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

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vedolizumab
Adalimumab placebo
Adalimumab
Vedolizumab placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Drug Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
  4. 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).

  5. 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:

  1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.
  2. Has had an extensive colonic resection, subtotal or total colectomy.
  3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
  4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.

  5. 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.
  6. Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
  7. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 antibodies, or rituximab.
  8. Has previously received vedolizumab.
  9. Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
  10. Evidence of an active infection during Screening.
  11. Evidence of, or treatment for, Clostridium difficile (C. difficile) or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
  12. 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).
  13. Has active or latent TB, regardless of treatment history.
  14. 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.
  15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

Sites / Locations

  • IMC - Diagnostic and Medical Clinic
  • Arizona Arthritis & Rheumatology Research, PLLC
  • Arkansas Primary Care Clinic, PA
  • WCCT Global (PH 1 Unit)
  • California Medical Research Associates Inc.
  • Sutter Institute for Medical Research
  • Rocky Mountain Gastroenterology
  • Medical Research Center of Connecticut, LLC
  • Innovative Medical Research of South Florida, Inc.
  • Advanced Clinical Research of Miami
  • Wellness Clinical Research
  • Nature Coast Clinical Research, LLC
  • Florida Center for Gastroenterology
  • South Florida Research Phase I-IV
  • Gastro Health
  • Medical Professional Clinical Research
  • Tellus Clinical Research, Inc.
  • Gastroenterology Group of Naples
  • Internal Medicine Specialists
  • BRCR Medical Center, Inc.
  • Clinical Research Center of Florida
  • Shafran Gastroenterology Center
  • Emory University Hospital
  • Gastroenterology Associates of Central Georgia
  • Northwestern University Feinberg School of Medicine
  • Rush University Medical Center
  • Carle Foundation Hospital
  • Gastroenterology of Southern Associates
  • Iowa Digestive Disease Center
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • University of Louisville
  • Research Concierge, LLC
  • Gastroenterology Associates, LLC
  • Lafayette General Medical Center
  • Clinical Trials Management, LLC
  • Louisiana Research Center, LLC
  • Digestive Disease Associates
  • Chevy Chase Clinical Research
  • Clinical Research Institute of Michigan, LLC
  • Center for Digestive Health and Nutritional Excellence
  • Gastroenterology Associates of Western Michigan, P.L.C.
  • Mayo Clinic - Rochester
  • Digestive Health Center PA
  • Ehrhardt Clinical Research, LLC
  • Truman Medical Centers, Inc.
  • Alegent Creighton Clinic Gastroenterology
  • AGA Clinical Research Associates, LLC
  • Long Island Clinical Research Associates
  • Mount Sinai - PRIME
  • Digestive Disease Care
  • Premier Medical Group of the Hudson Valley, PC
  • University of North Carolina at Chapel Hill
  • Consultants for Clinical Research Inc.
  • Ohio State University Clinical Trials Management Office
  • Dayton Gastroenterology, Inc
  • Gastro-Enterology Research of Lima
  • Options Health Research
  • The Oregon Clinic-West Hills Gastroenterology
  • Main Line Gastroenterology Associates
  • Medical University of South Carolina (MUSC)
  • Invocare Clinical Research Center
  • Vanderbilt University Medical Center
  • Texas Digestive Disease Consultants - Dallas
  • Baylor University Hospital
  • MedResearch, Inc
  • Gastroenterology Consultants of South Texas, PA
  • Gulf Coast Research Group LLC
  • Texas Digestive Disease Consultants - Irving
  • Advanced Clinical Research Associates
  • Gastroenterology Research of San Antonio, LLC
  • Texas Digestive Disease Consultants - Southlake
  • Digestive Health Specialists of Tyler
  • Gastroenterology Associates of Tidewater
  • Virginia Mason Seattle Main Clinic
  • Wenatchee Valley Hospital & Clinics
  • University of Wisconsin
  • Allegiance Research Specialists, LLC
  • Instituto de Investigaciones Clinicas-Mar del Plata
  • Instituto Medico CER
  • Expertia S.A- Mautalen Salud e Investigacion
  • Centro de Investigaciones Clinicas Instituto del Corazon
  • Concord Repatriation General Hospital
  • Mater Adult Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Tennyson Centre Day Hospital
  • Ballarat Base Hospital
  • Monash Medical Centre Moorabbin
  • St Frances Xavier Cabrini Hospital
  • Universitair Ziekenhuis Gent
  • University Clinical Centre of the Republic of Srpska
  • University Clinical Hospital Mostar
  • University Clinic Centre Sarajevo
  • MHAT - Pazardzhik AD
  • MHAT 'Avis Medica' OOD
  • UMHAT 'Dr. Georgi Stranski', EAD
  • MHAT "Hadzhi Dimitar", OOD
  • "City Clinic UMHAC" EOOD
  • Medical Center "Excelsior", OOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Fourth MHAT - Sofia EAD
  • Military Medical Academy - MHAT - Sofia
  • UMHAT 'Sveta Anna' AD
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • MHAT 'Sv. Marina', EAD
  • University of Alberta
  • McMaster University Health Sciences Center
  • Hotel Dieu Hospital
  • LHSC - University Hospital
  • LHSC - Victoria Hospital
  • Toronto Digestive Disease Associates, Inc.
  • Royal University Hospital
  • Fundacion Oftalmologica de Santander - FOSCAL
  • Instituto de Coloproctologia ICO S.A.S.
  • Clinical Hospital Centre Osijek
  • General Hospital Pula
  • Polyclinic Medico
  • Clinical Hospital Center "Sestre Milosrdnice"
  • Clinical Hospital Centre Zagreb
  • Clinical Hospital Dubrava
  • Clinical Hospital Merkur
  • CCBR - Brno - CZ
  • Fakultni nemocnice u sv. Anny v Brne
  • Hepato-Gastroenterologie HK, s.r.o.
  • CCBR Czech, a.s
  • A-Shine
  • CCBR - Prague - CZ
  • Thomayerova nemocnice
  • Klinicke centrum ISCARE Lighthouse
  • Axon Clinical, s.r.o.
  • Nordsjallands Hospital, Frederikssund
  • Hvidovre_Hospital
  • Koge Sygehus
  • Odense Universitetshospital
  • West Tallinn Central Hospital
  • North Estonia Medical Centre Foundation
  • Tartu University Hospital
  • CHU Nice - Hopital de l'Archet 2
  • Hopital Nord - CHU Marseille
  • Hopital Saint Joseph
  • Groupe Hospitalier Sud - Hopital Haut-Leveque
  • CHU de Toulouse - Hopital Rangueil
  • Hopital Beaujon
  • CHU Saint Etienne - Hopital Nord
  • Hopital de Brabois Adultes
  • Hopital Claude Huriez - CHU Lille
  • CHU Amiens - Hopital Sud
  • Centre Hospitalier Departemental Les Oudairies
  • Universitaetsklinikum Heidelberg
  • Universitaetsklinikum Tuebingen
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Universitaetsklinikum Koeln
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Universitaetsklinikum Magdeburg A.oe.R
  • EUGASTRO GmbH
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  • Charite - Campus Virchow-Klinikum
  • Krankenhaus Waldfriede e. V.
  • Asklepios Klinik Hamburg
  • The University of Hong Kong
  • Tuen Mun Hospital
  • The Chinese University of Hong Kong
  • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
  • Semmelweis Egyetem
  • Semmelweis Egyetem
  • Pannonia Maganorvosi Centrum
  • Debreceni Egyetem Klinikai Kozpont
  • Markhot Ferenc Oktatokorhaz es Rendelointezet
  • Pecsi Tudomanyegyetem
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Tolna Megyei Balassa Janos Korhaz
  • HaEmek Medical Center
  • Barzilai Medical Center
  • Hillel Yaffe Medical
  • Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Clalit Health Services-Lev Talpiyot
  • Meir Medical Center
  • Galilee Medical Center
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Istituto Clinico Humanitas
  • I.R.C.C.S Policlinico San Donato
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Azienda Ospedaliera Ospedale Cannizzaro
  • Azienda Ospedaliero Universitaria San Martino
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • A.O.U. Policlinico di Modena
  • Azienda Ospedaliera Universitaria "Federico II"
  • Seconda Universita degli Studi di Napoli
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Azienda Ospedaliera Vincenzo Cervello
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera San Camillo Forlanini
  • Hanyang Univerisy Guri Hospital
  • Seoul National University Bundang Hospital
  • The Catholic University of Korea, St. Vincent's Hospital
  • Kyungpook National University Hospital
  • Pusan National University Hospital
  • Yeungnam University Hospital
  • Kyung Hee University Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Marys Hospital
  • Digestive Diseases Center "Gastro"
  • Pauls Stradins Clinical University Hospital SLLC
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Klaipeda Republican Hospital, Public Institution
  • Klaipeda University Hospital, Public Institution
  • Vilnius University Hospital Santariskiu Clinic, Public Institution
  • Morales Vargas Centro de Investigacion, S.C.
  • Centro de Investigacion Farmacologica del Bajio, S.C.
  • Christus Muguerza Sur S.A. de C.V.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Sociedad de Metabolismo y Corazon S.C
  • Onze Lieve Vrouwe Gasthuis, Locatie Oost
  • Academisch Medisch Centrum
  • Universitair Medisch Centrum Groningen (UMCG)
  • Maastricht University Medical Center
  • Erasmus Medisch Centrum
  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  • NZOZ Vitamed
  • Uniwersyteckie Centrum Kliniczne
  • SP CSK im. prof. K. Gibinskiego SUM
  • Gabinet Endoskopii Przewodu Pokarmowego
  • SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
  • Santa Familia Centrum Badan, Profilaktyki i Leczenia
  • GASTROMED Sp. z o.o.
  • SOLUMED Centrum Medyczne
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Centralny Szpital Kliniczny MSW w Warszawie
  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Nzoz Vivamed
  • LexMedica Osrodek Badan Klinicznych
  • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
  • EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu
  • Hospital de Braga
  • Centro Hospitalar e Universitario de Coimbra E.P.E
  • Centro Hospitalar Cova da Beira
  • Hospital da Senhora da Oliveira Guimaraes
  • Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE
  • Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
  • Spitalul Clinic Colentina
  • Institutul Clinic Fundeni
  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
  • SBEI HPE "Kazan State Medical University" of the MoH of the RF
  • TSBIH "Territorial Clinical Hospital"
  • Research Institute of Gastroenterology
  • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
  • FSBI State Scientific Centre of Coloproctology" of the MoH of RF
  • SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
  • SBEIHPE Novosibirsk State Medical University
  • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
  • BHI of Omsk region Clinical Oncology Dispensary
  • SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
  • SBEI HPE "Rostov State Medical University" of the MoH of the RF
  • FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
  • SPb SBIH "City Hospital # 26"
  • SPb SBIH "City Hospital # 9"
  • Private Educational Institution of Higher Education "Medical University "REAVIZ"
  • SIH "Regional Clinical Hospital "
  • SPb SBIH "City Hospital # 40 of Kurortnyi region"
  • RSBIH "Smolensk Regional Clinical Hospital"
  • SPb SBIH "City Hospital of Saint Martyr Elizaveta"
  • SBIH of Yaroslavl region " Regional Clinical Hospital "
  • Clinical Center of Serbia
  • Clinical Center Zvezdara
  • Clinical Center Bezanijska kosa
  • Clinical Center Zemun
  • Clinical Center Kragujevac
  • Clinical Center Nis
  • Clinical Center of Vojvodina
  • IBDcentrum s.r.o.
  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Gastroped s.r.o.
  • KM Management spol. s r.o.
  • Gastro I, s.r.o.
  • Frantisek Horvath- GEA
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital General Universitario de Alicante
  • Hospital Universitario Ramon y Cajal
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Chung Shan Medical University Hospital
  • National Taiwan University Hospital
  • Mackay Memorial Hospital
  • Ankara University Medical Faculty
  • Acibadem Fulya Hospital
  • Haydarpasa Numune Training and Research Hospital
  • Marmara University Pendik Research and Training Hospital
  • Kocaeli Derince Training and Research Hospital
  • Mersin University Medical Faculty
  • RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
  • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
  • Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
  • CI of PH Kharkiv CCH #2
  • CI A.and O. Tropiny City Clinical Hospital
  • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
  • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
  • CI of TRC Ternopil University Hospital
  • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  • CI Odesa Regional Clinical Hospital
  • SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
  • Private Small Enterprise Medical Center Pulse
  • Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
  • MCIC MC LLC Health Clinic
  • SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
  • CI City Clinical Hospital #6 Dept of Gastroenterology
  • SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
  • Derriford Hospital
  • Salford Royal
  • Norfolk and Norwich University Hospital
  • Glasgow Royal Infirmary
  • University Hospital Coventry
  • Royal Wolverhampton hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vedolizumab IV 300 mg

Adalimumab SC 160/80/40 mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
July 10, 2015
Last Updated
January 14, 2020
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02497469
Brief Title
An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 29, 2015 (Actual)
Primary Completion Date
September 26, 2018 (Actual)
Study Completion Date
January 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
771 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vedolizumab IV 300 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Adalimumab SC 160/80/40 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab
Intervention Description
Vedolizumab infusion
Intervention Type
Drug
Intervention Name(s)
Adalimumab placebo
Intervention Description
Adalimumab placebo-matching injection
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
Adalimumab injection
Intervention Type
Drug
Intervention Name(s)
Vedolizumab placebo
Intervention Description
Vedolizumab placebo-matching infusion
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Clinical Remission
Description
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).
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Mucosal Healing
Description
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).
Time Frame
Week 52
Title
Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission
Description
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).
Time Frame
Week 52

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35934286
Citation
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.
Results Reference
derived
PubMed Identifier
34144047
Citation
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.
Results Reference
derived
PubMed Identifier
31553834
Citation
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.
Results Reference
derived

Learn more about this trial

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

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