An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

771

Participants

Timeline

Start Date

June 29, 2015

Primary Completion Date

September 26, 2018

Study Completion Date

January 18, 2019

Conditions
Colitis, Ulcerative
Interventions
DRUG

Vedolizumab

Vedolizumab infusion

DRUG

Adalimumab placebo

Adalimumab placebo-matching injection

DRUG

Adalimumab

Adalimumab injection

DRUG

Vedolizumab placebo

Vedolizumab placebo-matching infusion

Trial Locations (330)

100

National Taiwan University Hospital, Taipei

402

Chung Shan Medical University Hospital, Taichung

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1076

Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Budapest

1083

Semmelweis Egyetem, Budapest

1088

Semmelweis Egyetem, Budapest

1136

Pannonia Maganorvosi Centrum, Budapest

1407

"City Clinic UMHAC EOOD", Sofia

"Medical Center Excelsior, OOD", Sofia

1431

"UMHAT Sv. Ivan Rilski, EAD", Sofia

1527

UMHAT 'Tsaritsa Yoanna - ISUL', EAD, Sofia

1606

Fourth MHAT - Sofia EAD, Sofia

Military Medical Academy - MHAT - Sofia, Sofia

1750

UMHAT 'Sveta Anna' AD, Sofia

2139

Concord Repatriation General Hospital, Concord

2650

Hvidovre_Hospital, Hvidovre

3144

St Frances Xavier Cabrini Hospital, Malvern

3168

Monash Medical Centre Moorabbin, Clayton

3300

Markhot Ferenc Oktatokorhaz es Rendelointezet, Eger

3350

Ballarat Base Hospital, Ballarat

3600

Nordsjallands Hospital, Frederikssund, Frederikssund

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4101

Mater Adult Hospital, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4400

MHAT - Pazardzhik AD, Pazardzhik

4600

Koge Sygehus, Køge

5000

Royal Adelaide Hospital, Adelaide

Odense Universitetshospital, Odense C

5042

Tennyson Centre Day Hospital, Bedford Park

5600

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza, Békéscsaba

5800

MHAT 'Avis Medica' OOD, Pleven

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

6000

"Medical Center Nov Rehabilitatsionen Tsentar, EOOD", Stara Zagora

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

7100

Tolna Megyei Balassa Janos Korhaz, Szekszárd

7624

Pecsi Tudomanyegyetem, Pécs

8800

"MHAT Hadzhi Dimitar, OOD", Sliven

9000

Universitair Ziekenhuis Gent, Ghent

9020

MHAT 'Sv. Marina', EAD, Varna

10000

"Clinical Hospital Center Sestre Milosrdnice", Zagreb

Clinical Hospital Centre Zagreb, Zagreb

Clinical Hospital Dubrava, Zagreb

Clinical Hospital Merkur, Zagreb

10029

Mount Sinai - PRIME, Lake Success

10449

Mackay Memorial Hospital, Taipei

10617

West Tallinn Central Hospital, Tallinn

11000

Clinical Center of Serbia, Belgrade

Clinical Center Zvezdara, Belgrade

11021

Long Island Clinical Research Associates, Great Neck

11040

Digestive Disease Care, New Hyde Park

11080

Clinical Center Bezanijska kosa, Belgrade

Clinical Center Zemun, Belgrade

11923

Hanyang Univerisy Guri Hospital, Guri-si

12601

Premier Medical Group of the Hudson Valley, PC, Poughkeepsie

13000

CCBR - Prague - CZ, Prague

13008

Hopital Saint Joseph, Marseille

13353

Charite - Campus Virchow-Klinikum, Berlin

13419

North Estonia Medical Centre Foundation, Tallinn

13620

Seoul National University Bundang Hospital, Seongnam-si

13915

Hopital Nord - CHU Marseille, Marseille

16132

Azienda Ospedaliero Universitaria San Martino, Genova

16247

The Catholic University of Korea, St. Vincent's Hospital, Suwon

17004

Klinicke centrum ISCARE Lighthouse, Prague

18000

Clinical Center Nis, Niš

18101

HaEmek Medical Center, Afula

19355

Main Line Gastroenterology Associates, Malvern

20089

Istituto Clinico Humanitas, Rozzano

20097

I.R.C.C.S Policlinico San Donato, San Donato Milanese

20157

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco), Milan

20815

Chevy Chase Clinical Research, Chevy Chase

21000

Clinical Center of Vojvodina, Novi Sad

21001

Private Small Enterprise Medical Center Pulse, Vinnytsia

21005

Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU, Vinnytsia

21029

MCIC MC LLC Health Clinic, Vinnytsia

SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Vinnytsia

21228

Digestive Disease Associates, Catonsville

22100

Galilee Medical Center, Nahariya

22559

Asklepios Klinik Hamburg, Hamburg

23320

Gastroenterology Associates of Tidewater, Chesapeake

23538

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Lübeck

24105

Universitaetsklinikum Schleswig-Holstein - Campus Kiel, Kiel

25006

Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus, Kirovohrad

28034

Hospital Universitario Ramon y Cajal, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

29169

Invocare Clinical Research Center, West Columbia

29425

Medical University of South Carolina (MUSC), Charleston

30322

Emory University Hospital, Atlanta

31000

Clinical Hospital Centre Osijek, Osijek

31059

CHU de Toulouse - Hopital Rangueil, Toulouse

31200

A-Shine, Pilsen

31201

Gastroenterology Associates of Central Georgia, Macon

32789

Shafran Gastroenterology Center, Winter Park

32806

Internal Medicine Specialists, Orlando

33016

Wellness Clinical Research, Hialeah Gardens

33060

Clinical Research Center of Florida, Pompano Beach

33143

Gastro Health, Miami

33165

Medical Professional Clinical Research, Miami

33166

South Florida Research Phase I-IV, Miami Springs

33172

Advanced Clinical Research of Miami, Doral

33173

Tellus Clinical Research, Inc., Miami

33180

Innovative Medical Research of South Florida, Inc., Aventura

33322

BRCR Medical Center, Inc., Plantation

33343

Mersin University Medical Faculty, Mersin

33604

Groupe Hospitalier Sud - Hopital Haut-Leveque, Pessac

34000

Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango

Clinical Center Kragujevac, Kragujevac

34102

Gastroenterology Group of Naples, Naples

34349

Acibadem Fulya Hospital, Istanbul

34452

Nature Coast Clinical Research, LLC, Inverness

34668

Haydarpasa Numune Training and Research Hospital, Istanbul

34899

Marmara University Pendik Research and Training Hospital, Istanbul

35128

Azienda Ospedaliera di Padova, Padua

36604

IMC - Diagnostic and Medical Clinic, Mobile

37000

Morales Vargas Centro de Investigacion, S.C., León

37520

Centro de Investigacion Farmacologica del Bajio, S.C., León

39120

Universitaetsklinikum Magdeburg A.oe.R, Magdeburg

39564

Digestive Health Center PA, Ocean Springs

40138

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna

40202

University of Louisville, Louisville

41124

A.O.U. Policlinico di Modena, Modena

41380

Kocaeli Derince Training and Research Hospital, Kocaeli

42055

CHU Saint Etienne - Hopital Nord, Saint-Étienne-de-Montluc

42303

Research Concierge, LLC, Owensboro

42415

Yeungnam University Hospital, Daegu

43210

Ohio State University Clinical Trials Management Office, Columbus

45219

Consultants for Clinical Research Inc., Cincinnati

45415

Dayton Gastroenterology, Inc, Dayton

45806

Gastro-Enterology Research of Lima, Lima

46002

CI of TRC Ternopil University Hospital, Lviv

47150

Gastroenterology of Southern Associates, New Albany

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48098

Center for Digestive Health and Nutritional Excellence, Troy

49074

SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU, Dnipropetrovsk

49241

Pusan National University Hospital, Busan

49519

Gastroenterology Associates of Western Michigan, P.L.C., Wyoming

50009

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

50325

Iowa Digestive Disease Center, Clive

50406

Tartu University Hospital, Tartu

50937

Universitaetsklinikum Koeln, Cologne

51000

Polyclinic Medico, Rijeka

52100

General Hospital Pula, Pula

53226

Allegiance Research Specialists, LLC, Milwaukee

53705

University of Wisconsin, Madison

54511

Hopital de Brabois Adultes, Vandœuvre-lès-Nancy

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

55905

Mayo Clinic - Rochester, Rochester

56124

Azienda Ospedaliero Universitaria Pisana, Pisa

58002

RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU, Chernivtsi

58100

Wolfson Medical Center, Holon

59037

Hopital Claude Huriez - CHU Lille, Lille

60200

CCBR - Brno - CZ, Brno

60590

Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt am Main

60611

Northwestern University Feinberg School of Medicine, Chicago

60612

Rush University Medical Center, Chicago

61037

CI of PH Kharkiv CCH #2, Kharkiv

61801

Carle Foundation Hospital, Urbana

64012

Ehrhardt Clinical Research, LLC, Belton

64108

Truman Medical Centers, Inc., Kansas City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

64908

Christus Muguerza Sur S.A. de C.V., Monterrey

65025

CI Odesa Regional Clinical Hospital, Odesa

65691

Fakultni nemocnice u sv. Anny v Brne, Brno

66606

Cotton-O'Neil Clinical Research Center, Digestive Health, Topeka

68124

Alegent Creighton Clinic Gastroenterology, Omaha

69035

CI City Clinical Hospital #6 Dept of Gastroenterology, Zaporizhzhia

69104

SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU, Zaporizhzhia

69120

Universitaetsklinikum Heidelberg, Heidelberg

70006

Clinical Trials Management, LLC, Metairie

70503

Lafayette General Medical Center, Lafayette

70809

Gastroenterology Associates, LLC, Baton Rouge

71000

University Clinic Centre Sarajevo, Sarajevo

71013

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

71103

Louisiana Research Center, LLC, Shreveport

72076

Universitaetsklinikum Tuebingen, Tübingen

72204

Arkansas Primary Care Clinic, PA, Little Rock

73000

CI A.and O. Tropiny City Clinical Hospital, Kherson

74104

Options Health Research, Tulsa

75039

Texas Digestive Disease Consultants - Irving, Irving

75093

Advanced Clinical Research Associates, Plano

75231

Texas Digestive Disease Consultants - Dallas, Dallas

75246

Baylor University Hospital, Dallas

75701

Digestive Health Specialists of Tyler, Tyler

76008

Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk

76092

Texas Digestive Disease Consultants - Southlake, Southlake

77098

Gulf Coast Research Group LLC, Houston

78000

University Clinical Centre of the Republic of Srpska, Banja Luka

78229

Gastroenterology Research of San Antonio, LLC, San Antonio

78278

Barzilai Medical Center, Ashkelon

78550

Gastroenterology Consultants of South Texas, PA, Harlingen

79059

Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU, Lviv

79935

MedResearch, Inc, El Paso

80054

CHU Amiens - Hopital Sud, Amiens

80131

"Azienda Ospedaliera Universitaria Federico II", Napoli

Seconda Universita degli Studi di Napoli, Napoli

81108

IBDcentrum s.r.o., Bratislava

82606

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov, Bratislava

85037

Arizona Arthritis & Rheumatology Research, PLLC, Phoenix

85925

Centre Hospitalier Departemental Les Oudairies, La Roche S/ Yon Cedex 9

88000

University Clinical Hospital Mostar, Mostar

88009

SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU, Uzhhorod

90127

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo

90146

Azienda Ospedaliera Vincenzo Cervello, Palermo

91031

Shaare Zedek Medical Center, Jerusalem

91324

California Medical Research Associates Inc., Northridge

91910

Sociedad de Metabolismo y Corazon S.C, Veracruz

92110

Hopital Beaujon, Clichy

92231

Klaipeda Republican Hospital, Public Institution, Klaipėda

92288

Klaipeda University Hospital, Public Institution, Klaipėda

92626

WCCT Global (PH 1 Unit), Costa Mesa

95100

Azienda Ospedaliera Ospedale Cannizzaro, Catania

95816

Sutter Institute for Medical Research, Sacramento

97225

The Oregon Clinic-West Hills Gastroenterology, Portland

98101

Virginia Mason Seattle Main Clinic, Seattle

98125

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina

98801

Wenatchee Valley Hospital & Clinics, Wenatchee

111123

Research Institute of Gastroenterology, Moscow

119333

"FSBIH Central Clinical Hospital of Russian Academy of Sciences", Moscow

123154

"FSBI State Scientific Centre of Coloproctology of the MoH of RF", Moscow

150062

"SBIH of Yaroslavl region Regional Clinical Hospital ", Yaroslavl

194044

"FSMEI HPE Military Medical Academy n.a. S.M.Kirovof Ministry of Defense of Russia", Saint Petersburg

195257

"SPb SBIH City Hospital of Saint Martyr Elizaveta", Saint Petersburg

196247

"SPb SBIH City Hospital # 26", Saint Petersburg

197110

"SPb SBIH City Hospital # 9", Saint Petersburg

197706

"SPb SBIH City Hospital # 40 of Kurortnyi region", Sestroretsk

214019

"RSBIH Smolensk Regional Clinical Hospital", Smolensk

300002

S.C Centrul de Gastroenterologie Dr. Goldis S.R.L, Timișoara

344022

"SBEI HPE Rostov State Medical University of the MoH of the RF", Rostov-on-Don

410053

"SIH Regional Clinical Hospital ", Saratov

420012

"SBEI HPE Kazan State Medical University of the MoH of the RF", Kazan'

443115

"Private Educational Institution of Higher Education Medical University REAVIZ", Samara

603126

"SBIH of Nizhniy Novgorod region Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko", Nizhny Novgorod

630091

SBEIHPE Novosibirsk State Medical University, Novosibirsk

630117

"FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS", Novosibirsk

644013

BHI of Omsk region Clinical Oncology Dispensary, Omsk

644099

"SBEI of HPE Omsk SMA SBEI HPE Omsk State Medical University of the MoH of the RF", Omsk

660022

"TSBIH Territorial Clinical Hospital", Krasnoyarsk

681004

Fundacion Oftalmologica de Santander - FOSCAL, Floridablanca

3810101

Hillel Yaffe Medical, Hadera

4428164

Meir Medical Center, Kfar Saba

5265601

Chaim Sheba Medical Center, Ramat Gan

7610001

Kaplan Medical Center, Rehovot

9362410

Clalit Health Services-Lev Talpiyot, Jerusalem

80214-5434

Rocky Mountain Gastroenterology, Lakewood

06518

Medical Research Center of Connecticut, LLC, Hamden

33773-1615

Florida Center for Gastroenterology, Largo

08234

AGA Clinical Research Associates, LLC, Egg Harbor

27599-7080

University of North Carolina at Chapel Hill, Chapel Hill

37212-1375

Vanderbilt University Medical Center, Nashville

B7600FZ

Instituto de Investigaciones Clinicas-Mar del Plata, Mar del Plata

B1878DVB

Instituto Medico CER, Quilmes

C1128AAE

Expertia S.A- Mautalen Salud e Investigacion, Ciudad Autonoma Buenos Aires

X5000EVQ

Centro de Investigaciones Clinicas Instituto del Corazon, Córdoba

T6G 2X8

University of Alberta, Edmonton

L8N3Z5

McMaster University Health Sciences Center, Hamilton

K7L 5G2

Hotel Dieu Hospital, Kingston

N6A 5A5

LHSC - University Hospital, London

N6A 5W9

LHSC - Victoria Hospital, London

L4L 4Y7

Toronto Digestive Disease Associates, Inc., Vaughan

S7N 0W8

Royal University Hospital, Saskatoon

050025

Instituto de Coloproctologia ICO S.A.S., Medellín

500 12

Hepato-Gastroenterologie HK, s.r.o., Hradec Králové

530 02

CCBR Czech, a.s, Pardubice

182 00

Axon Clinical, s.r.o., Prague

140 59

Thomayerova nemocnice, Praha 4 - Krc

06200

CHU Nice - Hopital de l'Archet 2, Nice

04103

EUGASTRO GmbH, Leipzig

141 63

Krankenhaus Waldfriede e. V., Berlin

Unknown

The University of Hong Kong, Hong Kong

00000

Tuen Mun Hospital, Medicine & Geriatrics

The Chinese University of Hong Kong, Shatin

00152

Azienda Ospedaliera San Camillo Forlanini, Roma

LV-1006

"Digestive Diseases Center Gastro", Riga

LV1002

Pauls Stradins Clinical University Hospital SLLC, Riga

LT-08661

Vilnius University Hospital Santariskiu Clinic, Public Institution, Vilnius

1091 AC

Onze Lieve Vrouwe Gasthuis, Locatie Oost, Amsterdam

1105 AZ

Academisch Medisch Centrum, Amsterdam

9713 GZ

Universitair Medisch Centrum Groningen (UMCG), Groningen

6202 AZ

Maastricht University Medical Center, Maastricht

3015 CE

Erasmus Medisch Centrum, Rotterdam

15-275

SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego, Bialystok

85-079

NZOZ Vitamed, Bydgoszcz

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

40-752

SP CSK im. prof. K. Gibinskiego SUM, Katowice

31-009

Gabinet Endoskopii Przewodu Pokarmowego, Krakow

90-153

SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM, Lodz

90-302

Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz

20-582

GASTROMED Sp. z o.o., Lublin

60-529

SOLUMED Centrum Medyczne, Poznan

71-434

Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin

00-632

Centrum Zdrowia Matki, Dziecka i Mlodziezy, Warsaw

02-507

Centralny Szpital Kliniczny MSW w Warszawie, Warsaw

02-781

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warsaw

03-580

Nzoz Vivamed, Warsaw

53-114

LexMedica Osrodek Badan Klinicznych, Wroclaw

53-333

Ars-Medica S.C Rybak Maria, Rybak Zbigniew, Wroclaw

54-144

EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu, Wroclaw

4710-243

Hospital de Braga, Braga

3000-075

Centro Hospitalar e Universitario de Coimbra E.P.E, Coimbra

6200-502

Centro Hospitalar Cova da Beira, Covilha

4835-044

Hospital da Senhora da Oliveira Guimaraes, Guimarães

4904-858

Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE, Viana do Castelo

4434-502

Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E, Vila Nova de Gaia

020125

Spitalul Clinic Colentina, Bucharest

022328

Institutul Clinic Fundeni, Bucharest

04001

Gastroped s.r.o., Košice

949 01

KM Management spol. s r.o., Nitra

080 01

Gastro I, s.r.o., Prešov

936 01

Frantisek Horvath- GEA, Šahy

700-721

Kyungpook National University Hospital, Daegu

02447

Kyung Hee University Hospital, Seoul

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital, Yonsei University, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea, Seoul St. Marys Hospital, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

03010

Hospital General Universitario de Alicante, Alicante

06100

Ankara University Medical Faculty, Ankara

01023

CI of Kyiv RC Kyiv Regional Clinical Hospital, Kyiv

MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE, Kyiv

01103

Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU, Kyiv

04201

Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE, Kyiv

PL6 5FP

Derriford Hospital, Plymouth

M6 8HD

Salford Royal, Salford

NR47UY

Norfolk and Norwich University Hospital, Norwich

G4 0SF

Glasgow Royal Infirmary, Glasgow

CV2 2DX

University Hospital Coventry, Coventry

WV10 0QP

Royal Wolverhampton hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY