AzTrials
AzTrials

Colitis, UlcerativePhase 3NCT02497469

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

A Phase 3 study testing Vedolizumab and Adalimumab in people with Colitis, Ulcerative, run by Takeda at 330 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Vedolizumab and Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
771 participants
Where
330 sitesin 34 countries
Study dates
29 Jun 2015to 18 Jan 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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:
  • Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in Section Permitted Medications For Treatment of UC.
Show all 17Show fewer
  • 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.

Trial locations and contacts

330 sites in 34 countries.

330 sites in 34 countries

United States77 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Innovative Medical Research of South Florida, Inc.

    Aventura, Florida, 33180

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Ehrhardt Clinical Research, LLC

    Belton, Missouri, 64012

  • Digestive Disease Associates

    Catonsville, Maryland, 21228

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7080

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Consultants for Clinical Research Inc.

    Cincinnati, Ohio, 45219

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Ohio State University Clinical Trials Management Office

    Columbus, Ohio, 43210

  • WCCT Global (PH 1 Unit)

    Costa Mesa, California, 92626

  • Texas Digestive Disease Consultants - Dallas

    Dallas, Texas, 75231

  • Baylor University Hospital

    Dallas, Texas, 75246

  • Dayton Gastroenterology, Inc

    Dayton, Ohio, 45415

  • Advanced Clinical Research of Miami

    Doral, Florida, 33172

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • MedResearch, Inc

    El Paso, Texas, 79935

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Gastroenterology Consultants of South Texas, PA

    Harlingen, Texas, 78550

  • Wellness Clinical Research

    Hialeah Gardens, Florida, 33016

  • Gulf Coast Research Group LLC

    Houston, Texas, 77098

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • Texas Digestive Disease Consultants - Irving

    Irving, Texas, 75039

  • Truman Medical Centers, Inc.

    Kansas City, Missouri, 64108

  • Lafayette General Medical Center

    Lafayette, Louisiana, 70503

  • Mount Sinai - PRIME

    Lake Success, New York, 10029

  • Rocky Mountain Gastroenterology

    Lakewood, Colorado, 80214-5434

  • Florida Center for Gastroenterology

    Largo, Florida, 33773-1615

  • Gastro-Enterology Research of Lima

    Lima, Ohio, 45806

  • Arkansas Primary Care Clinic, PA

    Little Rock, Arkansas, 72204

  • University of Louisville

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Main Line Gastroenterology Associates

    Malvern, Pennsylvania, 19355

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Gastro Health

    Miami, Florida, 33143

  • Medical Professional Clinical Research

    Miami, Florida, 33165

  • Tellus Clinical Research, Inc.

    Miami, Florida, 33173

  • South Florida Research Phase I-IV

    Miami Springs, Florida, 33166

  • Allegiance Research Specialists, LLC

    Milwaukee, Wisconsin, 53226

  • IMC - Diagnostic and Medical Clinic

    Mobile, Alabama, 36604

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212-1375

  • Gastroenterology of Southern Associates

    New Albany, Indiana, 47150

  • Digestive Disease Care

    New Hyde Park, New York, 11040

  • California Medical Research Associates Inc.

    Northridge, California, 91324

  • Digestive Health Center PA

    Ocean Springs, Mississippi, 39564

  • Alegent Creighton Clinic Gastroenterology

    Omaha, Nebraska, 68124

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Research Concierge, LLC

    Owensboro, Kentucky, 42303

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona, 85037

  • Advanced Clinical Research Associates

    Plano, Texas, 75093

  • BRCR Medical Center, Inc.

    Plantation, Florida, 33322

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • The Oregon Clinic-West Hills Gastroenterology

    Portland, Oregon, 97225

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • Gastroenterology Research of San Antonio, LLC

    San Antonio, Texas, 78229

  • Virginia Mason Seattle Main Clinic

    Seattle, Washington, 98101

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • Texas Digestive Disease Consultants - Southlake

    Southlake, Texas, 76092

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

    Topeka, Kansas, 66606

  • Center for Digestive Health and Nutritional Excellence

    Troy, Michigan, 48098

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • Invocare Clinical Research Center

    West Columbia, South Carolina, 29169

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

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

    Wyoming, Michigan, 49519

Other trials in United States

Russia20 sites

  • SBEI HPE "Kazan State Medical University" of the MoH of the RF

    Kazan', 420012

  • TSBIH "Territorial Clinical Hospital"

    Krasnoyarsk, 660022

  • Research Institute of Gastroenterology

    Moscow, 111123

  • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

    Moscow, 119333

  • FSBI State Scientific Centre of Coloproctology" of the MoH of RF

    Moscow, 123154

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

    Nizhny Novgorod, 603126

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630091

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

    Novosibirsk, 630117

  • BHI of Omsk region Clinical Oncology Dispensary

    Omsk, 644013

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

    Omsk, 644099

  • SBEI HPE "Rostov State Medical University" of the MoH of the RF

    Rostov-on-Don, 344022

  • FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia

    Saint Petersburg, 194044

  • SPb SBIH "City Hospital of Saint Martyr Elizaveta"

    Saint Petersburg, 195257

  • SPb SBIH "City Hospital # 26"

    Saint Petersburg, 196247

  • SPb SBIH "City Hospital # 9"

    Saint Petersburg, 197110

  • Private Educational Institution of Higher Education "Medical University "REAVIZ"

    Samara, 443115

  • SIH "Regional Clinical Hospital "

    Saratov, 410053

  • SPb SBIH "City Hospital # 40 of Kurortnyi region"

    Sestroretsk, 197706

  • RSBIH "Smolensk Regional Clinical Hospital"

    Smolensk, 214019

  • SBIH of Yaroslavl region " Regional Clinical Hospital "

    Yaroslavl, 150062

Other trials in Russia

Ukraine20 sites

  • RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

    Chernivtsi, 58002

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

    Dnipropetrovsk, 49074

  • Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU

    Ivano-Frankivsk, 76008

  • CI of PH Kharkiv CCH #2

    Kharkiv, 61037

  • CI A.and O. Tropiny City Clinical Hospital

    Kherson, 73000

  • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

    Kirovohrad, 25006

  • CI of Kyiv RC Kyiv Regional Clinical Hospital

    Kyiv, 01023

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

    Kyiv, 01023

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

    Kyiv, 01103

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

    Kyiv, 04201

  • CI of TRC Ternopil University Hospital

    Lviv, 46002

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

    Lviv, 79059

  • CI Odesa Regional Clinical Hospital

    Odesa, 65025

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

    Uzhhorod, 88009

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001

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

    Vinnytsia, 21005

  • MCIC MC LLC Health Clinic

    Vinnytsia, 21029

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

    Vinnytsia, 21029

  • CI City Clinical Hospital #6 Dept of Gastroenterology

    Zaporizhzhya, 69035

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

    Zaporizhzhya, 69104

Other trials in Ukraine

Poland17 sites

  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

    Bialystok, 15-275

  • NZOZ Vitamed

    Bydgoszcz, 85-079

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • SP CSK im. prof. K. Gibinskiego SUM

    Katowice, 40-752

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

  • SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM

    Lodz, 90-153

  • Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, 90-302

  • GASTROMED Sp. z o.o.

    Lublin, 20-582

  • SOLUMED Centrum Medyczne

    Poznan, 60-529

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • Centrum Zdrowia Matki, Dziecka i Mlodziezy

    Warsaw, 00-632

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warsaw, 02-507

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw, 02-781

  • Nzoz Vivamed

    Warsaw, 03-580

  • LexMedica Osrodek Badan Klinicznych

    Wroclaw, 53-114

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

    Wroclaw, 53-333

  • EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu

    Wroclaw, 54-144

Other trials in Poland

Italy16 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Ospedale Cannizzaro

    Catania, 95100

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

  • Azienda Ospedaliera Universitaria Policlinico G. Martino

    Messina, 98125

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

    Milan, 20157

  • A.O.U. Policlinico di Modena

    Modena, 41124

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131

  • Seconda Universita degli Studi di Napoli

    Naples, 80131

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, 90146

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • I.R.C.C.S Policlinico San Donato

    San Donato Milanese, Milano, 20097

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

South Korea14 sites

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, Gyeongsangbuk-do, 700-721

  • Yeungnam University Hospital

    Daegu, 42415

  • Hanyang Univerisy Guri Hospital

    Guri-si, Gyeonggi-do, 11923

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

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

    Suwon, Gyeonggi-do, 16247

Other trials in South Korea

Bulgaria13 sites

  • MHAT - Pazardzhik AD

    Pazardzhik, 4400

  • MHAT 'Avis Medica' OOD

    Pleven, 5800

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • MHAT "Hadzhi Dimitar", OOD

    Sliven, 8800

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

  • Medical Center "Excelsior", OOD

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD

    Sofia, 1527

  • Fourth MHAT - Sofia EAD

    Sofia, 1606

  • Military Medical Academy - MHAT - Sofia

    Sofia, 1606

  • UMHAT 'Sveta Anna' AD

    Sofia, 1750

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora, 6000

  • MHAT 'Sv. Marina', EAD

    Varna, 9020

Other trials in Bulgaria

Germany12 sites

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353

  • Krankenhaus Waldfriede e. V.

    Berlin, 141 63

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, Hesse, 60590

  • Asklepios Klinik Hamburg

    Hamburg, 22559

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • EUGASTRO GmbH

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Universitaetsklinikum Magdeburg A.oe.R

    Magdeburg, Saxony-Anhalt, 39120

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

France11 sites

  • CHU Amiens - Hopital Sud

    Amiens, Somme, 80054

  • Hopital Beaujon

    Clichy, Hauts De Seine, 92110

  • Centre Hospitalier Departemental Les Oudairies

    La Roche S/ Yon Cedex 9, Vendee, 85925

  • Hopital Claude Huriez - CHU Lille

    Lille, Nord, 59037

  • Hopital Saint Joseph

    Marseille, Bouches-du-Rhone, 13008

  • Hopital Nord - CHU Marseille

    Marseille, Bouches-du-Rhone, 13915

  • CHU Nice - Hopital de l'Archet 2

    Nice, Alpes Maritimes, 06200

  • Groupe Hospitalier Sud - Hopital Haut-Leveque

    Pessac, Gironde, 33604

  • CHU Saint Etienne - Hopital Nord

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, Haute Garonne, 31059

  • Hopital de Brabois Adultes

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511

Other trials in France

Israel11 sites

  • HaEmek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78278

  • Hillel Yaffe Medical

    Hadera, 3810101

  • Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Clalit Health Services-Lev Talpiyot

    Jerusalem, 9362410

  • Meir Medical Center

    Kfar Saba, 4428164

  • Galilee Medical Center

    Nahariya, 22100

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Hungary10 sites

  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

    Békéscsaba, 5600

  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont

    Budapest, 1076

  • Semmelweis Egyetem

    Budapest, 1083

  • Semmelweis Egyetem

    Budapest, 1088

  • Pannonia Maganorvosi Centrum

    Budapest, 1136

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, 3300

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100

Other trials in Hungary

Czechia9 sites

  • CCBR - Brno - CZ

    Brno, 60200

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • CCBR Czech, a.s

    Pardubice, 530 02

  • A-Shine

    Pilsen, 31200

  • CCBR - Prague - CZ

    Prague, 13000

  • Klinicke centrum ISCARE Lighthouse

    Prague, 17004

  • Axon Clinical, s.r.o.

    Prague, 182 00

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ballarat Base Hospital

    Ballarat, Victoria, 3350

  • Tennyson Centre Day Hospital

    Bedford Park, South Australia, 5042

  • Monash Medical Centre Moorabbin

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Frances Xavier Cabrini Hospital

    Malvern, Victoria, 3144

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada7 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2X8

  • McMaster University Health Sciences Center

    Hamilton, Ontario, L8N3Z5

  • Hotel Dieu Hospital

    Kingston, Ontario, K7L 5G2

  • LHSC - University Hospital

    London, Ontario, N6A 5A5

  • LHSC - Victoria Hospital

    London, Ontario, N6A 5W9

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Croatia7 sites

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • General Hospital Pula

    Pula, 52100

  • Polyclinic Medico

    Rijeka, 51000

  • Clinical Hospital Center "Sestre Milosrdnice"

    Zagreb, 10000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • Clinical Hospital Merkur

    Zagreb, 10000

Other trials in Croatia

Serbia7 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Center Zvezdara

    Belgrade, 11000

  • Clinical Center Bezanijska kosa

    Belgrade, 11080

  • Clinical Center Zemun

    Belgrade, 11080

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Portugal6 sites

  • Hospital de Braga

    Braga, 4710-243

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

    Coimbra, 3000-075

  • Centro Hospitalar Cova da Beira

    Covilha, 6200-502

  • Hospital da Senhora da Oliveira Guimaraes

    Guimarães, 4835-044

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

    Viana do Castelo, 4904-858

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

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Slovakia6 sites

  • IBDcentrum s.r.o.

    Bratislava, 81108

  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

    Bratislava, 82606

  • Gastroped s.r.o.

    Košice, 04001

  • KM Management spol. s r.o.

    Nitra, 949 01

  • Gastro I, s.r.o.

    Prešov, 080 01

  • Frantisek Horvath- GEA

    Šahy, 936 01

Other trials in Slovakia

Turkey (Türkiye)6 sites

  • Ankara University Medical Faculty

    Ankara, 06100

  • Acibadem Fulya Hospital

    Istanbul, 34349

  • Haydarpasa Numune Training and Research Hospital

    Istanbul, 34668

  • Marmara University Pendik Research and Training Hospital

    Istanbul, 34899

  • Kocaeli Derince Training and Research Hospital

    Kocaeli, 41380

  • Mersin University Medical Faculty

    Mersin, 33343

Other trials in Turkey (Türkiye)

United Kingdom6 sites

  • University Hospital Coventry

    Coventry, West Midlands, CV2 2DX

  • Glasgow Royal Infirmary

    Glasgow, Strathclyde, G4 0SF

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR47UY

  • Derriford Hospital

    Plymouth, Devon, PL6 5FP

  • Salford Royal

    Salford, Greater Manchester, M6 8HD

  • Royal Wolverhampton hospital

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Mexico5 sites

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

  • Morales Vargas Centro de Investigacion, S.C.

    León, Guanajuato, 37000

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

    León, Guanajuato, 37520

  • Christus Muguerza Sur S.A. de C.V.

    Monterrey, Nuevo León, 64908

  • Sociedad de Metabolismo y Corazon S.C

    Veracruz, 91910

Other trials in Mexico

Netherlands5 sites

  • Onze Lieve Vrouwe Gasthuis, Locatie Oost

    Amsterdam, 1091 AC

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Universitair Medisch Centrum Groningen (UMCG)

    Groningen, 9713 GZ

  • Maastricht University Medical Center

    Maastricht, 6202 AZ

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

Argentina4 sites

  • Expertia S.A- Mautalen Salud e Investigacion

    Ciudad Autonoma Buenos Aires, C1128AAE

  • Centro de Investigaciones Clinicas Instituto del Corazon

    Córdoba, X5000EVQ

  • Instituto de Investigaciones Clinicas-Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZ

  • Instituto Medico CER

    Quilmes, Buenos Aires, B1878DVB

Other trials in Argentina

Denmark4 sites

  • Nordsjallands Hospital, Frederikssund

    Frederikssund, 3600

  • Hvidovre_Hospital

    Hvidovre, 2650

  • Koge Sygehus

    Køge, 4600

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Lithuania4 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50009

  • Klaipeda Republican Hospital, Public Institution

    Klaipėda, 92231

  • Klaipeda University Hospital, Public Institution

    Klaipėda, 92288

  • Vilnius University Hospital Santariskiu Clinic, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

Spain4 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

Other trials in Spain

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chung Shan Medical University Hospital

    Taichung, 402

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 10449

Other trials in Taiwan

Bosnia and Herzegovina3 sites

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000

  • University Clinical Hospital Mostar

    Mostar, 88000

  • University Clinic Centre Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Estonia3 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 50406

Other trials in Estonia

Hong Kong3 sites

  • The University of Hong Kong

    Hong Kong

  • Tuen Mun Hospital

    Medicine & Geriatrics, 00000

  • The Chinese University of Hong Kong

    Shatin, 00000

Other trials in Hong Kong

Romania3 sites

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

    Timișoara, 300002

Other trials in Romania

Colombia2 sites

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, 681004

  • Instituto de Coloproctologia ICO S.A.S.

    Medellín, 050025

Other trials in Colombia

Latvia2 sites

  • Digestive Diseases Center "Gastro"

    Riga, LV-1006

  • Pauls Stradins Clinical University Hospital SLLC

    Riga, LV1002

Other trials in Latvia

Belgium1 site

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Vedolizumab, Adalimumab placebo, Adalimumab, Vedolizumab placebo
Keywords
Drug Therapy
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VedolizumabDrug

    Vedolizumab infusion

  • Adalimumab placeboDrug

    Adalimumab placebo-matching injection

  • AdalimumabDrug

    Adalimumab injection

  • Vedolizumab placeboDrug

    Vedolizumab placebo-matching infusion

Study groups in NCT02497469
Study groupRoleWhat they receive
Vedolizumab IV 300 mgExperimentalVedolizumab 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.
Receives: Drug: Vedolizumab; Drug: Adalimumab placebo
Adalimumab SC 160/80/40 mgActive comparatorAdalimumab 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.
Receives: Drug: Adalimumab; Drug: Vedolizumab placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved Clinical Remission

    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).

    Measured: Week 52

Secondary outcomes (2)

  1. Percentage of Participants Who Achieved Mucosal Healing

    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).

    Measured: Week 52

  2. Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission

    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).

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2015 (estimated)
  2. Study start29 Jun 2015
  3. Primary completion26 Sep 2018
  4. Study completion18 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
771 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02497469
Sponsor's protocol ID
MLN0002-3026
Other IDs
U1111-1168-6713, 2015-000939-33, NL54690.056.15, 2015
Status last verified
Jan 2020
First submitted
10 Jul 2015
Last updated
28 Jan 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.

    PubMed 35934286

  • Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Danese S, Rogers R, Bornstein JD, Chen J, Schreiber S, Sands BE, Lirio RA. Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY). Gastroenterology. 2021 Oct;161(4):1156-1167.e3. doi: 10.1053/j.gastro.2021.06.015. Epub 2021 Jun 16.

    PubMed 34144047

  • Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Toruner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.

    PubMed 31553834

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab and Adalimumab in people with Colitis, Ulcerative, run by Takeda at 330 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 330 sites in United States, Russia, Ukraine, Poland, Italy and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved Clinical Remission (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02497469, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.

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