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

January 14, 2020 updated by: Takeda

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

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.

Study Overview

Status

Completed

Conditions

Colitis, Ulcerative

Intervention / Treatment

Detailed Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.

The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

Vedolizumab 300 mg IV
Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC

All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.

Study Type

Interventional

Enrollment (Actual)

771

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Ciudad Autonoma Buenos Aires, Argentina, C1128AAE
    - Expertia S.A- Mautalen Salud e Investigación
  - Cordoba, Argentina, X5000EVQ
    - Centro de Investigaciones Clinicas Instituto del Corazon
- Buenos Aires
  - Mar del Plata, Buenos Aires, Argentina, B7600FZ
    - Instituto de Investigaciones Clinicas-Mar del Plata
  - Quilmes, Buenos Aires, Argentina, B1878DVB
    - Instituto Medico CER
Australia
- New South Wales
  - Concord, New South Wales, Australia, 2139
    - Concord Repatriation General Hospital
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Mater Adult Hospital
  - Woolloongabba, Queensland, Australia, 4102
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Royal Adelaide Hospital
  - Bedford Park, South Australia, Australia, 5042
    - Tennyson Centre Day Hospital
- Victoria
  - Ballarat, Victoria, Australia, 3350
    - Ballarat Base Hospital
  - Clayton, Victoria, Australia, 3168
    - Monash Medical Centre Moorabbin
  - Malvern, Victoria, Australia, 3144
    - St Frances Xavier Cabrini Hospital
Belgium
- - Gent, Belgium, 9000
    - Universitair Ziekenhuis Gent
Bosnia and Herzegovina
- - Banja Luka, Bosnia and Herzegovina, 78000
    - University Clinical Centre of the Republic of Srpska
  - Mostar, Bosnia and Herzegovina, 88000
    - University Clinical Hospital Mostar
  - Sarajevo, Bosnia and Herzegovina, 71000
    - University Clinic Centre Sarajevo
Bulgaria
- - Pazardzhik, Bulgaria, 4400
    - MHAT - Pazardzhik AD
  - Pleven, Bulgaria, 5800
    - UMHAT 'Dr. Georgi Stranski', EAD
  - Pleven, Bulgaria, 5800
    - MHAT 'Avis Medica' OOD
  - Sliven, Bulgaria, 8800
    - MHAT "Hadzhi Dimitar", OOD
  - Sofia, Bulgaria, 1407
    - "City Clinic UMHAC" EOOD
  - Sofia, Bulgaria, 1431
    - UMHAT "Sv. Ivan Rilski", EAD
  - Sofia, Bulgaria, 1527
    - UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  - Sofia, Bulgaria, 1606
    - Fourth MHAT - Sofia EAD
  - Sofia, Bulgaria, 1407
    - Medical Center "Excelsior", OOD
  - Sofia, Bulgaria, 1750
    - UMHAT 'Sveta Anna' AD
  - Sofia, Bulgaria, 1606
    - Military Medical Academy - MHAT - Sofia
  - Stara Zagora, Bulgaria, 6000
    - Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  - Varna, Bulgaria, 9020
    - MHAT 'Sv. Marina', EAD
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 2X8
    - University of Alberta
- Ontario
  - Hamilton, Ontario, Canada, L8N3Z5
    - McMaster University Health Sciences Center
  - Kingston, Ontario, Canada, K7L 5G2
    - Hotel Dieu Hospital
  - London, Ontario, Canada, N6A 5A5
    - LHSC - University Hospital
  - London, Ontario, Canada, N6A 5W9
    - LHSC - Victoria Hospital
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Toronto Digestive Disease Associates, Inc.
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Royal University Hospital
Colombia
- - Floridablanca, Colombia, 681004
    - Fundacion Oftalmologica de Santander - FOSCAL
  - Medellin, Colombia, 050025
    - Instituto de Coloproctologia ICO S.A.S.
Croatia
- - Osijek, Croatia, 31000
    - Clinical Hospital Centre Osijek
  - Pula, Croatia, 52100
    - General Hospital Pula
  - Rijeka, Croatia, 51000
    - Polyclinic Medico
  - Zagreb, Croatia, 10000
    - Clinical Hospital Centre Zagreb
  - Zagreb, Croatia, 10000
    - Clinical Hospital Dubrava
  - Zagreb, Croatia, 10000
    - Clinical Hospital Merkur
  - Zagreb, Croatia, 10000
    - Clinical Hospital Center "Sestre Milosrdnice"
Czechia
- - Brno, Czechia, 65691
    - Fakultni nemocnice u sv. Anny v Brne
  - Brno, Czechia, 60200
    - CCBR - Brno - CZ
  - Hradec Kralove, Czechia, 500 12
    - Hepato-gastroenterologie HK, s.r.o.
  - Pardubice, Czechia, 530 02
    - CCBR Czech, a.s
  - Plzen, Czechia, 31200
    - A-Shine
  - Praha 3, Czechia, 13000
    - CCBR - Prague - CZ
  - Praha 4 - Krc, Czechia, 140 59
    - Thomayerova nemocnice
  - Praha 7, Czechia, 17004
    - Klinicke centrum ISCARE Lighthouse
  - Praha 8, Czechia, 182 00
    - Axon Clinical, s.r.o.
Denmark
- - Frederikssund, Denmark, 3600
    - Nordsjallands Hospital, Frederikssund
  - Hvidovre, Denmark, 2650
    - Hvidovre_Hospital
  - Koge, Denmark, 4600
    - Koge Sygehus
  - Odense C, Denmark, 5000
    - Odense Universitetshospital
Estonia
- - Tallinn, Estonia, 10617
    - West Tallinn Central Hospital
  - Tallinn, Estonia, 13419
    - North Estonia Medical Centre Foundation
  - Tartu, Estonia, 50406
    - Tartu University Hospital
France
- Alpes Maritimes
  - Nice Cedex 3, Alpes Maritimes, France, 06200
    - CHU Nice - Hopital de l'Archet 2
- Bouches-du-Rhone
  - Marseille, Bouches-du-Rhone, France, 13008
    - Hopital Saint Joseph
  - Marseille cedex 20, Bouches-du-Rhone, France, 13915
    - Hopital Nord - CHU Marseille
- Gironde
  - Pessac, Gironde, France, 33604
    - Groupe Hospitalier Sud - Hôpital Haut-Lévêque
- Haute Garonne
  - Toulouse Cedex 09, Haute Garonne, France, 31059
    - CHU de Toulouse - Hôpital Rangueil
- Hauts De Seine
  - Clichy cedex, Hauts De Seine, France, 92110
    - Hôpital Beaujon
- Loire
  - Saint Etienne, Loire, France, 42055
    - CHU Saint Etienne - Hôpital Nord
- Meurthe Et Moselle
  - Vandoeuvre les Nancy, Meurthe Et Moselle, France, 54511
    - Hôpital de Brabois Adultes
- Nord
  - Lille cedex, Nord, France, 59037
    - Hopital Claude Huriez - CHU Lille
- Somme
  - Amiens Cedex, Somme, France, 80054
    - CHU Amiens - Hopital Sud
- Vendee
  - La Roche S/ Yon Cedex 9, Vendee, France, 85925
    - Centre Hospitalier Departemental Les Oudairies
Germany
- - Berlin, Germany, 13353
    - Charite - Campus Virchow-Klinikum
  - Berlin, Germany, 141 63
    - Krankenhaus Waldfriede e. V.
  - Hamburg, Germany, 22559
    - Asklepios Klinik Hamburg
- Baden Wuerttemberg
  - Heidelberg, Baden Wuerttemberg, Germany, 69120
    - Universitaetsklinikum Heidelberg
  - Tuebingen, Baden Wuerttemberg, Germany, 72076
    - Universitaetsklinikum Tuebingen
- Hessen
  - Frankfurt, Hessen, Germany, 60590
    - Klinikum Der Johann Wolfgang Goethe-Universitaet
- Nordrhein Westfalen
  - Koeln, Nordrhein Westfalen, Germany, 50937
    - Universitaetsklinikum Koeln
- Rheinland Pfalz
  - Mainz, Rheinland Pfalz, Germany, 55131
    - Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
- Sachsen
  - Leipzig, Sachsen, Germany, 04103
    - Eugastro GmbH
- Sachsen Anhalt
  - Magdeburg, Sachsen Anhalt, Germany, 39120
    - Universitaetsklinikum Magdeburg A.oe.R
- Schleswig Holstein
  - Kiel, Schleswig Holstein, Germany, 24105
    - Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  - Lubeck, Schleswig Holstein, Germany, 23538
    - Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Hong Kong
- - Hong Kong, Hong Kong
    - The University of Hong Kong
  - Medicine & Geriatrics, Hong Kong, 00000
    - Tuen Mun Hospital
  - Shatin, Hong Kong, 00000
    - The Chinese University of Hong Kong
Hungary
- - Bekescsaba, Hungary, 5600
    - Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
  - Budapest, Hungary, 1083
    - Semmelweis Egyetem
  - Budapest, Hungary, 1088
    - Semmelweis Egyetem
  - Budapest, Hungary, 1136
    - Pannónia Magánorvosi Centrum
  - Budapest, Hungary, 1076
    - Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont
  - Eger, Hungary, 3300
    - Markhot Ferenc Oktatokorhaz es Rendelointezet
  - Pecs, Hungary, 7624
    - Pécsi Tudományegyetem
  - Szeged, Hungary, 6720
    - Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  - Szekszard, Hungary, 7100
    - Tolna Megyei Balassa János Kórház
Israel
- - Afula, Israel, 18101
    - Haemek Medical Center
  - Ashkelon, Israel, 78278
    - Barzilai Medical Center
  - Hadera, Israel, 3810101
    - Hillel Yaffe Medical
  - Holon, Israel, 58100
    - Wolfson Medical Center
  - Jerusalem, Israel, 91031
    - Shaare Zedek Medical Center
  - Jerusalem, Israel, 9362410
    - Clalit Health Services-Lev Talpiyot
  - Kfar- Saba, Israel, 4428164
    - Meir Medical Center
  - Nahariya, Israel, 22100
    - Galilee Medical Center
  - Ramat Gan, Israel, 5265601
    - Chaim Sheba Medical Center
  - Rechovot, Israel, 7610001
    - Kaplan Medical Center
  - Tel Aviv, Israel, 64239
    - Tel Aviv Sourasky Medical Center
Italy
- - Bologna, Italy, 40138
    - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  - Catania, Italy, 95100
    - Azienda Ospedaliera Ospedale Cannizzaro
  - Genova, Italy, 16132
    - Azienda Ospedaliero Universitaria San Martino
  - Messina, Italy, 98125
    - Azienda Ospedaliera Universitaria Policlinico G. Martino
  - Milano, Italy, 20157
    - Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  - Modena, Italy, 41124
    - A.O.U. Policlinico di Modena
  - Napoli, Italy, 80131
    - Azienda Ospedaliera Universitaria "Federico II"
  - Napoli, Italy, 80131
    - Seconda Università degli Studi di Napoli
  - Padova, Italy, 35128
    - Azienda Ospedaliera Di Padova
  - Palermo, Italy, 90146
    - Azienda Ospedaliera Vincenzo Cervello
  - Palermo, Italy, 90127
    - Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  - Pisa, Italy, 56124
    - Azienda Ospedaliero Universitaria Pisana
  - Roma, Italy, 00152
    - Azienda Ospedaliera San Camillo Forlanini
- Foggia
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - IRCCS Ospedale Casa Sollievo della Sofferenza
- Milano
  - Rozzano, Milano, Italy, 20089
    - Istituto Clinico Humanitas
  - San Donato Milanese, Milano, Italy, 20097
    - I.R.C.C.S Policlinico San Donato
Korea, Republic of
- - Busan, Korea, Republic of, 49241
    - Pusan National University Hospital
  - Daegu, Korea, Republic of, 42415
    - Yeungnam University Hospital
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 02447
    - Kyung Hee University Hospital
  - Seoul, Korea, Republic of, 02841
    - Korea University Anam Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 03181
    - Kangbuk Samsung Hospital
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital, Yonsei University
  - Seoul, Korea, Republic of, 06591
    - The Catholic University of Korea, Seoul St. Marys Hospital
- Gyeonggi-do
  - Guri-si, Gyeonggi-do, Korea, Republic of, 11923
    - Hanyang Univerisy Guri Hospital
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
  - Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
    - The Catholic university of Korea, St. Vincent's Hospital
- Gyeongsangbuk-do
  - Daegu, Gyeongsangbuk-do, Korea, Republic of, 700-721
    - Kyungpook National University Hospital
Latvia
- - Riga, Latvia, LV1002
    - Pauls Stradins Clinical University Hospital SLLC
  - Riga, Latvia, LV-1006
    - Digestive Diseases Center "Gastro"
Lithuania
- - Kaunas, Lithuania, 50009
    - Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  - Klaipeda, Lithuania, 92288
    - Klaipeda University Hospital, Public Institution
  - Klaipeda, Lithuania, 92231
    - Klaipeda Republican Hospital, Public Institution
  - Vilnius, Lithuania, LT-08661
    - Vilnius University Hospital Santariskiu Clinic, Public Institution
Mexico
- - Durango, Mexico, 34000
    - Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  - Veracruz, Mexico, 91910
    - Sociedad de Metabolismo y Corazon S.C
- Guanajuato
  - Leon, Guanajuato, Mexico, 37000
    - Morales Vargas Centro de Investigacion, S.C.
  - Leon, Guanajuato, Mexico, 37520
    - Centro de Investigacion Farmacologica del Bajío, S.C.
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64908
    - Christus Muguerza Sur S.A. de C.V.
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Academisch Medisch Centrum
  - Amsterdam, Netherlands, 1091 AC
    - Onze Lieve Vrouwe Gasthuis, locatie Oost
  - Groningen, Netherlands, 9713 GZ
    - Universitair Medisch Centrum Groningen (UMCG)
  - Maastricht, Netherlands, 6202 AZ
    - Maastricht University Medical Center
  - Rotterdam, Netherlands, 3015 CE
    - Erasmus Medisch Centrum
Poland
- - Bialystok, Poland, 15-275
    - SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  - Bydgoszcz, Poland, 85-079
    - NZOZ Vitamed
  - Gdansk, Poland, 80-952
    - Uniwersyteckie Centrum Kliniczne
  - Katowice, Poland, 40-752
    - SP CSK im. prof. K. Gibinskiego SUM
  - Krakow, Poland, 31-009
    - Gabinet Endoskopii Przewodu Pokarmowego
  - Lodz, Poland, 90-302
    - SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
  - Lodz, Poland, 90-153
    - SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
  - Lublin, Poland, 20-582
    - GASTROMED Sp. z o.o.
  - Poznan, Poland, 60-529
    - Solumed Centrum Medyczne
  - Szczecin, Poland, 71-434
    - Twoja Przychodnia-Szczecinskie Centrum Medyczne
  - Warszawa, Poland, 03-580
    - NZOZ Vivamed
  - Warszawa, Poland, 02-781
    - Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  - Warszawa, Poland, 02-507
    - Centralny Szpital Kliniczny MSW w Warszawie
  - Warszawa, Poland, 00-632
    - Centrum Zdrowia Matki, Dziecka i Mlodziezy
  - Wroclaw, Poland, 53-114
    - LexMedica Osrodek Badan Klinicznych
  - Wroclaw, Poland, 53-333
    - Ars-Medica S.C Rybak Maria, Rybak Zbigniew
  - Wroclaw, Poland, 54-144
    - EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga
  - Coimbra, Portugal, 3000-075
    - Centro Hospitalar e Universitario de Coimbra E.P.E
  - Covilha, Portugal, 6200-502
    - Centro Hospitalar Cova da Beira
  - Guimaraes, Portugal, 4835-044
    - Hospital Da Senhora Da Oliveira Guimarăes
  - Viana do Castelo, Portugal, 4904-858
    - Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
  - Vila Nova de Gaia, Portugal, 4434-502
    - Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Romania
- - Bucuresti, Romania, 020125
    - Spitalul Clinic Colentina
  - Bucuresti, Romania, 022328
    - Institutul Clinic Fundeni
  - Timisoara, Romania, 300002
    - S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Russian Federation
- - Kazan, Russian Federation, 420012
    - SBEI HPE "Kazan State Medical University" of the MoH of the RF
  - Krasnoyarsk, Russian Federation, 660022
    - TSBIH "Territorial Clinical Hospital"
  - Moscow, Russian Federation, 119333
    - FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
  - Moscow, Russian Federation, 111123
    - Research Institute of Gastroenterology
  - Moscow, Russian Federation, 123154
    - FSBI State Scientific Centre of Coloproctology" of the MoH of RF
  - Nizhny Novgorod, Russian Federation, 603126
    - SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
  - Novosibirsk, Russian Federation, 630091
    - SBEIHPE Novosibirsk State Medical University
  - Novosibirsk, Russian Federation, 630117
    - FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
  - Omsk, Russian Federation, 644013
    - BHI of Omsk region Clinical Oncology Dispensary
  - Omsk, Russian Federation, 644099
    - SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
  - Rostov-on-Don, Russian Federation, 344022
    - SBEI HPE "Rostov State Medical University" of the MoH of the RF
  - Saint-Petersburg, Russian Federation, 194044
    - FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
  - Saint-Petersburg, Russian Federation, 196247
    - SPb SBIH "City Hospital # 26"
  - Saint-Petersburg, Russian Federation, 197110
    - SPb SBIH "City Hospital # 9"
  - Samara, Russian Federation, 443115
    - Private Educational Institution of Higher Education "Medical University "REAVIZ"
  - Saratov, Russian Federation, 410053
    - SIH "Regional Clinical Hospital "
  - Sestroretsk, Russian Federation, 197706
    - SPb SBIH "City Hospital # 40 of Kurortnyi region"
  - Smolensk, Russian Federation, 214019
    - RSBIH "Smolensk Regional Clinical Hospital"
  - St. Petersburg, Russian Federation, 195257
    - SPb SBIH "City Hospital of Saint Martyr Elizaveta"
  - Yaroslavl, Russian Federation, 150062
    - SBIH of Yaroslavl region " Regional Clinical Hospital "
Serbia
- - Belgrade, Serbia, 11080
    - Clinical Center Bezanijska kosa
  - Belgrade, Serbia, 11000
    - Clinical Center of Serbia
  - Belgrade, Serbia, 11000
    - Clinical Center Zvezdara
  - Belgrade, Serbia, 11080
    - Clinical Center Zemun
  - Kragujevac, Serbia, 34000
    - Clinical Center Kragujevac
  - Nis, Serbia, 18000
    - Clinical Center Nis
  - Novi Sad, Serbia, 21000
    - Clinical Center of Vojvodina
Slovakia
- - Bratislava, Slovakia, 82606
    - Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  - Bratislava, Slovakia, 81108
    - IBDcentrum s.r.o.
  - Kosice, Slovakia, 04001
    - Gastroped s.r.o.
  - Nitra, Slovakia, 949 01
    - KM Management spol. s r.o.
  - Presov, Slovakia, 080 01
    - Gastro I, s.r.o.
  - Sahy, Slovakia, 936 01
    - Frantisek Horvath- GEA
Spain
- - Alicante, Spain, 03010
    - Hospital General Universitario de Alicante
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon y Cajal
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Hospital Universitari Germans Trias i Pujol
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro Majadahonda
Taiwan
- - Kaohsiung, Taiwan, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung, Taiwan, 402
    - Chung Shan Medical University Hospital
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taipei, Taiwan, 10449
    - Mackay Memorial Hospital
Turkey
- - Ankara, Turkey, 06100
    - Ankara University Medical Faculty
  - Istanbul, Turkey, 34349
    - Acibadem Fulya Hospital
  - Istanbul, Turkey, 34668
    - Haydarpasa Numune Training and Research Hospital
  - Istanbul, Turkey, 34899
    - Marmara University Pendik Research and Training Hospital
  - Kocaeli, Turkey, 41380
    - Kocaeli Derince Training and Research Hospital
  - Mersin, Turkey, 33343
    - Mersin University Medical Faculty
Ukraine
- - Chernivtsi, Ukraine, 58002
    - RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
  - Dnipropetrovsk, Ukraine, 49074
    - SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
  - Ivano-Frankivsk, Ukraine, 76008
    - Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
  - Kharkiv, Ukraine, 61037
    - CI of PH Kharkiv CCH #2
  - Kherson, Ukraine, 73000
    - CI A.and O. Tropiny City Clinical Hospital
  - Kirovohrad, Ukraine, 25006
    - Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
  - Kyiv, Ukraine, 04201
    - Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
  - Kyiv, Ukraine, 01103
    - Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  - Kyiv, Ukraine, 01023
    - CI of Kyiv RC Kyiv Regional Clinical Hospital
  - Kyiv, Ukraine, 01023
    - MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  - Lviv, Ukraine, 79059
    - Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  - Lviv, Ukraine, 46002
    - CI of TRC Ternopil University Hospital
  - Odesa, Ukraine, 65025
    - CI Odesa Regional Clinical Hospital
  - Uzhgorod, Ukraine, 88009
    - SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
  - Vinnytsia, Ukraine, 21029
    - SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
  - Vinnytsia, Ukraine, 21001
    - Private Small Enterprise Medical Center Pulse
  - Vinnytsia, Ukraine, 21029
    - MCIC MC LLC Health Clinic
  - Vinnytsia, Ukraine, 21005
    - Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
  - Zaporizhzhia, Ukraine, 69035
    - CI City Clinical Hospital #6 Dept of Gastroenterology
  - Zaporizhzhia, Ukraine, 69104
    - SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
United Kingdom
- Devon
  - Plymouth, Devon, United Kingdom, PL6 5FP
    - Derriford Hospital
- Greater Manchester
  - Salford, Greater Manchester, United Kingdom, M6 8HD
    - Salford Royal
- Norfolk
  - Norwich, Norfolk, United Kingdom, NR47UY
    - Norfolk and Norwich University Hospital
- Strathclyde
  - Glasgow, Strathclyde, United Kingdom, G4 0SF
    - Glasgow Royal Infirmary
- West Midlands
  - Coventry, West Midlands, United Kingdom, CV2 2DX
    - University Hospital Coventry
  - Wolverhampton, West Midlands, United Kingdom, WV10 0QP
    - Royal Wolverhampton hospital
United States
- Alabama
  - Mobile, Alabama, United States, 36604
    - IMC - Diagnostic and Medical Clinic
- Arizona
  - Phoenix, Arizona, United States, 85037
    - Arizona Arthritis & Rheumatology Research, PLLC
- Arkansas
  - Little Rock, Arkansas, United States, 72204
    - Arkansas Primary Care Clinic, PA
- California
  - Costa Mesa, California, United States, 92626
    - WCCT Global (PH 1 Unit)
  - Northridge, California, United States, 91324
    - California Medical Research Associates Inc.
  - Sacramento, California, United States, 95816
    - Sutter Institute for Medical Research
- Colorado
  - Lakewood, Colorado, United States, 80214-5434
    - Rocky Mountain Gastroenterology
- Connecticut
  - Hamden, Connecticut, United States, 06518
    - Medical Research Center of Connecticut, LLC
- Florida
  - Aventura, Florida, United States, 33180
    - Innovative Medical Research of South Florida, Inc.
  - Doral, Florida, United States, 33172
    - Advanced Clinical Research of Miami
  - Hialeah Gardens, Florida, United States, 33016
    - Wellness Clinical Research
  - Inverness, Florida, United States, 34452
    - Nature Coast Clinical Research, LLC
  - Largo, Florida, United States, 33773-1615
    - Florida Center for Gastroenterology
  - Miami, Florida, United States, 33165
    - Medical Professional Clinical Research
  - Miami, Florida, United States, 33173
    - Tellus Clinical Research, Inc.
  - Miami, Florida, United States, 33143
    - Gastro Health
  - Miami Springs, Florida, United States, 33166
    - South Florida Research Phase I-IV
  - Naples, Florida, United States, 34102
    - Gastroenterology Group Of Naples
  - Orlando, Florida, United States, 32806
    - Internal Medicine Specialists
  - Plantation, Florida, United States, 33322
    - BRCR Medical Center, Inc.
  - Pompano Beach, Florida, United States, 33060
    - Clinical Research Center Of Florida
  - Winter Park, Florida, United States, 32789
    - Shafran Gastroenterology Center
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital
  - Macon, Georgia, United States, 31201
    - Gastroenterology Associates of Central Georgia
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60611
    - Northwestern University Feinberg School of Medicine
  - Urbana, Illinois, United States, 61801
    - Carle Foundation Hospital
- Indiana
  - New Albany, Indiana, United States, 47150
    - Gastroenterology of Southern Associates
- Iowa
  - Clive, Iowa, United States, 50325
    - Iowa Digestive Disease Center
- Kansas
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Clinical Research Center, Digestive Health
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - University of Louisville
  - Owensboro, Kentucky, United States, 42303
    - Research Concierge, LLC
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Gastroenterology Associates, LLC
  - Lafayette, Louisiana, United States, 70503
    - Lafayette General Medical Center
  - Metairie, Louisiana, United States, 70006
    - Clinical Trials Management, LLC
  - Shreveport, Louisiana, United States, 71103
    - Louisiana Research Center, LLC
- Maryland
  - Catonsville, Maryland, United States, 21228
    - Digestive Disease Associates
  - Chevy Chase, Maryland, United States, 20815
    - Chevy Chase Clinical Research
- Michigan
  - Chesterfield, Michigan, United States, 48047
    - Clinical Research Institute of Michigan, LLC
  - Troy, Michigan, United States, 48098
    - Center for Digestive Health and Nutritional Excellence
  - Wyoming, Michigan, United States, 49519
    - Gastroenterology Associates of Western Michigan, P.L.C.
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic - Rochester
- Mississippi
  - Ocean Springs, Mississippi, United States, 39564
    - Digestive Health Center PA
- Missouri
  - Belton, Missouri, United States, 64012
    - Ehrhardt Clinical Research, LLC
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Centers, Inc.
- Nebraska
  - Omaha, Nebraska, United States, 68124
    - Alegent Creighton Clinic Gastroenterology
- New Jersey
  - Egg Harbor Township, New Jersey, United States, 08234
    - AGA Clinical Research Associates, LLC
- New York
  - Great Neck, New York, United States, 11021
    - Long Island Clinical Research Associates
  - Lake Success, New York, United States, 10029
    - Mount Sinai - PRIME
  - New Hyde Park, New York, United States, 11040
    - Digestive Disease Care
  - Poughkeepsie, New York, United States, 12601
    - Premier Medical Group of the Hudson Valley, PC
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7080
    - University of North Carolina at Chapel Hill
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Consultants for Clinical Research Inc.
  - Columbus, Ohio, United States, 43210
    - Ohio State University Clinical Trials Management Office
  - Dayton, Ohio, United States, 45415
    - Dayton Gastroenterology, Inc
  - Lima, Ohio, United States, 45806
    - Gastro-Enterology Research of Lima
- Oklahoma
  - Tulsa, Oklahoma, United States, 74104
    - Options Health Research
- Oregon
  - Portland, Oregon, United States, 97225
    - The Oregon Clinic-West Hills Gastroenterology
- Pennsylvania
  - Malvern, Pennsylvania, United States, 19355
    - Main Line Gastroenterology Associates
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina (MUSC)
  - West Columbia, South Carolina, United States, 29169
    - Invocare Clinical Research Center
- Tennessee
  - Nashville, Tennessee, United States, 37212-1375
    - Vanderbilt University Medical Center
- Texas
  - Dallas, Texas, United States, 75246
    - Baylor University Hospital
  - Dallas, Texas, United States, 75231
    - Texas Digestive Disease Consultants - Dallas
  - El Paso, Texas, United States, 79935
    - MedResearch, Inc
  - Harlingen, Texas, United States, 78550
    - Gastroenterology Consultants of South Texas, PA
  - Houston, Texas, United States, 77098
    - Gulf Coast Research Group LLC
  - Irving, Texas, United States, 75039
    - Texas Digestive Disease Consultants - Irving
  - Plano, Texas, United States, 75093
    - Advanced Clinical Research Associates
  - San Antonio, Texas, United States, 78229
    - Gastroenterology Research of San Antonio, LLC
  - Southlake, Texas, United States, 76092
    - Texas Digestive Disease Consultants - Southlake
  - Tyler, Texas, United States, 75701
    - Digestive Health Specialists of Tyler
- Virginia
  - Chesapeake, Virginia, United States, 23320
    - Gastroenterology Associates of Tidewater
- Washington
  - Seattle, Washington, United States, 98101
    - Virginia Mason Seattle Main Clinic
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital & Clinics
- Wisconsin
  - Madison, Wisconsin, United States, 53705
    - University of Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Allegiance Research Specialists, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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:
1. 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
2. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued its use due to reasons other than safety, or
3. Is naïve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).

Exclusion Criteria:

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:
1. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in Section Permitted Medications For Treatment of UC.
2. 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.
Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.
Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vedolizumab IV 300 mg Vedolizumab 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.	Drug: Vedolizumab Vedolizumab infusion Drug: Adalimumab placebo Adalimumab placebo-matching injection
Active Comparator: Adalimumab SC 160/80/40 mg Adalimumab 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.	Drug: Adalimumab Adalimumab injection Drug: Vedolizumab placebo Vedolizumab placebo-matching infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Clinical Remission Time Frame: Week 52	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Mucosal Healing Time Frame: Week 52	Mucosal healing was defined as a Mayo score endoscopic subscore of <= 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
Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission Time Frame: Week 52	Corticosteroid-free remission was defined as participants using oral corticosteroids at Baseline (Week 0) who had discontinued oral corticosteroids and were in clinical remission at Week 52. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2015

Primary Completion (Actual)

September 26, 2018

Study Completion (Actual)

January 18, 2019

Study Registration Dates

First Submitted

July 10, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Drug Therapy

Additional Relevant MeSH Terms

Other Study ID Numbers

MLN0002-3026
U1111-1168-6713 (Registry Identifier: WHO)
2015-000939-33 (EudraCT Number)
NL54690.056.15 (Registry Identifier: CCMO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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