Clinical trial NCT02674308: Entyvio (Vedolizumab) Long Term Safety Study
Official title: Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis and Crohn's Disease
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 5302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating Entyvio or another biologic agent. Participants may be biologic-naive or have prior use of a biologic agent

Brief summary: The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

Detailed description: The drug being tested in this prospective, observational study is called vedolizumab. Vedolizumab is being used to treat people who have UC or CD. This study will look at the long-term safety of vedolizumab versus other biologic agents in participants with UC or CD. The study will enroll approximately 5000 participants. All participants enrolled in this will belong to one of the two treatment group:

* Vedolizumab
* Other Biologic Agents -adalimumab, certolizumab pegol.

Golimumab and infliximab. Study drugs will be prescribed by the physician according to local prescribing information in the participating countries. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is 7 years. Participants will make visits at every 6 months to their treating physician.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, by the participant or a legally acceptable representative.
2. Aged at least 18 years.
3. Initiating vedolizumab or another biologic agent for UC or CD.
4. Signed release form, by the participant or a legally acceptable representative, permitting abstraction of the participant's medical records at Baseline and during participation in the study.

Exclusion Criteria:

1. The participant is enrolled in a clinical trial in which treatment for CD or UC is managed through a protocol.
2. Prior treatment with vedolizumab.
3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Primary outcomes:
measure: Percentage of Participants with Adverse Events of Special Interest
timeFrame: 7 years
Secondary outcomes:
measure: Disease Severity in Ulcerative Colitis (UC) Participants
timeFrame: Baseline and at every 6 months (up to 7 years)
measure: Disease Severity in Crohn's Disease (CD) Participants
timeFrame: Baseline and at every 6 months (up to 7 years)
measure: Participant Reported Quality of Life Assessment Using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
timeFrame: Baseline and at every 6 months (up to 7 years)
measure: Participant Reported Quality of Life Assessment Using 12-Item Short Form Health Survey (SF-12)
timeFrame: Baseline and at every 6 months (up to 7 years)
measure: Time to Treatment Discontinuation
timeFrame: Baseline and at every 6 months (up to 7 years)
measure: Reasons for Treatment Discontinuation
timeFrame: Baseline and at every 6 months (up to 7 years)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Torrance
country: United States
facility: South Bay Gastroenterology Medical Group
state: California
city: Hamden
country: United States
facility: Gastroenterology Center of Connecticut P.C.
state: Connecticut
city: Middletown
country: United States
facility: Middlesex Gastroenterology Associates, Llc
state: Connecticut
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Pensacola
country: United States
facility: Gulf Region Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital, the Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Gastroenterology Groupllc Northwest Gastroenterologists
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore University Health Systems
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Digestive Health Center
state: Kansas
city: Wichita
country: United States
facility: Kansas Gastroenterology
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Metairie
country: United States
facility: New Orleans Research Institute
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, Llc
state: Louisiana
city: Boston
country: United States
facility: Crohn'S and Colitis Center
state: Massachusetts
city: Boston
country: United States
facility: Boston University Moakley Building Center For Digestive Disorders
state: Massachusetts
city: Worcester
country: United States
facility: Umass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Infusion Associates, Grand Rapids
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Ocean Spring
country: United States
facility: Digestive Health Center, Pa
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Chi Health Alegent Creighton Clinic
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Englewood
country: United States
facility: Englewood Endoscopic Associates
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Burnt Hills
country: United States
facility: Saratoga-Schenectady Gastroenterology Associates
state: New York
city: Fishkill
country: United States
facility: Digestive Disease Center
state: New York
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Great Neck
country: United States
facility: Nyu Langone Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Nyu Langone Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine At Mount Sinai
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Rochester
country: United States
facility: Gastroenterology Group of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greenville
country: United States
facility: Carolina Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Trihealth Digestive Institute
state: Ohio
city: Philadelphia
country: United States
facility: Mark Osterman
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia Va Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Consultants in Gastroenterology - Columbia
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Sam Houston
country: United States
state: Texas
city: Houston
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Ut Health Science Center
state: Texas
city: Humble
country: United States
facility: Spring Gastroenterology
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Oberosterreich
country: Austria
facility: Krankenhaus Der Elisabethinen Linz Gmbh
city: Ried Im Innkreis
country: Austria
facility: Kh Der Barmherzigen Schwestern
city: Salzburg
country: Austria
facility: Ordination Dr. Thomas Haas Darmpraxis Salzburg
city: Salzburg
country: Austria
facility: Salk Salzburg
city: St. Poelten
country: Austria
facility: Landesklinikum St. Poelten
city: Wels
country: Austria
facility: KH WELS
city: Wien
country: Austria
facility: Medizinischen Universitat Wien - Allgemeines Krankenhaus (Akh) - Universitaetsklinik Fuer Innere Medizin Iii
city: Wien
country: Austria
facility: Loha For Life
city: Aalst
country: Belgium
facility: Olv Aalst - Gastro-Enterologie
city: Bonheiden
country: Belgium
facility: Imelda - Gastro-Enterologie
city: Brussels
country: Belgium
facility: Chu Saint Pierre - Service de Gastroenterologie
city: Brussels
country: Belgium
facility: Cub Hopital Erasme
city: Brussels
country: Belgium
facility: Uz Brussel - Gastro-Enterologie
city: Bruxelles
country: Belgium
facility: HIS-IZZ
city: Edegem
country: Belgium
facility: Uz Antwerpen - Gastro-Enterologie
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg - Gastro-Enterologie
city: Gent
country: Belgium
facility: Az Maria Middelares - Gastro-Enterologie
city: Gent
country: Belgium
facility: Az St Lucas - Gastro-Enterologie
city: Gent
country: Belgium
facility: Uz Gent - Gastro-Enterologie
city: Hasselt
country: Belgium
facility: Jessa Ziekenhus - Gastro-Enterologie
city: Kortrijk
country: Belgium
facility: Az Groeninge - Campus Kennedylaan - Gastro-Enterologie
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen (Uz) Leuven - Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Chretien (Chc) - Clinique Saint-Joseph (Hopital St-Joseph) - Gastro-Enterologie
city: Liege
country: Belgium
facility: Chr de La Citadelle
city: Liege
country: Belgium
facility: Chu Liege - Gastro-Enterologie
city: Mechelen
country: Belgium
facility: Az Sint Maarten, Campus Rooienberg
city: Mons
country: Belgium
facility: Chu Ambroise-Pare
city: Namur
country: Belgium
facility: Clinique Et Maternite Sainte-Elisabeth
city: Ottignies
country: Belgium
facility: Clinique St Pierre Asbl
city: Roeselare
country: Belgium
facility: Az Delta - Gastro-Enterologie
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie Picardie, Site Notre Dame
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials Ltd.
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMasters University
state: Ontario
city: North Bay
country: Canada
facility: Scott Shulman Medical Prof. Corp
state: Ontario
city: Oshawa
country: Canada
facility: Taunton Surgical Centre-Oshawa Clinic
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto - St. Michaels Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Osijek
country: Croatia
facility: University Hospital Center Osijek
city: Split
country: Croatia
facility: Clinical Hospital Centre Split
city: Split
country: Croatia
facility: Kbc Split
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Aalborg
country: Denmark
facility: University Hospital, Aalborg
city: Copenhagen Nv
country: Denmark
facility: Bispebjerg Univarsity Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Abdominal Centre
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Nykobing Falster
country: Denmark
facility: Nykobing Falster Sygehus
city: Silkeborg
country: Denmark
facility: Silkeborg Hospital
city: Tallinn
country: Estonia
facility: West-Tallinn Central Hospital (Ltkh)
city: Tallinn
country: Estonia
facility: North Estonian Regional Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Amiens
country: France
facility: Chu Amiens Picardie - Service Hepato-Gastro-Enterologie
city: Angers
country: France
facility: C H U Angers
city: Bobigny
country: France
facility: Hopital Avicenne
city: Caen Cedex
country: France
facility: Centre Hospitalier Universitaire (Chu) de Caen - Service D'Hepatogastroenterologie
city: Chambray-les-tours
country: France
facility: C.H.U de Tours - Hopital Trousseau
city: Clermont Ferrand
country: France
facility: Chu de Clermont Ferrand - Hopital Estaing
city: Colmar Cedex
country: France
facility: Hopitaux Civils de Colmar
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire (Chru) de Lille - Hopital Claude Huriez
city: Lyon
country: France
facility: Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot
city: Marseille
country: France
facility: Chu Hopital Nord, Marseille - Service D'Hepato-Gastro-Enterologie
city: Montpellier
country: France
facility: University Hospital St Eloi
city: Nice
country: France
facility: Centre Hospitalier Universitaire (Chu) de Nice - Hopital L'Archet 2 - Pole Digestif
city: Nimes
country: France
facility: Chu Nimes - Hopital Caremeau
city: Paris Cedex 14
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Centre Hospitalo Universitaire (Chu) - Hopital Saint-Antoine
city: Pessac Cedex
country: France
facility: Hopital Du Haut Leveque - Service D'Hepato-Gastro-Enterologie Et Nutritution, Unite de Soin Normalise
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon (Hcl) - Centre Hospitalier Lyon-Sud - Hepatogastroenterologie
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Reims
country: France
facility: Chu de Reims - Hopital Robert Debre
city: Rouen
country: France
facility: Centre Hospitalier Universitaire (Chu) de Rouen
city: Saint-etienne
country: France
facility: Service Gastro-Enterologie Hopital Nord - Chu de Saint Etienne
city: Toulouse Cedex 9
country: France
facility: Hopital Rangueil - Service de Gastroenterologie
city: Tourcoing Cedex
country: France
facility: Ch Gustave Dron - Hopital de Tourcoing
city: Valenciennes
country: France
facility: Ch Valenciennes - Hopital Jean Bernard - Service Maladies de L'Appareil Digestif Et de La Nutrition
city: Amberg
country: Germany
facility: Praxis Dr. Med. Eberhard Meier
city: Berlin
country: Germany
facility: Charite Campus Campus Mitte
city: Berlin
country: Germany
facility: Praxis Dr. Mross
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Cbf) - Medizinische Klinik I
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum - Medizinische Klinik Mit Schwerpunkt Hepatologie Und Gastroenterologie
city: Berlin
country: Germany
facility: Praxis Fur Gastroenterologie Am Bayerischen Platz
city: Biberach
country: Germany
facility: Sana Klinik Biberach
city: Dachau
country: Germany
facility: Medizinisches Versorgungszentrum (Mvz) Dachau
city: DESSAU-ROsLAU
country: Germany
facility: Stadtisches Klinikum Dessau
city: Dresden
country: Germany
facility: Technische Universitaet Dresden - Universitaetklinikum Carl Gustav Carus - Medizinische Klinik Und Poliklinik I
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen Medizinische Klinik I - Studien Ambulanz Ced
city: Essen
country: Germany
facility: St. Josef Krankenhaus Essen-Werden / Abteilung Fur Gastroenterologie
city: Frankfurt Am Main
country: Germany
facility: Crohn-Colitis Centrum Rhein-Main
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus, Medizinische Klinik 1
city: Halle (saale)
country: Germany
facility: Praxis Dr. Med. Thomas Zeisler
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle Dolau Ggmbii, Klinik Fur Innere Medizin I
city: Halle
country: Germany
facility: Universitatsklinik Und Poliklinik Fur Innere Medizin I
city: Hamburg Eppendorf
country: Germany
facility: Hafced E.K.
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Heidelberg
country: Germany
facility: Praxis Fur Gastroenterologie
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Dr. Felten
city: Jerichow
country: Germany
facility: Praxis Group
city: Kothen
country: Germany
facility: PRAXIS
city: Leipzig
country: Germany
facility: Eugastro Gmbh
city: Leipzig
country: Germany
facility: Universitat Leipzig, Medizinische Fakultat
city: Leipzig
country: Germany
facility: Gesellschaft Fuer Klinische Studien
city: Ludwigshafen Am Rhein
country: Germany
facility: St. Marien Krankenhauses - Medizinischen Klinik I
city: Luneburg
country: Germany
facility: Staedtisches Klinikum Luneburg
city: Magdeburg
country: Germany
facility: Universitatsklinikum Magdeburg A. O. R. - Klinik Fur Gastroenterologie
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz, I.Med.Klinik, Geb.605, Eg, Zi.0240
city: Mannheim
country: Germany
facility: Gastroenterologische Schwerpunkt Praxis
city: Mannheim
country: Germany
facility: Praxis Dr. Krammer
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Munchen
country: Germany
facility: Klinikum Der Universitat Munchen
city: Munster
country: Germany
facility: Medizinische Versorgungszentrum Portal 10
city: Munster
country: Germany
facility: Gastroenterologische Fachpraxis Am Germania Campus
city: Nurnberg
country: Germany
facility: Praxis Group
city: Regensburg
country: Germany
facility: Praxiszentrum Alte Malzerei
city: Remscheid
country: Germany
facility: Eric Norgaard Jorgensen
city: Russelsheim
country: Germany
facility: Gpr Mvz Gastroenterologie
city: Saarbrucken
country: Germany
facility: Gemeinschaftspraxis - Endoskopiezentrum M. Hasenstein
city: Stade
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis - Stade
city: Tubingen
country: Germany
facility: Uni-Klinik Tubingen
city: Wiesbaden
country: Germany
facility: Gastro Data Gbr
city: Alexandroupoli
country: Greece
facility: University and General Hospital of Alexandroupoli
city: Athens
country: Greece
facility: General Hospital of Athens 'Evangelismos'
city: Athens
country: Greece
facility: General and University Hospital of Western Athens 'Attiko'
city: Athens
country: Greece
facility: St. Panteleimon General Hospital of Nikaia
city: Heraklion
country: Greece
facility: University and General Hospital of Heraklion
city: Ioannina
country: Greece
facility: University Hospital of Ioannina - Division of Gastroenterology
city: Thessaloniki
country: Greece
facility: Theagenio Hospital of Thessaloniki
city: Cork
country: Ireland
facility: Mercy University Hospital Cork
city: Dublin 4
country: Ireland
facility: St. Vincent'S University Hospital
city: Dublin 7
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin 8
country: Ireland
facility: St James Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: National University of Ireland Galway
city: Afula
country: Israel
facility: Haemek Medical Center
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center (Sumc)
city: Haifa
country: Israel
facility: Rambam Health Care Campus (Rhcc) - Institute of Gastroenterology
city: Haifa
country: Israel
facility: Bnai Zion Mc
city: Jerusalem
country: Israel
facility: Clalit Health Services - Lev Talpiot
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Tel Aviv University - Rabin Medical Center - Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Clalit Medical Services - Migdal Hamea
city: Tel Aviv
country: Israel
facility: Maccabi Healthcare Services
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Zrifin
country: Israel
facility: Assaf Harofeh Medical Center (Ahmc) - Institute of Gastroenterology
city: Avellino Campania
country: Italy
facility: Ospedale Civile Giuseppe Moscati
city: Brescia
country: Italy
facility: Spedali Civili Gastroenterology Unit University of Brescia
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Catania
country: Italy
facility: Azienda Ospedaliera Per Lemergenza Cannizzaro
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)
city: Foggia 0301
country: Italy
facility: Casa Sollievo Della Sofferenza
city: Forli
country: Italy
facility: Ospedale Morgagni Pierantoni Forli U.O. Gastroenterologia Ed Endoscopia
city: Messina
country: Italy
facility: Policlinico G Martino
city: Milano 3901
country: Italy
facility: Asst Fatebenefratelli Sacco
city: Milano
country: Italy
facility: A.O. Guido Salvini Di Garbagnate Milanese
city: Milano
country: Italy
facility: Fondazione Irccs Ca' Granda Osp Magg Policlinico
city: Napoli 2007
country: Italy
facility: Universita Federico Ii
city: Novara
country: Italy
facility: Ospedale Maggiore Della Carita
city: Palermo
country: Italy
facility: Policlicnico Universita Paolo Giaccone
city: Roma
country: Italy
facility: Ao San Camillo Forlanini
city: Roma
country: Italy
facility: Ospedale Nuovo Regina Margherita
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
city: Rome
country: Italy
facility: Universita Campus Bio-Medico
city: Rome
country: Italy
facility: Policlinico Tor Vergata
city: Salerno
country: Italy
facility: Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona
city: Torino
country: Italy
facility: Ao Ordine Mauriziano Di Torino
city: Varese
country: Italy
facility: Osp Di Circolo Fondazione Macchi
city: Amsterdam
country: Netherlands
facility: VUMC
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Mdl
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Mc
city: Sittard
country: Netherlands
facility: Zuyderland
city: Bodo
country: Norway
facility: Nordlandssykehuset Hf Bodo
city: Hamar
country: Norway
facility: Sykehuset Innlandet Hf Hamar
city: Nordbyhagen
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo Univeristy Hospital Ulleval Hospital
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, Epe
city: Celje
country: Slovenia
facility: General Hospital Celje
city: Maribor
country: Slovenia
facility: University Medical Center Maribor
city: Badalona
country: Spain
facility: Hospital Univ. Germans Trias I Pujol
city: Hospitalet
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: Complexo H. Pontevedra-Hospital de Montecelo
city: Terrasa
country: Spain
facility: Consorci Sanitari de Terrassa
city: Vigo
country: Spain
facility: H. Alvaro Cunqueiro
city: Stockholm
country: Sweden
facility: Medical Dept, Gastroenterology Unit
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus Ab
city: Bern
country: Switzerland
facility: Universitaetsspital Bern - Inselspital - Universitaetsklinik Fuer Viszerale Chirurgie Und Medizin (Uvcm) - Klinik Und Poliklinik Fuer Gastroenterologie
city: Bern
country: Switzerland
facility: Gastroenterologische Praxis Balsiger, Seibold & Partner Crohn-Colitis-Zentrum Hochhaus Lindenhofspital
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen - Gastroenterologie
city: Zurich
country: Switzerland
facility: Universitatspital Zurich
city: Abergavenny
country: United Kingdom
facility: Nevill Hall Hospital - Aneurin Bevan Health Board
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital (Bvh) - Gastroenterology Department
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals
city: Camberley
country: United Kingdom
facility: Frimley Park Hospital
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire Nhs Trust - University Hospital (Walsgrave Hospital)
city: Derby
country: United Kingdom
facility: Derby Hospitals Nhs Foundation Trust - Royal Derby Hospital (Derby City General Hospital)
city: Harrow
country: United Kingdom
facility: The North West London Hospitals Nhs Trust (Nwlh) - St Mark'S Hospital
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Nhs Trust
city: Keighley
country: United Kingdom
facility: Airedale Nhs Foundation Trust
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Barts Health Nhs Trust
city: London
country: United Kingdom
facility: Nhs Foundation Trust - Homerton University Hospital (Huh)
city: London
country: United Kingdom
facility: King'S College Hospital (Kch) Nhs Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
city: Nottingham
country: United Kingdom
facility: The University of Nottingham - Nottingham Digestive Diseases Centre (Nddc) (Wolfson Digestive Diseases Centre)
city: Salford
country: United Kingdom
facility: Salford Royal Nhs Foundation Trust
city: Sheffield
country: United Kingdom
facility: University of Sheffield - Sheffield Teaching Hospitals Nhs Foundation Trust - Royal Hallamshire Hospital (Rhh)
city: Shrewsbury
country: United Kingdom
facility: The Shrewsbury and Telford Hospital Nhs Trust - Royal Shrewsbury Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton Nhs Foundation Trust
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital - Mid Yorkshire Hospital Trust
city: Weston-super-mare
country: United Kingdom
facility: Nhs Trust - Weston Area Health - Weston General Hospital
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Hospitals Nhs Trust - New Cross Hospital
city: Worthing
country: United Kingdom
facility: Western Sussex Hospitals Nhs Trust - Worthing Hospital
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: