Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

383

Participants

Timeline

Start Date

December 18, 2015

Primary Completion Date

May 30, 2018

Study Completion Date

August 21, 2018

Conditions
Colitis, Ulcerative
Interventions
DRUG

Vedolizumab 300 mg IV

Vedolizumab intravenous infusion

DRUG

Placebo IV

Vedolizumab intravenous infusion placebo

DRUG

Vedolizumab 108 mg SC

Vedolizumab subcutaneous injection

DRUG

Placebo SC

Vedolizumab subcutaneous injection placebo

Trial Locations (174)

1036

Obudai Egeszsegugyi Centrum Kft., Budapest

1125

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Budapest

1202

Second MHAT - Sofia AD, Sofia

1340

Clinique Saint-Pierre, Ottignies

1407

"City Clinic UMHAC EOOD", Sofia

1431

"UMHAT Sv. Ivan Rilski, EAD", Sofia

1527

UMHAT 'Tsaritsa Yoanna - ISUL', EAD, Sofia

2139

Concord Repatriation General Hospital, Concord

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

2747

Nepean Hospital, Kingswood

3181

The Alfred Hospital, Melbourne

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

Odense Universitetshospital, Odense C

5800

MHAT 'Avis Medica' OOD, Pleven

6000

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

7100

Tolna Megyei Balassa Janos Korhaz, Szekszárd

7500

MHAT - Silistra AD, Silistra

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8800

AZ Delta, Roeselare

"MHAT Hadzhi Dimitar, OOD", Sliven

10000

Clinical Hospital Centre Zagreb, Zagreb

Clinical Hospital Dubrava, Zagreb

10617

West Tallinn Central Hospital, Tallinn

11000

Clinical Center Zvezdara, Belgrade

11021

Long Island Clinical Research Associates, Great Neck

11080

Clinical Center Bezanijska kosa, Belgrade

Clinical Center Zemun, Belgrade

12601

Premier Medical Group of the Hudson Valley, PC, Poughkeepsie

13000

Ccbr-Synarc A/S, Prague

14163

Krankenhaus Waldfriede e. V., Berlin

17176

Karolinska Universitetssjukhuset - Solna, Stockholm

18288

Danderyds Sjukhus AB, Stockholm

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

Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research, Chevy Chase

21000

Clinical Center of Vojvodina, Novi Sad

21001

Private Small Enterprise Medical Center Pulse, Vinnytsia

21029

MCIC MC LLC Health Clinic, Vinnytsia

23320

Gastroenterology Associates of Tidewater, Chesapeake

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

30024

Atlanta Gastroenterology Specialists, PC, Suwanee

30342

Atlanta Gastroenterology Associates, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31000

Clinical Hospital Centre Osijek, Osijek

31200

A-SHINE s.r.o., Pilsen

31201

Gastroenterology Associates of Central Georgia, Macon

32789

Shafran Gastroenterology Center, Winter Park

33176

L & L Research Choices, Inc., Miami

33777

Florida Center for Gastroenterology, Largo

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

34899

Marmara University Pendik Research and Training Hospital, Istanbul

35128

Azienda Ospedaliera di Padova, Padua

36164

Complejo Hospitalario de Pontevedra, Pontevedra

37000

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

37232

Vanderbilt University Medical Center, Nashville

38138

Gastro One, Germantown

41017

Tri-State Gastroenterology Associates, Crestview Hills

41944

Kyungpook National University Hospital, Daegu

42303

Research Concierge, LLC, Owensboro

42415

Yeungnam University Hospital, Daegu

45030

iBiomed Guadalajara, Zapopan

45415

Dayton Gastroenterology, Inc, Dayton

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

49074

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

49519

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

50009

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

51000

Clinical Hospital Centre Rijeka, Rijeka

52621

Chaim Sheba Medical Center, Ramat Gan

58002

RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU, Chernivtsi

58100

Wolfson Medical Center, Holon

60200

Ccbr-Synarc A/S, Brno

61037

CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2, Kharkiv

61039

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine, Kharkiv

64012

Ehrhardt Clinical Research, LLC, Belton

64460

Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey

64908

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

65025

CI Odesa Regional Clinical Hospital, Odesa

66606

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

69104

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

70809

Gastroenterology Associates, LLC, Baton Rouge

71013

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

72204

Arkansas Primary Care Clinic, PA, Little Rock

73000

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

74104

Options Health Research, Tulsa

75701

Tyler Research Institute, LLC, Tyler

76008

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

78000

University Clinical Centre of the Republic of Srpska, Banja Luka

80033

Rocky Mountain Clinical Research, LLC, Wheat Ridge

82606

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov, Bratislava

88009

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

91910

Sociedad de Metabolismo y Corazon S.C, Veracruz

92231

Klaipeda Republican Hospital, Public Institution, Klaipėda

98101

Virginia Mason Seattle Main Clinic, Seattle

119333

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

150062

"SBIH of Yaroslavl region Regional Clinical Hospital ", Yaroslavl

195257

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

197373

"LLC RIAT SPb", Saint Petersburg

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

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

660022

"TSBIH Territorial Clinical Hospital", Krasnoyarsk

06457

Middlesex Gastroenterology Associates, Middletown

C1128AAE

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

74535-170

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda, Goiânia

21941-913

HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro, Rio de Janeiro

18618-970

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu, Botucatu

09060-650

Faculdade de Medicina do ABC, Santo André

N6A 5A5

London Health Science Centre, London

N6A 5W9

LHSC - Victoria Hospital, London

L4L 4Y7

Toronto Digestive Disease Associates, Inc., Vaughan

500 12

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

182 00

Axon Clinical, s.r.o., Prague

04103

EUGASTRO GmbH, Leipzig

H-9200

Karolina Korhaz-Rendelointezet, Mosonmagyaróvár

00152

Azienda Ospedaliera San Camillo Forlanini, Roma

00168

Policlinico Universitario Agostino Gemelli, Roma

Unknown

Nagoya

Sakura-shi

Matsuyama

Chikushino-shi

Hiroshima

Sapporo

Nishinomiya-shi

Takamatsu

Kamakura-shi

Okayama

Osaka

Saga

Ōtsu

Hamamatsu

Bunkyō City

Minatoku

Mitaka-shi

Shinjuku-ku

Wakayama

LT-08661

Vilnius University Hospital Santariskiu Clinic, Public Institution, Vilnius

1105 AZ

Academisch Medisch Centrum, Amsterdam

3318 AT

Albert Schweitzer Ziekenhuis, Dordwijk, Dordrecht

6229 HX

Maastricht University Medical Center, Maastricht

15-275

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

85-079

NZOZ Vitamed, Bydgoszcz

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

71-270

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

020125

Spitalul Clinic Colentina, Bucharest

022328

Institutul Clinic Fundeni, Bucharest

949 01

KM Management spol. s r.o., Nitra

080 01

Gastro I, s.r.o., Prešov

02447

Kyung Hee University Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

06100

Ankara University Medical Faculty, Ankara

01103

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

01601

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

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

E11 1NR

Whipps Cross University Hospital, London

NW3 2QG

Royal Free Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY