AzTrials
AzTrials

Ulcerative Colitis and Crohn's DiseaseEntyvio PASSNCT02674308

Entyvio (Vedolizumab) Long Term Safety Study

An observational study of Ulcerative Colitis and Crohn's Disease, run by Takeda at 287 sites in 21 countries.

Completed

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

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis and Crohn's Disease
What is being tested?
Vedolizumab and Other Biologic Agents
How many people
5,302 participants
Where
287 sitesin 21 countries
Study dates
24 Mar 2015to 30 Jul 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

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

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Signed informed consent, by the participant or a legally acceptable representative.
  • Aged at least 18 years.
  • Initiating vedolizumab or another biologic agent for UC or CD.
  • 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.

Who cannot join

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

Trial locations and contacts

287 sites in 21 countries.

287 sites in 21 countries

United States66 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Illinois Gastroenterology Groupllc Northwest Gastroenterologists

    Arlington Heights, Illinois, 60005

  • Emory University Hospital, the Emory Clinic

    Atlanta, Georgia, 30322

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Georgia Regents University

    Augusta, Georgia, 30904

  • University of Alabama

    Birmingham, Alabama, 35294

  • Crohn'S and Colitis Center

    Boston, Massachusetts, 02114

  • Boston University Moakley Building Center For Digestive Disorders

    Boston, Massachusetts, 02118

  • Saratoga-Schenectady Gastroenterology Associates

    Burnt Hills, New York, 12027

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Trihealth Digestive Institute

    Cincinnati, Ohio, 45242

  • Consultants in Gastroenterology - Columbia

    Columbia, South Carolina, 29203

  • Englewood Endoscopic Associates

    Englewood, New Jersey, 07631

  • Northshore University Health Systems

    Evanston, Illinois, 60201

  • Digestive Disease Center

    Fishkill, New York, 12524

  • Study site

    Fort Sam Houston, Texas, 78234

  • Infusion Associates, Grand Rapids

    Grand Rapids, Michigan, 48525

  • Northwell Health

    Great Neck, New York, 11021

  • Nyu Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Carolina Research

    Greenville, North Carolina, 27834

  • Gastroenterology Center of Connecticut P.C.

    Hamden, Connecticut, 06518

  • Baylor University Medical Center

    Houston, Texas, 77030

  • Ut Health Science Center

    Houston, Texas, 77030

  • Spring Gastroenterology

    Humble, Texas, 77338

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Scripps Clinic

    La Jolla, California, 92037

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Louisville

    Louisville, Kentucky, 40202

  • Loyola University

    Maywood, Illinois, 53226

  • New Orleans Research Institute

    Metairie, Louisiana, 70006

  • Middlesex Gastroenterology Associates, Llc

    Middletown, Connecticut, 06457

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of South Alabama

    Mobile, Alabama, 36688

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Nyu Langone Medical Center

    New York, New York, 10016

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029

  • Lenox Hill Hospital

    New York, New York, 10075

  • Southwest Gastroenterology

    Oak Lawn, Illinois, 60453

  • Digestive Health Center, Pa

    Ocean Spring, Mississippi, 39564

  • Chi Health Alegent Creighton Clinic

    Omaha, Nebraska, 68124

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Stanford University

    Palo Alto, California, 94304

  • Gulf Region Clinical Research Institute

    Pensacola, Florida, 32514

  • Mark Osterman

    Philadelphia, Pennsylvania, 19104

  • Philadelphia Va Medical Center

    Philadelphia, Pennsylvania, 19104

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Gastroenterology Group of Rochester

    Rochester, New York, 14618

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Louisiana Research Center, Llc

    Shreveport, Louisiana, 71106

  • St. Louis University

    St Louis, Missouri, 63104

  • Washington University

    St Louis, Missouri, 63110

  • Atlanta Gastroenterology Associates

    Suwanee, Georgia, 30024

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas, 66606

  • South Bay Gastroenterology Medical Group

    Torrance, California, 90505

  • University of Arizona Medical Center

    Tucson, Arizona, 85724

  • Kansas Gastroenterology

    Wichita, Kansas, 67226

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

  • Umass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Germany46 sites

  • Praxis Dr. Med. Eberhard Meier

    Amberg, 92224

  • Charite Campus Campus Mitte

    Berlin, 10117

  • Praxis Dr. Mross

    Berlin, 10318

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Cbf) - Medizinische Klinik I

    Berlin, 12203

  • Charite Campus Virchow Klinikum - Medizinische Klinik Mit Schwerpunkt Hepatologie Und Gastroenterologie

    Berlin, 13353

  • Praxis Fur Gastroenterologie Am Bayerischen Platz

    Berlin, 14169

  • Sana Klinik Biberach

    Biberach, 88400

  • Medizinisches Versorgungszentrum (Mvz) Dachau

    Dachau, 85221

  • Stadtisches Klinikum Dessau

    DESSAU-ROsLAU, 06847

  • Technische Universitaet Dresden - Universitaetklinikum Carl Gustav Carus - Medizinische Klinik Und Poliklinik I

    Dresden, 01307

  • Universitatsklinikum Erlangen Medizinische Klinik I - Studien Ambulanz Ced

    Erlangen, 91054

  • St. Josef Krankenhaus Essen-Werden / Abteilung Fur Gastroenterologie

    Essen, 45239

  • Agaplesion Markus Krankenhaus, Medizinische Klinik 1

    Frankfurt, 60431

  • Crohn-Colitis Centrum Rhein-Main

    Frankfurt am Main, 60594

  • Praxis Dr. Med. Thomas Zeisler

    Halle, 06108

  • Krankenhaus Martha-Maria Halle Dolau Ggmbii, Klinik Fur Innere Medizin I

    Halle, 06120

  • Universitatsklinik Und Poliklinik Fur Innere Medizin I

    Halle, 06120

  • Asklepios Westklinikum Hamburg

    Hamburg, 22559

  • Hafced E.K.

    Hamburg Eppendorf, 20251

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • Praxis Fur Gastroenterologie

    Heidelberg, 69121

  • Gastroenterologische Gemeinschaftspraxis Dr. Felten

    Herne, 44623

  • Praxis Group

    Jerichow, 39319

  • PRAXIS

    Köthen, 06366

  • Eugastro Gmbh

    Leipzig, 04103

  • Universitat Leipzig, Medizinische Fakultat

    Leipzig, 04103

  • Gesellschaft Fuer Klinische Studien

    Leipzig, 04105

  • St. Marien Krankenhauses - Medizinischen Klinik I

    Ludwigshafen am Rhein, 67067

  • Staedtisches Klinikum Luneburg

    Lüneburg, 21339

  • Universitatsklinikum Magdeburg A. O. R. - Klinik Fur Gastroenterologie

    Magdeburg, 39120

  • Universitaetsmedizin Mainz, I.Med.Klinik, Geb.605, Eg, Zi.0240

    Mainz, 55131

  • Gastroenterologische Schwerpunkt Praxis

    Mannheim, 68161

  • Praxis Dr. Krammer

    Mannheim, 68165

  • Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik

    Mannheim, 68167

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Klinikum Der Universitat Munchen

    München, 81377

  • Medizinische Versorgungszentrum Portal 10

    Münster, 48155

  • Gastroenterologische Fachpraxis Am Germania Campus

    Münster, 48159

  • Praxis Group

    Nuremberg, 90449

  • Praxiszentrum Alte Malzerei

    Regensburg, 93053

  • Eric Norgaard Jorgensen

    Remscheid, 42859

  • Gpr Mvz Gastroenterologie

    Rüsselsheim am Main, 65428

  • Gemeinschaftspraxis - Endoskopiezentrum M. Hasenstein

    Saarbrücken, 66113

  • Gastroenterologische Gemeinschaftspraxis - Stade

    Stade, 21682

  • Uni-Klinik Tubingen

    Tübingen, 72076

  • Gastro Data Gbr

    Wiesbaden, 65189

Other trials in Germany

United Kingdom25 sites

  • Nevill Hall Hospital - Aneurin Bevan Health Board

    Abergavenny, NP7 7EG

  • Blackpool Victoria Hospital (Bvh) - Gastroenterology Department

    Blackpool, FY3 8NR

  • Bradford Teaching Hospitals

    Bradford, BD9 6RJ

  • Frimley Park Hospital

    Camberley, GU14 7UJ

  • University Hospitals Coventry and Warwickshire Nhs Trust - University Hospital (Walsgrave Hospital)

    Coventry, CV2 2DX

  • Derby Hospitals Nhs Foundation Trust - Royal Derby Hospital (Derby City General Hospital)

    Derby, DE22 3NE

  • The North West London Hospitals Nhs Trust (Nwlh) - St Mark'S Hospital

    Harrow, HA1 3UJ

  • Hull and East Yorkshire Nhs Trust

    Hull, HU32JZ

  • Airedale Nhs Foundation Trust

    Keighley, BD20 6TD

  • Forth Valley Royal Hospital

    Larbert, FK5 4WR

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Barts Health Nhs Trust

    London, E11 1NR

  • Nhs Foundation Trust - Homerton University Hospital (Huh)

    London, E9 6SR

  • King'S College Hospital (Kch) Nhs Foundation Trust

    London, SE5 9RS

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • Royal Gwent Hospital

    Newport, NP20 2UB

  • The University of Nottingham - Nottingham Digestive Diseases Centre (Nddc) (Wolfson Digestive Diseases Centre)

    Nottingham, NG7 2UH

  • Salford Royal Nhs Foundation Trust

    Salford, M6 8HD

  • University of Sheffield - Sheffield Teaching Hospitals Nhs Foundation Trust - Royal Hallamshire Hospital (Rhh)

    Sheffield, S10 2JF

  • The Shrewsbury and Telford Hospital Nhs Trust - Royal Shrewsbury Hospital

    Shrewsbury, SY3 8XQ

  • University Hospital Southampton Nhs Foundation Trust

    Southampton, SO16 6YD

  • Pinderfields Hospital - Mid Yorkshire Hospital Trust

    Wakefield, WF1 4DG

  • Nhs Trust - Weston Area Health - Weston General Hospital

    Weston-super-Mare, BS23 4TQ

  • The Royal Wolverhampton Hospitals Nhs Trust - New Cross Hospital

    Wolverhampton, WV6 9AT

  • Western Sussex Hospitals Nhs Trust - Worthing Hospital

    Worthing, BN11 2DH

Other trials in United Kingdom

France24 sites

  • Chu Amiens Picardie - Service Hepato-Gastro-Enterologie

    Amiens, 80054

  • C H U Angers

    Angers, 49033

  • Hopital Avicenne

    Bobigny, 93000

  • Centre Hospitalier Universitaire (Chu) de Caen - Service D'Hepatogastroenterologie

    Caen, 14033

  • C.H.U de Tours - Hopital Trousseau

    Chambray-lès-Tours, 37170

  • Chu de Clermont Ferrand - Hopital Estaing

    Clermont-Ferrand, 63000

  • Hopitaux Civils de Colmar

    Colmar, 68024

  • Centre Hospitalier Regional Universitaire (Chru) de Lille - Hopital Claude Huriez

    Lille, 59037

  • Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot

    Lyon, 69003

  • Chu Hopital Nord, Marseille - Service D'Hepato-Gastro-Enterologie

    Marseille, 13015

  • University Hospital St Eloi

    Montpellier, 34295

  • Centre Hospitalier Universitaire (Chu) de Nice - Hopital L'Archet 2 - Pole Digestif

    Nice, 06202

  • Chu Nimes - Hopital Caremeau

    Nîmes, 30029

  • Centre Hospitalo Universitaire (Chu) - Hopital Saint-Antoine

    Paris, 75012

  • Institut Mutualiste Montsouris

    Paris, 75674

  • Hopital Du Haut Leveque - Service D'Hepato-Gastro-Enterologie Et Nutritution, Unite de Soin Normalise

    Pessac, 33604

  • Hospices Civils de Lyon (Hcl) - Centre Hospitalier Lyon-Sud - Hepatogastroenterologie

    Pierre-Bénite, 69495

  • Centre Hospitalier Annecy Genevois

    Pringy, 74374

  • Chu de Reims - Hopital Robert Debre

    Reims, 51100

  • Centre Hospitalier Universitaire (Chu) de Rouen

    Rouen, 76031

  • Service Gastro-Enterologie Hopital Nord - Chu de Saint Etienne

    Saint-Etienne, 42000

  • Hopital Rangueil - Service de Gastroenterologie

    Toulouse, 31059

  • Ch Gustave Dron - Hopital de Tourcoing

    Tourcoing, 59208

  • Ch Valenciennes - Hopital Jean Bernard - Service Maladies de L'Appareil Digestif Et de La Nutrition

    Valenciennes, 59322

Other trials in France

Italy24 sites

  • Ospedale Civile Giuseppe Moscati

    Avellino Campania, 83100

  • Spedali Civili Gastroenterology Unit University of Brescia

    Brescia, 25123

  • Fondazione Poliambulanza

    Brescia, 25124

  • Azienda Ospedaliera Per Lemergenza Cannizzaro

    Catania, 95126

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Florence, 50134

  • Casa Sollievo Della Sofferenza

    Foggia, 71013

  • Ospedale Morgagni Pierantoni Forli U.O. Gastroenterologia Ed Endoscopia

    Forlì, 47121

  • Policlinico G Martino

    Messina, 98125

  • A.O. Guido Salvini Di Garbagnate Milanese

    Milan, 20017

  • Fondazione Irccs Ca' Granda Osp Magg Policlinico

    Milan, 20122

  • Asst Fatebenefratelli Sacco

    Milan, 20157

  • Universita Federico Ii

    Naples, 80131

  • Ospedale Maggiore Della Carita

    Novara, 28100

  • Policlicnico Universita Paolo Giaccone

    Palermo, 90127

  • Ao San Camillo Forlanini

    Roma, 00152

  • Ospedale Nuovo Regina Margherita

    Roma, 00153

  • Ospedale Sandro Pertini

    Roma, 00157

  • Fondazione Policlinico Universitario A. Gemelli

    Roma, 00168

  • Ospedale San Filippo Neri

    Roma

  • Universita Campus Bio-Medico

    Rome, 00128

  • Policlinico Tor Vergata

    Rome, 00133

  • Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona

    Salerno, 84100

  • Ao Ordine Mauriziano Di Torino

    Torino, 10128

  • Osp Di Circolo Fondazione Macchi

    Varese, 21100

Other trials in Italy

Belgium23 sites

  • Olv Aalst - Gastro-Enterologie

    Aalst, 9300

  • Imelda - Gastro-Enterologie

    Bonheiden

  • Chu Saint Pierre - Service de Gastroenterologie

    Brussels, 1000

  • Cub Hopital Erasme

    Brussels, 1070

  • HIS-IZZ

    Brussels, 1070

  • Uz Brussel - Gastro-Enterologie

    Brussels, 1090

  • Uz Antwerpen - Gastro-Enterologie

    Edegem, 2650

  • Ziekenhuis Oost Limburg - Gastro-Enterologie

    Genk, 3600

  • Az Maria Middelares - Gastro-Enterologie

    Ghent, 9000

  • Az St Lucas - Gastro-Enterologie

    Ghent, 9000

  • Uz Gent - Gastro-Enterologie

    Ghent, 9000

  • Jessa Ziekenhus - Gastro-Enterologie

    Hasselt, 3500

  • Az Groeninge - Campus Kennedylaan - Gastro-Enterologie

    Kortrijk, 85000

  • Universitaire Ziekenhuizen (Uz) Leuven - Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Chretien (Chc) - Clinique Saint-Joseph (Hopital St-Joseph) - Gastro-Enterologie

    Liège, 4000

  • Chr de La Citadelle

    Liège, 4000

  • Chu Liege - Gastro-Enterologie

    Liège, 4000

  • Az Sint Maarten, Campus Rooienberg

    Mechelen, 2800

  • Chu Ambroise-Pare

    Mons, 7000

  • Clinique Et Maternite Sainte-Elisabeth

    Namur, 5000

  • Clinique St Pierre Asbl

    Ottignies, 1340

  • Az Delta - Gastro-Enterologie

    Roeselare, 8800

  • Centre Hospitalier de Wallonie Picardie, Site Notre Dame

    Tournai, 7500

Other trials in Belgium

Israel11 sites

  • Haemek Medical Center

    Afula, 18341

  • Soroka University Medical Center (Sumc)

    Beersheba, 84101

  • Rambam Health Care Campus (Rhcc) - Institute of Gastroenterology

    Haifa, 3.1096E+006

  • Bnai Zion Mc

    Haifa, 3339510

  • Clalit Health Services - Lev Talpiot

    Jerusalem, 9362410

  • Meir Medical Center

    Kfar Saba, 44281

  • Tel Aviv University - Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 49100

  • Clalit Medical Services - Migdal Hamea

    Tel Aviv, 6203854

  • Maccabi Healthcare Services

    Tel Aviv

  • Tel Aviv Medical Center

    Tel Aviv

  • Assaf Harofeh Medical Center (Ahmc) - Institute of Gastroenterology

    Zrifin, 70300

Other trials in Israel

Austria8 sites

  • Krankenhaus Der Elisabethinen Linz Gmbh

    Oberosterreich, 4020

  • Kh Der Barmherzigen Schwestern

    Ried im Innkreis, 4910

  • Ordination Dr. Thomas Haas Darmpraxis Salzburg

    Salzburg, 5020

  • Salk Salzburg

    Salzburg, 5020

  • Landesklinikum St. Poelten

    Sankt Pölten, 3100

  • Medizinischen Universitat Wien - Allgemeines Krankenhaus (Akh) - Universitaetsklinik Fuer Innere Medizin Iii

    Vienna, 1090

  • Loha For Life

    Vienna, 1190

  • KH WELS

    Wels, 4600

Other trials in Austria

Canada7 sites

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H2Y9

  • McMasters University

    Hamilton, Ontario, L8S 4K1

  • Okanagan Clinical Trials Ltd.

    Kelowna, British Columbia, V1Y 1Z9

  • Scott Shulman Medical Prof. Corp

    North Bay, Ontario, P1B 2H3

  • Taunton Surgical Centre-Oshawa Clinic

    Oshawa, Ontario, L1H 7K4

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • University of Toronto - St. Michaels Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Greece7 sites

  • University and General Hospital of Alexandroupoli

    Alexandroupoli, 68100

  • General Hospital of Athens 'Evangelismos'

    Athens, 10676

  • General and University Hospital of Western Athens 'Attiko'

    Athens, 12462

  • St. Panteleimon General Hospital of Nikaia

    Athens, 18454

  • University and General Hospital of Heraklion

    Heraklion, 71110

  • University Hospital of Ioannina - Division of Gastroenterology

    Ioannina, 45110

  • Theagenio Hospital of Thessaloniki

    Thessaloniki, 54639

Other trials in Greece

Netherlands7 sites

  • VUMC

    Amsterdam, 1007 MB

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC

  • Academisch Medisch Centrum - Mdl

    Amsterdam, 1105 AZ

  • Amphia Ziekenhuis

    Breda, 4818 CK

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3300 AK

  • Erasmus Mc

    Rotterdam, 3000 CA

  • Zuyderland

    Sittard, 6162 BG

Other trials in Netherlands

Denmark6 sites

  • University Hospital, Aalborg

    Aalborg, 9000

  • Rigshospitalet, Abdominal Centre

    Copenhagen, DK-2100

  • Bispebjerg Univarsity Hospital

    Copenhagen NV, 2400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Nykobing Falster Sygehus

    Nykøbing Falster, 4800

  • Silkeborg Hospital

    Silkeborg, 8600

Other trials in Denmark

Ireland6 sites

  • Mercy University Hospital Cork

    Cork

  • Beaumont Hospital

    Dublin, 9

  • Mater Misericordiae University Hospital

    Dublin

  • St James Hospital

    Dublin

  • St. Vincent'S University Hospital

    Dublin

  • National University of Ireland Galway

    Galway

Other trials in Ireland

Spain6 sites

  • Hospital Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hospital de Bellvitge

    Hospitalet, 08907

  • Hospital Universitario La Paz

    Madrid, 28046

  • Complexo H. Pontevedra-Hospital de Montecelo

    Pontevedra, 36164

  • Consorci Sanitari de Terrassa

    Terrassa, 08227

  • H. Alvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Croatia4 sites

  • University Hospital Center Osijek

    Osijek, 31000

  • Clinical Hospital Centre Split

    Split, 21000

  • Kbc Split

    Split, 21000

  • University Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Norway4 sites

  • Nordlandssykehuset Hf Bodo

    Bodø, 8092

  • Sykehuset Innlandet Hf Hamar

    Hamar, 2326

  • Akershus University Hospital

    Nordbyhagen, 1478

  • Oslo Univeristy Hospital Ulleval Hospital

    Oslo, 0424

Other trials in Norway

Switzerland4 sites

  • Universitaetsspital Bern - Inselspital - Universitaetsklinik Fuer Viszerale Chirurgie Und Medizin (Uvcm) - Klinik Und Poliklinik Fuer Gastroenterologie

    Bern, 3010

  • Gastroenterologische Praxis Balsiger, Seibold & Partner Crohn-Colitis-Zentrum Hochhaus Lindenhofspital

    Bern, 3012

  • Kantonsspital St. Gallen - Gastroenterologie

    Sankt Gallen, 9007

  • Universitatspital Zurich

    Zurich, 8091

Other trials in Switzerland

Estonia3 sites

  • West-Tallinn Central Hospital (Ltkh)

    Tallinn, 10617

  • North Estonian Regional Hospital

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Sweden3 sites

  • Medical Dept, Gastroenterology Unit

    Stockholm, 11281

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 14186

  • Danderyds Sjukhus Ab

    Stockholm, 182 88

Other trials in Sweden

Slovenia2 sites

  • General Hospital Celje

    Celje, 3000

  • University Medical Center Maribor

    Maribor, 2000

Other trials in Slovenia

Portugal1 site

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, Epe

    Lisbon, 1099-023

Other trials in Portugal

About this 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

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).

Read the 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.

Being tested
Vedolizumab, Other Biologic Agents
Keywords
Drug therapy
Medical subject headings
Colitis, Ulcerative, Crohn Disease

What participants receive

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

  • VedolizumabDrug

  • Other Biologic AgentsOther

    Other biologic agents include: Adalimumab, Certolizumab pegol, Golimumab, and Infliximab

Study groups in NCT02674308
Study groupRoleWhat they receive
VedolizumabNot described
Receives: Drug: Vedolizumab
Other Biologic AgentsNot described
Receives: Other: Other Biologic Agents

What is being measured

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

  1. Percentage of Participants with Adverse Events of Special Interest

    Adverse events of special interest in this study includes serious and opportunistic infections, gastrointestinal infections, respiratory infections, other clinically significant infections: malignancies; infusion-related reactions and hypersensitivity, hepatic injury; psoriasis and other skin events, other SAEs and adverse reactions.

    Measured: 7 years

Secondary outcomes (6)

  1. Disease Severity in Ulcerative Colitis (UC) Participants

    Disease severity will be measured using the Mayo score for ulcerative colitis and is ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician rating of disease activity, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).

    Measured: Baseline and at every 6 months (up to 7 years)

  2. Disease Severity in Crohn's Disease (CD) Participants

    Disease severity will be measured using the Harvey-Bradshaw Index (HBI) for crohn's disease. HBI is used in the assessment and quantification of symptoms and the present level of disease activity of participants with Crohn's disease. It is a validated clinical index for Crohn's disease,HBI score consists of clinical parameters of general well-being (0= very well 1=slightly below average, 2=poor, 3=very poor, 4=terrible); abdominal pain (0=none, 1=mild, 2=moderate, 3=severe); number of liquid stools per day; abdominal mass (0=none, 1=dubious, 2=definite, 3=tender); and complications (8 items: arthralgia, uveitis, erythema nodosum, aphthous ulcers, pyoderma gangrenosum, anal fissures, new fistula, abscess [score 1 per item]).Lower scores indicate better well-being. The scores are classified as: <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. Minimum score is 0 and no pre-specified maximum score as it depends on the number of liquid stools.

    Measured: Baseline and at every 6 months (up to 7 years)

  3. Participant Reported Quality of Life Assessment Using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

    The Short IBD Questionnaire is an instrument used to assess quality of life and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor quality of life) to 7 (good quality of life). A higher score indicates a better health-related quality of life.

    Measured: Baseline and at every 6 months (up to 7 years)

  4. Participant Reported Quality of Life Assessment Using 12-Item Short Form Health Survey (SF-12)

    The SF-12 health questionnaire is a 12 question assessment of functional health and well-being. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better quality of life.

    Measured: Baseline and at every 6 months (up to 7 years)

  5. Time to Treatment Discontinuation

    Time to discontinuation for Entyvio and the other biologic agents will be measured.

    Measured: Baseline and at every 6 months (up to 7 years)

  6. Reasons for Treatment Discontinuation

    Reasons for discontinuations for Entyvio and the other biologic agents will be measured.

    Measured: Baseline and at every 6 months (up to 7 years)

Timeline

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

  1. First posted4 Feb 2016 (estimated)
  2. Study start24 Mar 2015
  3. Primary completion30 Jul 2021
  4. Study completion30 Jul 2021

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02674308
Sponsor's protocol ID
MLN-0002_401
Other IDs
MLN0002-401
Acronym
Entyvio PASS
Status last verified
Oct 2024
First submitted
29 Jan 2016
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis and Crohn's Disease, run by Takeda at 287 sites in 21 countries.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 287 sites in United States, Germany, United Kingdom, France, Italy and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

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

What does the primary outcome measure?

Percentage of Participants with Adverse Events of Special Interest (time frame: 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02674308.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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