A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

746

Participants

Timeline

Start Date

April 15, 2016

Primary Completion Date

June 12, 2024

Study Completion Date

June 12, 2024

Conditions
Colitis, UlcerativeCrohn's Disease
Interventions
DRUG

Vedolizumab SC

Vedolizumab SC 108 mg injection

Trial Locations (301)

100

National Taiwan University Hospital, Taipei

1023

CI of Kyiv RC Kyiv Regional Clinical Hospital, Kyiv

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

1036

Obudai Egeszsegugyi Centrum Kft., Budapest

1088

Semmelweis Egyetem, Budapest

1103

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

1125

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Budapest

1136

Pannonia Maganorvosi Centrum, Budapest

1202

Second MHAT - Sofia AD, Sofia

1340

Clinique Saint-Pierre, Ottignies

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

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

2170

ZNA Jan Palfijn, Merksem

2747

Nepean Hospital, Kingswood

2820

Imeldaziekenhuis, Bonheiden

3000

Royal Melbourne Hospital, Melbourne

3065

St Vincent's Hospital Melbourne, Fitzroy

3144

St Frances Xavier Cabrini Hospital, Malvern

3165

Monash Medical Centre Clayton, Bentleigh East

3181

The Alfred Hospital, Melbourne

3300

Markhot Ferenc Oktatokorhaz es Rendelointezet, Eger

3350

Ballarat Base Hospital, Ballarat

3526

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Miskolc

4101

Mater Hospital Brisbane, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

Odense Universitetshospital, Odense C

5037

Tennyson Centre Day Hospital, Kurralta Park

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula

5800

"MHAT Avis - Medica OOD", Pleven

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

6000

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

6008

St John of God Subiaco Hospital, Subiaco

6150

Fiona Stanley Hospital, Murdoch

7100

Tolna Megyei Balassa Janos Korhaz, Szekszárd

7500

MHAT - Silistra AD, Silistra

Dr MJ Prins Practice, Cape Town

7624

Pecsi Tudomanyegyetem, Pécs

7708

Dr JP Wright Practice, Cape Town

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8310

AZ Sint-Lucas, Bruges

8500

AZ Groeninge - Kennedylaan, Kortrijk

8600

Regionshospitalet Silkeborg, Silkeborg

8800

AZ Delta, Roeselare

"MC Tsaritsa Yoanna' EOOD", Sliven

"MHAT Hadzhi Dimitar, OOD", Sliven

9000

Universitair Ziekenhuis Gent, Ghent

10000

Clinical Hospital Dubrava, Zagreb

University hospital centre Zagreb, Zagreb

10449

Mackay Memorial Hospital, Taipei

10617

West Tallinn Central Hospital, Tallinn

11000

Clinical Center of Serbia, Belgrade

Clinical Helth Centre Zvezdara, Belgrade

Military Medical Academy, Belgrade

11021

Long Island Clinical Research Associates, Great Neck

11080

Clinical Center Bezanijska Kosa, Belgrade

Clinical Center Zemun, Belgrade

11490

Tri-Service General Hospital, Taipei

12601

Premier Medical Group of the Hudson Valley, PC, Poughkeepsie

13000

CCBR Czech Prague, s.r.o., Prague

13353

Charite - Campus Virchow-Klinikum, Berlin

13419

North Estonia Medical Centre Foundation, Tallinn

14050

DRK Kliniken Berlin Westend, Berlin

14163

Krankenhaus Waldfriede e. V., Berlin

15000

Axon Clinical s.r.o., Prague

17007

Hospital Universitari de Girona Dr Josep Trueta, Girona

18000

Clinical Center Nis, Niš

18101

HaEmek Medical Center, Afula

18944

Main Line Gastroenterology Associates, Perkasie

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

21005

Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU, Vinnytsia

21009

MCIC MC LLC Health Clinic, Vinnytsia

23320

Gastroenterology Associates of Tidewater, Chesapeake

23538

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck, Lübeck

24105

Universitaetsklinikum Schleswig-Holstein - Campus Kiel, Kiel

27599

University of North Carolina at Chapel Hill, Chapel Hill

28034

Hospital Universitario Ramon y Cajal, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

29425

Medical University of South Carolina (MUSC), Charleston

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

33028

BRCR Medical Center, Inc., Pembroke Pines

33176

L & L Research Choices, Inc., Miami

33343

Mersin University Medical Faculty, Mersin

33542

Florida Medical Clinic, P.A., Zephyrhills

33777

Florida Center for Gastroenterology, Largo

34000

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

Clinical Center Kragujevac, Kragujevac

34098

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul

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

36164

Complejo Hospitalario de Pontevedra, Pontevedra

37000

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

37232

Vanderbilt University Medical Center, Nashville

37520

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

38138

Gastroenterology Center of the MidSouth PC, Germantown

39001

Nemocnice Tabor a.s., Tábor

39120

Universitaetsklinikum Magdeburg A.oe.R, Magdeburg

39564

Digestive Health Center PA, Ocean Springs

40138

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna

41017

Tri-State Gastroenterology Associates, Crestview Hills

41124

A.O.U. Policlinico di Modena, Modena

41380

Kocaeli Derince Training and Research Hospital, Kocaeli

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

45806

Gastro-Enterology Research of Lima, Lima

46002

Ternopil University Hospital, Ternopil

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48197

Huron Gastroenterology Associates, Ypsilanti

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

50406

Tartu University Hospital, Tartu

50937

Universitaetsklinikum Koeln, Cologne

51000

Clinical Hospital Centre Rijeka, Rijeka

Special Hospital Medico, Rijeka

53226

Allegiance Research Specialists, LLC, Milwaukee

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

55905

Mayo Clinic - Rochester, Rochester

58002

RCNECRCH Dept of Surgery, SHEI Ukr BSMU, Chernivtsi

58100

Wolfson Medical Center, Holon

60200

CCBR - Czech Brno, s.r.o.., Brno

60590

Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt am Main

60612

Rush University Medical Center, Chicago

61037

CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC, Kharkiv

61801

Carle Foundation Hospital, Urbana

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

69014

CI City Hospital #1, Zaporizhzhia

70503

Lafayette General Medical Center, Lafayette

70809

Gastroenterology Associates, LLC, Baton Rouge

71013

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

71103

Louisiana Research Center, LLC, Shreveport

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

78212

San Antonio Gastroenterology, San Antonio

78278

Barzilai Medical Center, Ashkelon

79059

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

80033

Rocky Mountain Clinical Research, LLC, Wheat Ridge

80131

"Azienda Ospedaliera Universitaria Federico II", Napoli

81377

LMU - Campus Grosshadern, Munich

82606

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov, Bratislava

83404

Grand Teton Research Group, PLL, Idaho Falls

85307

Arizona Arthritis & Rheumatology Research, PLLC, Phoenix

88000

University Clinical Hospital Mostar, Mostar

90146

Azienda Ospedaliera Vincenzo Cervello, Palermo

91031

Shaare Zedek Medical Center, Jerusalem

91910

Sociedad de Metabolismo y Corazon S.C, Veracruz

92231

Klaipeda Republican Hospital, Public Institution, Klaipėda

92288

Klaipeda University Hospital, Public Institution, Klaipėda

95100

Azienda Ospedaliera Ospedale Cannizzaro, Catania

97517

Fakultna nemocnica s poliklinikou F.D. Roosevelta, Banská Bystrica

98101

Virginia Mason Seattle Main Clinic, Seattle

98125

Azienda Ospedaliera Universitaria Policlinico G. Martino, Messina

119333

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

195257

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

197373

"LLC RIAT SPb", Saint Petersburg

197706

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

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

420012

Kazan State Medical University, Kazan'

630007

"LLC Novosibirsk GastroCenter", Novosibirsk

630091

SBEIHPE Novosibirsk State Medical University, Novosibirsk

644013

"BHI of Omsk region Clinical Oncology Dispensary", Omsk

660022

"TSBIH Territorial Clinical Hospital", Krasnoyarsk

2210001

Galilee Medical Center, Nahariya

3109601

Rambam Health Care Campus, Haifa

5265601

Chaim Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

7610001

Kaplan Medical Center, Rehovot

8410101

Soroka University Medical Center, Beersheba

06518

Medical Research Center of Connecticut, LLC, Hamden

06457

Middlesex Gastroenterology Associates, Middletown

08234

AGA Clinical Research Associates, LLC, Egg Harbor

C1181ACH

Hospital Italiano, Ciudad Autonoma Buenos Aires

B7600FYK

Centro de Investigaciones Medicas Mar del Plata, Mar del Plata

C1120AAC

Centro Medico Viamonte SRL, Buenos Aires

74535-170

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda, Goiânia

20270-004

HUGG - Hospital Universitario Gaffree e Guinle, Rio de Janeiro

21941-913

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

99010-080

Hospital Sao Vicente de Paulo, Passo Fundo

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

18618-970

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

09060-650

Faculdade de Medicina do ABC, Santo André

11075-900

Irmandade da Santa Casa da Misericordia de Santos, Santos

15090-000

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, São José do Rio Preto

T6G 2X8

Zeidler Ledcor Centre - University of Alberta, Edmonton

V8V 3M9

PerCuro Clinical Research Ltd., Victoria

N6A 5A5

LHSC - University Hospital, 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

100 00

CLINTRIAL 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

460-0022

Yokoyama IBD Clinic, Nagoya

285-8741

Toho University Sakura Medical Center, Sakura-shi

790-0024

Ehime Prefectural Central Hospital, Matsuyama

818-8502

Fukuoka University Chikushi Hospital, Chikushino-shi

814-0180

Fukuoka University Hospital, Fukuoka

830-0011

Kurume University Hospital, Kurume-shi

734-8551

Hiroshima University Hospital, Hiroshima

004-0041

Tokushukai Sapporo Tokushukai Hospital, Sapporo

060-0033

Sapporo-Kosei General Hospital, Sapporo

065-0033

Tokushukai Sapporo Higashi Tokushukai Hospital, Sapporo

663-8501

Hyogo College of Medicine Hospital, Nishinomiya-shi

020-8505

Iwate Medical University Hospital, Morioka

760-8557

Kagawa Prefectural Central Hospital, Takamatsu

247-0056

Gokeikai Ofuna Chuo Hospital, Kamakura-shi

700-8558

Okayama University Hospital, Okayama

530-0011

Kinshukai Infusion Clinic, Osaka

534-0021

Osaka City General Hospital, Osaka

849-8501

Saga University Hospital, Saga

520-2192

Shiga University of Medical Science Hospital, Ōtsu

430-0846

Hamamatsu South Hospital, Hamamatsu

113-8519

Medical Hospital, Tokyo Medical and Dental University, Bunkyō City

105-8471

Jikei University Hospital, Minatoku

108-8642

Kitasato University Kitasato Institute Hospital, Minatoku

181-8611

Kyorin University Hospital, Mitaka-shi

160-8582

Keio University Hospital, Shinjuku-ku

169-0073

JCHO Tokyo Yamate Medical Center, Shinjuku-ku

641-8510

Wakayama Medical University Hospital, Wakayama

LT-08661

Vilnius University Hospital Santariskiu Clinics, Public Institution, Vilnius

1105 AZ

Academisch Medisch Centrum, Amsterdam

3317 NM

Albert Schweitzer Ziekenhuis, Dordrecht

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

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

71-434

Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin

00-632

Centrum Zdrowia MDM, 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

04001

Gastroped s.r.o., Košice

949 01

KM Management spol. s r.o., Nitra

080 01

Gastro I, s.r.o., Prešov

0181

Dr CCM Ziady Practice, Pretoria

02447

Kyung Hee University 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

08916

Hospital Universitari Germans Trias i Pujol, Badalona

03010

Hospital General Universitario de Alicante, Alicante

171 76

Karolinska Universitetssjukhuset - Solna, Stockholm

182 88

Danderyds Sjukhus, Stockholm

06100

Ankara University Medical Faculty, Ankara

06500

Gazi University Medical Faculty, Ankara

EX2 5DW

Royal Devon and Exeter Hospital (Wonford), Exeter

E11 1NR

Whipps Cross University Hospital, London

NW3 2QG

Royal Free Hospital, London

SW170QT

St George's Hospital, London

NR47UY

Norfolk and Norwich University Hospital, Norwich

SY3 8XQ

Royal Shrewsbury Hospital, Shrewsbury

CV2 2DX

University Hospital Coventry, Coventry

WV10 0QP

Royal Wolverhampton hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY