattle, Washington, 98101, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Allegiance Research Specialists, LLC
Milwaukee, Wisconsin, 53226, United States
Instituto de Investigaciones Clinicas-Mar del Plata
Mar del Plata, Buenos Aires, B7600FZ, Argentina
Instituto Medico CER
Quilmes, Buenos Aires, B1878DVB, Argentina
Expertia S.A- Mautalen Salud e Investigacion
Ciudad Autonoma Buenos Aires, C1128AAE, Argentina
Centro de Investigaciones Clinicas Instituto del Corazon
CĂ³rdoba, X5000EVQ, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Tennyson Centre Day Hospital
Bedford Park, South Australia, 5042, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
Monash Medical Centre Moorabbin
Clayton, Victoria, 3168, Australia
St Frances Xavier Cabrini Hospital
Malvern, Victoria, 3144, Australia
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, 88000, Bosnia and Herzegovina
University Clinic Centre Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
MHAT - Pazardzhik AD
Pazardzhik, 4400, Bulgaria
MHAT 'Avis Medica' OOD
Pleven, 5800, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
MHAT "Hadzhi Dimitar", OOD
Sliven, 8800, Bulgaria
"City Clinic UMHAC" EOOD
Sofia, 1407, Bulgaria
Medical Center "Excelsior", OOD
Sofia, 1407, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527, Bulgaria
Fourth MHAT - Sofia EAD
Sofia, 1606, Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, 1606, Bulgaria
UMHAT 'Sveta Anna' AD
Sofia, 1750, Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, 6000, Bulgaria
MHAT 'Sv. Marina', EAD
Varna, 9020, Bulgaria
University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
McMaster University Health Sciences Center
Hamilton, Ontario, L8N3Z5, Canada
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
LHSC - University Hospital
London, Ontario, N6A 5A5, Canada
LHSC - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, 681004, Colombia
Instituto de Coloproctologia ICO S.A.S.
MedellĂn, 050025, Colombia
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
General Hospital Pula
Pula, 52100, Croatia
Polyclinic Medico
Rijeka, 51000, Croatia
Clinical Hospital Center "Sestre Milosrdnice"
Zagreb, 10000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Clinical Hospital Merkur
Zagreb, 10000, Croatia
CCBR - Brno - CZ
Brno, 60200, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, 65691, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec KrĂ¡lovĂ©, 500 12, Czechia
CCBR Czech, a.s
Pardubice, 530 02, Czechia
A-Shine
Pilsen, 31200, Czechia
CCBR - Prague - CZ
Prague, 13000, Czechia
Klinicke centrum ISCARE Lighthouse
Prague, 17004, Czechia
Axon Clinical, s.r.o.
Prague, 182 00, Czechia
Thomayerova nemocnice
Praha 4 - Krc, 140 59, Czechia
Nordsjallands Hospital, Frederikssund
Frederikssund, 3600, Denmark
Hvidovre_Hospital
Hvidovre, 2650, Denmark
Koge Sygehus
Køge, 4600, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
West Tallinn Central Hospital
Tallinn, 10617, Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 50406, Estonia
CHU Nice - Hopital de l'Archet 2
Nice, Alpes Maritimes, 06200, France
Hopital Saint Joseph
Marseille, Bouches-du-Rhone, 13008, France
Hopital Nord - CHU Marseille
Marseille, Bouches-du-Rhone, 13915, France
Groupe Hospitalier Sud - Hopital Haut-Leveque
Pessac, Gironde, 33604, France
CHU de Toulouse - Hopital Rangueil
Toulouse, Haute Garonne, 31059, France
Hopital Beaujon
Clichy, Hauts De Seine, 92110, France
Hopital de Brabois Adultes
VandÅ“uvre-lès-Nancy, Meurthe Et Moselle, 54511, France
Hopital Claude Huriez - CHU Lille
Lille, Nord, 59037, France
CHU Saint Etienne - Hopital Nord
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
CHU Amiens - Hopital Sud
Amiens, Somme, 80054, France
Centre Hospitalier Departemental Les Oudairies
La Roche S/ Yon Cedex 9, Vendee, 85925, France
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitaetsklinikum Tuebingen
TĂ¼bingen, Baden-Wurttemberg, 72076, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, Hesse, 60590, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
EUGASTRO GmbH
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Magdeburg A.oe.R
Magdeburg, Saxony-Anhalt, 39120, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
LĂ¼beck, Schleswig-Holstein, 23538, Germany
Charite - Campus Virchow-Klinikum
Berlin, 13353, Germany
Krankenhaus Waldfriede e. V.
Berlin, 141 63, Germany
Asklepios Klinik Hamburg
Hamburg, 22559, Germany
The University of Hong Kong
Hong Kong, Hong Kong
Tuen Mun Hospital
Medicine & Geriatrics, 00000, Hong Kong
The Chinese University of Hong Kong
Shatin, 00000, Hong Kong
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, 5600, Hungary
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
Budapest, 1076, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, 3300, Hungary
Pecsi Tudomanyegyetem
PĂ©cs, 7624, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6720, Hungary
Tolna Megyei Balassa Janos Korhaz
SzekszĂ¡rd, 7100, Hungary
HaEmek Medical Center
Afula, 18101, Israel
Barzilai Medical Center
Ashkelon, 78278, Israel
Hillel Yaffe Medical
Hadera, 3810101, Israel
Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Clalit Health Services-Lev Talpiyot
Jerusalem, 9362410, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Galilee Medical Center
Nahariya, 22100, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Ospedale Cannizzaro
Catania, 95100, Italy
Azienda Ospedaliero Universitaria San Martino
Genova, 16132, Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, 98125, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, 20157, Italy
A.O.U. Policlinico di Modena
Modena, 41124, Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, 80131, Italy
Seconda Universita degli Studi di Napoli
Napoli, 80131, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Azienda Ospedaliera Vincenzo Cervello
Palermo, 90146, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
Digestive Diseases Center "Gastro"
Riga, LV-1006, Latvia
Pauls Stradins Clinical University Hospital SLLC
Riga, LV1002, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50009, Lithuania
Klaipeda Republican Hospital, Public Institution
KlaipÄ—da, 92231, Lithuania
Klaipeda University Hospital, Public Institution
KlaipÄ—da, 92288, Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution
Vilnius, LT-08661, Lithuania
Morales Vargas Centro de Investigacion, S.C.
LeĂ³n, Guanajuato, 37000, Mexico
Centro de Investigacion Farmacologica del Bajio, S.C.
LeĂ³n, Guanajuato, 37520, Mexico
Christus Muguerza Sur S.A. de C.V.
Monterrey, Nuevo LeĂ³n, 64908, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Sociedad de Metabolismo y Corazon S.C
Veracruz, 91910, Mexico
Onze Lieve Vrouwe Gasthuis, Locatie Oost
Amsterdam, 1091 AC, Netherlands
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, 9713 GZ, Netherlands
Maastricht University Medical Center
Maastricht, 6202 AZ, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CE, Netherlands
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, 15-275, Poland
NZOZ Vitamed
Bydgoszcz, 85-079, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
SP CSK im. prof. K. Gibinskiego SUM
Katowice, 40-752, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
Lodz, 90-153, Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302, Poland
GASTROMED Sp. z o.o.
Lublin, 20-582, Poland
SOLUMED Centrum Medyczne
Poznan, 60-529, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, 00-632, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02-781, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114, Poland
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
Wroclaw, 53-333, Poland
EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu
Wroclaw, 54-144, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar e Universitario de Coimbra E.P.E
Coimbra, 3000-075, Portugal
Centro Hospitalar Cova da Beira
Covilha, 6200-502, Portugal
Hospital da Senhora da Oliveira Guimaraes
GuimarĂ£es, 4835-044, Portugal
Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE
Viana do Castelo, 4904-858, Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, 4434-502, Portugal
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002, Romania
SBEI HPE "Kazan State Medical University" of the MoH of the RF
Kazan', 420012, Russia
TSBIH "Territorial Clinical Hospital"
Krasnoyarsk, 660022, Russia
Research Institute of Gastroenterology
Moscow, 111123, Russia
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
Moscow, 119333, Russia
FSBI State Scientific Centre of Coloproctology" of the MoH of RF
Moscow, 123154, Russia
SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
Nizhny Novgorod, 603126, Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, 630091, Russia
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
Novosibirsk, 630117, Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013, Russia
SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
Omsk, 644099, Russia
SBEI HPE "Rostov State Medical University" of the MoH of the RF
Rostov-on-Don, 344022, Russia
FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
Saint Petersburg, 194044, Russia
SPb SBIH "City Hospital of Saint Martyr Elizaveta"
Saint Petersburg, 195257, Russia
SPb SBIH "City Hospital # 26"
Saint Petersburg, 196247, Russia
SPb SBIH "City Hospital # 9"
Saint Petersburg, 197110, Russia
Private Educational Institution of Higher Education "Medical University "REAVIZ"
Samara, 443115, Russia
SIH "Regional Clinical Hospital "
Saratov, 410053, Russia
SPb SBIH "City Hospital # 40 of Kurortnyi region"
Sestroretsk, 197706, Russia
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk, 214019, Russia
SBIH of Yaroslavl region " Regional Clinical Hospital "
Yaroslavl, 150062, Russia
Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical Center Zvezdara
Belgrade, 11000, Serbia
Clinical Center Bezanijska kosa
Belgrade, 11080, Serbia
Clinical Center Zemun
Belgrade, 11080, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center Nis
Niš, 18000, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
IBDcentrum s.r.o.
Bratislava, 81108, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 82606, Slovakia
Gastroped s.r.o.
Košice, 04001, Slovakia
KM Management spol. s r.o.
Nitra, 949 01, Slovakia
Gastro I, s.r.o.
Prešov, 080 01, Slovakia
Frantisek Horvath- GEA
Å ahy, 936 01, Slovakia
Hanyang Univerisy Guri Hospital
Guri-si, Gyeonggi-do, 11923, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Kyungpook National University Hospital
Daegu, Gyeongsangbuk-do, 700-721, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, 06591, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Ankara University Medical Faculty
Ankara, 06100, Turkey (TĂ¼rkiye)
Acibadem Fulya Hospital
Istanbul, 34349, Turkey (TĂ¼rkiye)
Haydarpasa Numune Training and Research Hospital
Istanbul, 34668, Turkey (TĂ¼rkiye)
Marmara University Pendik Research and Training Hospital
Istanbul, 34899, Turkey (TĂ¼rkiye)
Kocaeli Derince Training and Research Hospital
Kocaeli, 41380, Turkey (TĂ¼rkiye)
Mersin University Medical Faculty
Mersin, 33343, Turkey (TĂ¼rkiye)
RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
Chernivtsi, 58002, Ukraine
SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
Dnipropetrovsk, 49074, Ukraine
Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76008, Ukraine
CI of PH Kharkiv CCH #2
Kharkiv, 61037, Ukraine
CI A.and O. Tropiny City Clinical Hospital
Kherson, 73000, Ukraine
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
Kirovohrad, 25006, Ukraine
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, 01023, Ukraine
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
Kyiv, 01023, Ukraine
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
Kyiv, 01103, Ukraine
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
Kyiv, 04201, Ukraine
CI of TRC Ternopil University Hospital
Lviv, 46002, Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv, 79059, Ukraine
CI Odesa Regional Clinical Hospital
Odesa, 65025, Ukraine
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
Uzhhorod, 88009, Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001, Ukraine
Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, 21005, Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, 21029, Ukraine
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
Vinnytsia, 21029, Ukraine
CI City Clinical Hospital #6 Dept of Gastroenterology
Zaporizhzhia, 69035, Ukraine
SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
Zaporizhzhia, 69104, Ukraine
Derriford Hospital
Plymouth, Devon, PL6 5FP, United Kingdom
Salford Royal
Salford, Greater Manchester, M6 8HD, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR47UY, United Kingdom
Glasgow Royal Infirmary
Glasgow, Strathclyde, G4 0SF, United Kingdom
University Hospital Coventry
Coventry, West Midlands, CV2 2DX, United Kingdom
Royal Wolverhampton hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Related Publications (3)
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.
PMID: 35934286DERIVEDPeyrin-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.
PMID: 34144047DERIVEDSands 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.
PMID: 31553834DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2015
First Posted
July 14, 2015
Study Start
June 29, 2015
Primary Completion
September 26, 2018
Study Completion
January 18, 2019
Last Updated
January 28, 2020
Results First Posted
October 10, 2019
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.