Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

PHASE3CompletedINTERVENTIONAL
Enrollment

644

Participants

Timeline

Start Date

January 4, 2016

Primary Completion Date

May 6, 2019

Study Completion Date

August 6, 2019

Conditions
Crohn's Disease
Interventions
DRUG

Vedolizumab SC 108 mg

Vedolizumab SC Injection.

DRUG

Placebo

Vedolizumab placebo-matching SC injection.

DRUG

Vedolizumab IV 300 mg

Vedolizumab IV Injection.

Trial Locations (194)

100

Mackay Memorial Hospital, Taipei

1036

Obudai Egeszsegugyi Centrum Kft., Budapest

1088

Semmelweis Egyetem, Budapest

1125

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Budapest

1136

Pannonia Maganorvosi Centrum, Budapest

1407

"City Clinic UMHAC EOOD", Sofia

1431

"UMHAT Sv. Ivan Rilski, EAD", Sofia

1527

UMHAT 'Tsaritsa Yoanna - ISUL', EAD, Sofia

1606

Fourth MHAT - Sofia EAD, 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

3181

The Alfred Hospital, Melbourne

3350

Ballarat Base Hospital, Ballarat

3526

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

5000

Royal Adelaide Hospital, Adelaide

Odense Universitetshospital, Odense C

5042

Tennyson Centre Day Hospital, Bedford Park

6008

St John of God Subiaco Hospital, Subiaco

6150

Fiona Stanley Hospital, Murdoch

7100

Tolna Megyei Balassa Janos Korhaz, Szekszárd

7708

Dr JP Wright Practice, Cape Town

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8500

AZ Groeninge - Kennedylaan, Kortrijk

8600

Regionshospitalet Silkeborg, Silkeborg

8800

AZ Delta, Roeselare

"MHAT Hadzhi Dimitar, OOD", Sliven

9000

Universitair Ziekenhuis Gent, Ghent

11000

Clinical Helth Centre Zvezdara, Belgrade

Military Medical Academy, Belgrade

11021

Medical Research Center of Connecticut, LLC, Hamden

11080

Clinical Center Bezanijska kosa, Belgrade

11490

Karolinska Universitetssjukhuset - Solna, Stockholm

13000

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

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

18101

HaEmek Medical Center, Afula

20097

I.R.C.C.S Policlinico San Donato, San Donato Milanese (MI)

20157

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

21000

Clinical Center of Vojvodina, Novi Sad

21001

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

21005

RCI Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU, Chernivtsi

21009

CI Odesa Regional Clinical Hospital, Odesa

30024

Mayo Clinic - Rochester, Rochester

30342

Gastroenterology Group of Naples, Naples

30625

Medizinische Hochschule Hannover, Hanover

31200

A-SHINE s.r.o., Pilsen

31201

St George's Hospital, London

32789

Louisiana Research Center, LLC, Shreveport

33028

Rush University Medical Center, Chicago

33176

Atlanta Gastroenterology Associates, Atlanta

33343

Marmara University Pendik Research and Training Hospital, Istanbul

34000

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

Clinical Center Kragujevac, Kragujevac

34098

Mersin University Medical Faculty, Mersin

34102

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

34452

Royal Shrewsbury Hospital, Shrewsbury

34668

Kocaeli Derince Training and Research Hospital, Kocaeli

35128

Azienda Ospedaliera di Padova, Padua

37000

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

37520

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

39581

Gastro-Enterology Research of Lima, Lima

40138

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna

41017

University of North Carolina at Chapel Hill, Chapel Hill

41124

A.O.U. Policlinico di Modena, Modena

41380

Ankara University Medical Faculty, Ankara

41944

Kyungpook National University Hospital, Daegu

42415

Yeungnam University Hospital, Daegu

45806

Arizona Arthritis & Rheumatology Research, PLLC, Phoenix

46002

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

48047

Atlanta Gastroenterology Specialists, PC, Suwanee

49074

CI of Kyiv RC Kyiv Regional Clinical Hospital, Kyiv

49519

Clinical Research Institute of Michigan, LLC, Chesterfield

50009

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

53226

Gastroenterology Associates of Central Georgia, Macon

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

55905

Nature Coast Clinical Research, LLC, Inverness

58002

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

60200

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

60612

Ehrhardt Clinical Research, LLC, Belton

61801

Vanderbilt University Medical Center, Nashville

64012

Allegiance Research Specialists, LLC, Milwaukee

65025

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

69104

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

70809

Shafran Gastroenterology Center, Winter Park

71013

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

71105

Long Island Clinical Research Associates, Great Neck

73000

MCIC MC LLC Health Clinic, Vinnytsia

74104

Carle Foundation Hospital, Urbana

78000

University Clinical Centre of the Republic of Srpska, Banja Luka

78212

Gastroenterology Center of the MidSouth PC, Germantown

79059

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

82606

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov, Bratislava

83404

Options Health Research, Tulsa

85307

Gastroenterology Associates, LLC, Baton Rouge

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

95100

Azienda Ospedaliera Ospedale Cannizzaro, Catania

97517

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

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

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'

630091

SBEIHPE Novosibirsk State Medical University, Novosibirsk

630117

"FSBSI Scientific and Research Institute of Physiology and Basic Medicine", 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

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

Unknown

Middlesex Gastroenterology Associates, Middletown

L & L Research Choices, Inc., Miami

Grand Teton Research Group, PLL, Idaho Falls

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

San Antonio Gastroenterology, San Antonio

06518

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

06457

Tri-State Gastroenterology Associates, Crestview Hills

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

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

04103

EUGASTRO GmbH, Leipzig

H-9200

Karolina Korhaz-Rendelointezet, Mosonmagyaróvár

00152

Azienda Ospedaliera San Camillo Forlanini, Roma

00168

Policlinico Universitario Agostino Gemelli, Roma

285-8741

Toho University Sakura Medical Center, Sakura-shi

818-8502

Fukuoka University Chikushi Hospital, Chikushino-shi

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

247-0056

Gokeikai Ofuna Chuo Hospital, Kamakura-shi

530-0011

Kinshukai Infusion Clinic, Osaka

849-8501

Saga University Hospital, Saga

430-0846

Hamamatsu South Hospital, Hamamatsu

108-8642

Kitasato University Kitasato Institute Hospital, Minatoku

169-0073

JCHO Tokyo Yamate Medical Center, Shinjuku-ku

641-8510

Wakayama Medical University Hospital, Wakayama

LT-08661

Vilnius University Hospital Santariskiu Clinic, Public Institution, Vilnius

1105 AZ

Academisch Medisch Centrum, Amsterdam

3318 AT

Albert Schweitzer Ziekenhuis, Dordwijk, Dordrecht

3015 CE

Erasmus Medisch Centrum, Rotterdam

85-079

NZOZ Vitamed, Bydgoszcz

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

00-635

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

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

01023

Haydarpasa Numune Training and Research Hospital, Istanbul

Private Small Enterprise Medical Center Pulse, Vinnytsia

01103

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

CV2 2DX

Ternopil University Hospital, Ternopil

EX2 5DW

CI City Hospital #1, Zaporizhzhia

SY3 8XQ

Royal Devon and Exeter Hospital (Wonford), Exeter

SW170QT

Whipps Cross University Hospital, London

NW3 2QG

University Hospital Coventry, Coventry

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY

NCT02611817 - Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD) | Biotech Hunter | Biotech Hunter