Entyvio (Vedolizumab) Long Term Safety Study (Entyvio PASS)

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).

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis and Crohn's Disease
• Intervention / Treatment: Drug: Vedolizumab; Other: Other Biologic Agents

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.

• Study Type: Observational
• Enrollment (Actual): 5302

Contacts and Locations

Study Locations

• Austria
  • Oberosterreich, Austria, 4020
    • Krankenhaus der Elisabethinen Linz GmbH
  • Ried Im Innkreis, Austria, 4910
    • KH der Barmherzigen Schwestern
  • Salzburg, Austria, 5020
    • Ordination Dr. Thomas Haas Darmpraxis Salzburg
  • Salzburg, Austria, 5020
    • Salk Salzburg
  • St. Poelten, Austria, 3100
    • Landesklinikum St. Poelten
  • Wels, Austria, 4600
    • KH WELS
  • Wien, Austria, 1090
    • Medizinischen Universitat Wien - Allgemeines Krankenhaus (Akh) - Universitaetsklinik Fuer Innere Medizin Iii
  • Wien, Austria, 1190
    • Loha For Life
• Belgium
  • Aalst, Belgium, 9300
    • Olv Aalst - Gastro-Enterologie
  • Bonheiden, Belgium
    • Imelda - Gastro-Enterologie
  • Brussels, Belgium, 1070
    • CUB Hôpital Erasme
  • Brussels, Belgium, 1000
    • Chu Saint Pierre - Service de Gastroenterologie
  • Brussels, Belgium, 1090
    • Uz Brussel - Gastro-Enterologie
  • Bruxelles, Belgium, 1070
    • HIS-IZZ
  • Edegem, Belgium, 2650
    • Uz Antwerpen - Gastro-Enterologie
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg - Gastro-Enterologie
  • Gent, Belgium, 9000
    • Az Maria Middelares - Gastro-Enterologie
  • Gent, Belgium, 9000
    • Az St Lucas - Gastro-Enterologie
  • Gent, Belgium, 9000
    • Uz Gent - Gastro-Enterologie
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhus - Gastro-Enterologie
  • Kortrijk, Belgium, 85000
    • Az Groeninge - Campus Kennedylaan - Gastro-Enterologie
  • Leuven, Flemish Brabant, Belgium, 3000
    • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
  • Liege, Belgium, 4000
    • CHR de la Citadelle
  • Liege, Belgium, 4000
    • Centre Hospitalier Chretien (Chc) - Clinique Saint-Joseph (Hopital St-Joseph) - Gastro-Enterologie
  • Liege, Belgium, 4000
    • Chu Liege - Gastro-Enterologie
  • Mechelen, Belgium, 2800
    • Az Sint Maarten, Campus Rooienberg
  • Mons, Belgium, 7000
    • CHU Ambroise-Paré
  • Namur, Belgium, 5000
    • Clinique et Maternité Sainte-Elisabeth
  • Ottignies, Belgium, 1340
    • Clinique St Pierre asbl
  • Roeselare, Belgium, 8800
    • Az Delta - Gastro-Enterologie
  • Tournai, Belgium, 7500
    • Centre Hospitalier de Wallonie Picardie, Site Notre Dame
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Okanagan Clinical Trials Ltd.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H2Y9
      • Nova Scotia Health Authority
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMasters University
    • North Bay, Ontario, Canada, P1B 2H3
      • Scott Shulman Medical Prof. Corp
    • Oshawa, Ontario, Canada, L1H 7K4
      • Taunton Surgical Centre-Oshawa Clinic
    • Toronto, Ontario, Canada, M5B 1W8
      • University of Toronto - St. Michaels Hospital
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• Croatia
  • Osijek, Croatia, 31000
    • University Hospital Center Osijek
  • Split, Croatia, 21000
    • Clinical Hospital Centre Split
  • Split, Croatia, 21000
    • KBC Split
  • Zagreb, Croatia, 10000
    • University Hospital Dubrava
• Denmark
  • Aalborg, Denmark, 9000
    • University Hospital, Aalborg
  • Copenhagen, Denmark, DK-2100
    • Rigshospitalet, Abdominal Centre
  • Copenhagen Nv, Denmark, 2400
    • Bispebjerg Univarsity Hospital
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Nykobing Falster, Denmark, 4800
    • Nykobing Falster Sygehus
  • Silkeborg, Denmark, 8600
    • Silkeborg Hospital
• Estonia
  • Tallinn, Estonia, 10617
    • West-Tallinn Central Hospital (Ltkh)
  • Tallinn, Estonia, 13419
    • North Estonian Regional Hospital
  • Tartu, Estonia, 51014
    • Tartu University Hospital
• France
  • Amiens, France, 80054
    • Chu Amiens Picardie - Service Hepato-Gastro-Enterologie
  • Angers, France, 49033
    • C H U Angers
  • Bobigny, France, 93000
    • Hôpital Avicenne
  • Caen Cedex, France, 14033
    • Centre Hospitalier Universitaire (Chu) de Caen - Service D'Hepatogastroenterologie
  • Chambray-les-tours, France, 37170
    • C.H.U de Tours - Hopital Trousseau
  • Clermont Ferrand, France, 63000
    • CHU de Clermont Ferrand - Hopital Estaing
  • Colmar Cedex, France, 68024
    • Hôpitaux civils de Colmar
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez
  • Lyon, France, 69003
    • Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot
  • Marseille, France, 13015
    • Chu Hopital Nord, Marseille - Service D'Hepato-Gastro-Enterologie
  • Montpellier, France, 34295
    • University Hospital St Eloi
  • Nice, France, 06202
    • Centre Hospitalier Universitaire (Chu) de Nice - Hopital L'Archet 2 - Pole Digestif
  • Nimes, France, 30029
    • CHU Nimes - Hopital Caremeau
  • Paris, France, 75012
    • Centre Hospitalo Universitaire (Chu) - Hopital Saint-Antoine
  • Paris Cedex 14, France, 75674
    • Institut Mutualiste Montsouris
  • Pessac Cedex, France, 33604
    • Hopital Du Haut Leveque - Service D'Hepato-Gastro-Enterologie Et Nutritution, Unite de Soin Normalise
  • Pierre Benite, France, 69495
    • Hospices Civils de Lyon (Hcl) - Centre Hospitalier Lyon-Sud - Hepatogastroenterologie
  • Pringy, France, 74374
    • Centre Hospitalier Annecy Genevois
  • Reims, France, 51100
    • CHU de Reims - Hôpital Robert Debré
  • Rouen, France, 76031
    • Centre Hospitalier Universitaire (CHU) de Rouen
  • Saint-etienne, France, 42000
    • Service Gastro-Enterologie Hopital Nord - Chu de Saint Etienne
  • Toulouse Cedex 9, France, 31059
    • Hopital Rangueil - Service de Gastroenterologie
  • Tourcoing Cedex, France, 59208
    • Ch Gustave Dron - Hopital de Tourcoing
  • Valenciennes, France, 59322
    • Ch Valenciennes - Hopital Jean Bernard - Service Maladies de L'Appareil Digestif Et de La Nutrition
• Germany
  • Amberg, Germany, 92224
    • Praxis Dr. Med. Eberhard Meier
  • Berlin, Germany, 10117
    • Charite Campus Campus Mitte
  • Berlin, Germany, 10318
    • Praxis Dr. Mroß
  • Berlin, Germany, 12203
    • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Cbf) - Medizinische Klinik I
  • Berlin, Germany, 13353
    • Charite Campus Virchow Klinikum - Medizinische Klinik Mit Schwerpunkt Hepatologie Und Gastroenterologie
  • Berlin, Germany, 14169
    • Praxis fur Gastroenterologie am Bayerischen Platz
  • Biberach, Germany, 88400
    • Sana Klinik Biberach
  • DESSAU-ROsLAU, Germany, 06847
    • Stadtisches Klinikum Dessau
  • Dachau, Germany, 85221
    • Medizinisches Versorgungszentrum (MVZ) Dachau
  • Dresden, Germany, 01307
    • Technische Universitaet Dresden - Universitaetklinikum Carl Gustav Carus - Medizinische Klinik Und Poliklinik I
  • Erlangen, Germany, 91054
    • Universitatsklinikum Erlangen Medizinische Klinik I - Studien Ambulanz Ced
  • Essen, Germany, 45239
    • St. Josef Krankenhaus Essen-Werden / Abteilung Fur Gastroenterologie
  • Frankfurt, Germany, 60431
    • Agaplesion Markus Krankenhaus, Medizinische Klinik 1
  • Frankfurt Am Main, Germany, 60594
    • Crohn-Colitis Centrum Rhein-Main
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle Dolau Ggmbii, Klinik Fur Innere Medizin I
  • Halle, Germany, 06120
    • Universitätsklinik und Poliklinik für Innere Medizin I
  • Halle (saale), Germany, 06108
    • Praxis Dr. Med. Thomas Zeisler
  • Hamburg, Germany, 22559
    • Asklepios Westklinikum Hamburg
  • Hamburg Eppendorf, Germany, 20251
    • Hafced E.K.
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Heidelberg, Germany, 69121
    • Praxis fur Gastroenterologie
  • Herne, Germany, 44623
    • Gastroenterologische Gemeinschaftspraxis Dr. Felten
  • Jerichow, Germany, 39319
    • Praxis Group
  • Kothen, Germany, 06366
    • Praxis
  • Leipzig, Germany, 04103
    • EUGASTRO GmbH
  • Leipzig, Germany, 04103
    • Universität Leipzig, Medizinische Fakultät
  • Leipzig, Germany, 04105
    • Gesellschaft Fuer Klinische Studien
  • Ludwigshafen Am Rhein, Germany, 67067
    • St. Marien Krankenhauses - Medizinischen Klinik I
  • Luneburg, Germany, 21339
    • Staedtisches Klinikum Luneburg
  • Magdeburg, Germany, 39120
    • Universitatsklinikum Magdeburg A. O. R. - Klinik Fur Gastroenterologie
  • Mainz, Germany, 55131
    • Universitaetsmedizin Mainz, I.Med.Klinik, Geb.605, Eg, Zi.0240
  • Mannheim, Germany, 68161
    • Gastroenterologische Schwerpunkt Praxis
  • Mannheim, Germany, 68165
    • Praxis Dr. Krammer
  • Mannheim, Germany, 68167
    • Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
  • Minden, Germany, 32423
    • Gastroenterologische Gemeinschaftspraxis Minden
  • Munchen, Germany, 81377
    • Klinikum der Universität München
  • Munster, Germany, 48155
    • Medizinische Versorgungszentrum Portal 10
  • Munster, Germany, 48159
    • Gastroenterologische Fachpraxis am Germania Campus
  • Nurnberg, Germany, 90449
    • Praxis Group
  • Regensburg, Germany, 93053
    • Praxiszentrum Alte Mälzerei
  • Remscheid, Germany, 42859
    • Eric Norgaard Jorgensen
  • Russelsheim, Germany, 65428
    • Gpr Mvz Gastroenterologie
  • Saarbrucken, Germany, 66113
    • Gemeinschaftspraxis - Endoskopiezentrum M. Hasenstein
  • Stade, Germany, 21682
    • Gastroenterologische Gemeinschaftspraxis - Stade
  • Tubingen, Germany, 72076
    • Uni-Klinik Tubingen
  • Wiesbaden, Germany, 65189
    • Gastro Data Gbr
• Greece
  • Alexandroupoli, Greece, 68100
    • University and General Hospital of Alexandroupoli
  • Athens, Greece, 10676
    • General Hospital of Athens 'Evangelismos'
  • Athens, Greece, 12462
    • General and University Hospital of Western Athens 'Attiko'
  • Athens, Greece, 18454
    • St. Panteleimon General Hospital of Nikaia
  • Heraklion, Greece, 71110
    • University and General Hospital of Heraklion
  • Ioannina, Greece, 45110
    • University Hospital of Ioannina - Division of Gastroenterology
  • Thessaloniki, Greece, 54639
    • Theagenio Hospital of Thessaloniki
• Ireland
  • Cork, Ireland
    • Mercy University Hospital Cork
  • Dublin, Ireland, 9
    • Beaumont Hospital
  • Dublin 4, Ireland
    • St. Vincent's University Hospital
  • Dublin 7, Ireland
    • Mater Misericordiae University Hospital
  • Dublin 8, Ireland
    • St James Hospital
  • Galway, Ireland
    • National University of Ireland Galway
• Israel
  • Afula, Israel, 18341
    • Haemek medical center
  • Beer Sheva, Israel, 84101
    • Soroka University Medical Center (Sumc)
  • Haifa, Israel, 3.1096E+006
    • Rambam Health Care Campus (Rhcc) - Institute of Gastroenterology
  • Haifa, Israel, 3339510
    • Bnai Zion Mc
  • Jerusalem, Israel, 9362410
    • Clalit Health Services - Lev Talpiot
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
  • Petach Tikva, Israel, 49100
    • Tel Aviv University - Rabin Medical Center - Beilinson Hospital
  • Tel Aviv, Israel
    • Tel Aviv Medical Center
  • Tel Aviv, Israel, 6203854
    • Clalit Medical Services - Migdal Hamea
  • Tel Aviv, Israel
    • Maccabi Healthcare Services
  • Zrifin, Israel, 70300
    • Assaf Harofeh Medical Center (Ahmc) - Institute of Gastroenterology
• Italy
  • Avellino Campania, Italy, 83100
    • Ospedale Civile Giuseppe Moscati
  • Brescia, Italy, 25123
    • Spedali Civili Gastroenterology Unit University of Brescia
  • Brescia, Italy, 25124
    • Fondazione Poliambulanza
  • Catania, Italy, 95126
    • Azienda Ospedaliera Per Lemergenza Cannizzaro
  • Firenze, Italy, 50134
    • Azienda Ospedaliero-Universitaria Careggi (Aouc)
  • Foggia 0301, Puglia, Italy, 71013
    • Casa Sollievo della Sofferenza
  • Forli, Italy, 47121
    • Ospedale Morgagni Pierantoni Forli U.O. Gastroenterologia Ed Endoscopia
  • Messina, Italy, 98125
    • Policlinico G Martino
  • Milano, Italy, 20017
    • A.O. Guido Salvini Di Garbagnate Milanese
  • Milano, Italy, 20122
    • Fondazione Irccs Ca' Granda Osp Magg Policlinico
  • Milano 3901, Lombardia, Italy, 20157
    • ASST Fatebenefratelli Sacco
  • Napoli 2007, Campania, Italy, 80131
    • Università Federico II
  • Novara, Italy, 28100
    • Ospedale Maggiore della Carita
  • Palermo, Italy, 90127
    • Policlicnico Universita Paolo Giaccone
  • Roma, Italy, 00152
    • AO San Camillo Forlanini
  • Roma, Italy, 00157
    • Ospedale Sandro Pertini
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli
  • Roma, Lazio, Italy, 00153
    • Ospedale Nuovo Regina Margherita
  • Roma, Lazio, Italy
    • Ospedale San Filippo Neri
  • Rome, Italy, 00128
    • Università Campus Bio-Medico
  • Rome, Italy, 00133
    • Policlinico Tor Vergata
  • Salerno, Italy, 84100
    • Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona
  • Torino, Italy, 10128
    • AO Ordine Mauriziano di Torino
  • Varese, Italy, 21100
    • Osp Di Circolo Fondazione Macchi
• Netherlands
  • Amsterdam, Netherlands, 1007 MB
    • VUmc
  • Amsterdam, Netherlands, 1091 AC
    • Onze Lieve Vrouwe Gasthuis
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum - Mdl
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Dordrecht, Netherlands, 3300 AK
    • Albert Schweitzer Ziekenhuis
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus MC
  • Sittard, Netherlands, 6162 BG
    • Zuyderland
• Norway
  • Bodo, Norway, 8092
    • Nordlandssykehuset Hf Bodo
  • Hamar, Norway, 2326
    • Sykehuset Innlandet HF Hamar
  • Nordbyhagen, Norway, 1478
    • Akershus University Hospital
  • Oslo, Norway, 0424
    • Oslo Univeristy Hospital Ulleval Hospital
• Portugal
  • Lisboa, Portugal, 1099-023
    • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
• Slovenia
  • Celje, Slovenia, 3000
    • General Hospital Celje
  • Maribor, Slovenia, 2000
    • University medical center Maribor
• Spain
  • Badalona, Spain, 08916
    • Hospital Univ. Germans Trias I Pujol
  • Hospitalet, Spain, 08907
    • Hospital De Bellvitge
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Pontevedra, Spain, 36164
    • Complexo H. Pontevedra-Hospital de Montecelo
  • Terrasa, Barcelona, Spain, 08227
    • Consorci Sanitari de Terrassa
  • Vigo, Spain, 36312
    • H. Álvaro Cunqueiro
• Sweden
  • Stockholm, Sweden, 11281
    • Medical Dept, Gastroenterology Unit
  • Stockholm, Sweden, 14186
    • Karolinska Universitetssjukhuset Huddinge
  • Stockholm, Sweden, 182 88
    • Danderyds sjukhus AB
• Switzerland
  • Bern, Switzerland, 3010
    • Universitaetsspital Bern - Inselspital - Universitaetsklinik Fuer Viszerale Chirurgie Und Medizin (Uvcm) - Klinik Und Poliklinik Fuer Gastroenterologie
  • Bern, Switzerland, 3012
    • Gastroenterologische Praxis Balsiger, Seibold & Partner Crohn-Colitis-Zentrum Hochhaus Lindenhofspital
  • St. Gallen, Switzerland, 9007
    • Kantonsspital St. Gallen - Gastroenterologie
  • Zurich, Switzerland, 8091
    • UniversitätSpital Zürich
• United Kingdom
  • Abergavenny, United Kingdom, NP7 7EG
    • Nevill Hall Hospital - Aneurin Bevan Health Board
  • Blackpool, United Kingdom, FY3 8NR
    • Blackpool Victoria Hospital (Bvh) - Gastroenterology Department
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Teaching Hospitals
  • Camberley, Surrey, United Kingdom, GU14 7UJ
    • Frimley Park Hospital
  • Coventry, United Kingdom, CV2 2DX
    • University Hospitals Coventry and Warwickshire Nhs Trust - University Hospital (Walsgrave Hospital)
  • Derby, United Kingdom, DE22 3NE
    • Derby Hospitals Nhs Foundation Trust - Royal Derby Hospital (Derby City General Hospital)
  • Harrow, Middlesex, United Kingdom, HA1 3UJ
    • The North West London Hospitals Nhs Trust (Nwlh) - St Mark'S Hospital
  • Hull, United Kingdom, HU32JZ
    • Hull and East Yorkshire NHS Trust
  • Keighley, United Kingdom, BD20 6TD
    • Airedale NHS Foundation Trust
  • Larbert, United Kingdom, FK5 4WR
    • Forth Valley Royal Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital
  • London, United Kingdom, E11 1NR
    • Barts Health NHS Trust
  • London, United Kingdom, E9 6SR
    • Nhs Foundation Trust - Homerton University Hospital (Huh)
  • London, United Kingdom, SE5 9RS
    • King'S College Hospital (Kch) Nhs Foundation Trust
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Infirmary
  • Newport, United Kingdom, NP20 2UB
    • Royal Gwent Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • The University of Nottingham - Nottingham Digestive Diseases Centre (Nddc) (Wolfson Digestive Diseases Centre)
  • Salford, United Kingdom, M6 8HD
    • Salford Royal NHS Foundation Trust
  • Sheffield, United Kingdom, S10 2JF
    • University of Sheffield - Sheffield Teaching Hospitals Nhs Foundation Trust - Royal Hallamshire Hospital (Rhh)
  • Shrewsbury, United Kingdom, SY3 8XQ
    • The Shrewsbury and Telford Hospital Nhs Trust - Royal Shrewsbury Hospital
  • Southampton, Hampshire, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust
  • Wakefield, United Kingdom, WF1 4DG
    • Pinderfields Hospital - Mid Yorkshire Hospital Trust
  • Weston-super-mare, AVON, United Kingdom, BS23 4TQ
    • Nhs Trust - Weston Area Health - Weston General Hospital
  • Wolverhampton, United Kingdom, WV6 9AT
    • The Royal Wolverhampton Hospitals Nhs Trust - New Cross Hospital
  • Worthing, WEST Sussex, United Kingdom, BN11 2DH
    • Western Sussex Hospitals Nhs Trust - Worthing Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University Of Alabama
    • Mobile, Alabama, United States, 36688
      • University of South Alabama
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Medical Center
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Palo Alto, California, United States, 94304
      • Stanford University
    • Torrance, California, United States, 90505-4037
      • South Bay Gastroenterology Medical Group
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Gastroenterology Center of Connecticut P.C.
    • Middletown, Connecticut, United States, 06457
      • Middlesex Gastroenterology Associates, Llc
  • Florida
    • Naples, Florida, United States, 34102
      • Gastroenterology Group of Naples
    • Orlando, Florida, United States, 32803
      • Florida Hospital Orlando
    • Pensacola, Florida, United States, 32514
      • Gulf Region Clinical Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital, The Emory Clinic
    • Augusta, Georgia, United States, 30904
      • Georgia Regents University
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Associates
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Illinois Gastroenterology Groupllc Northwest Gastroenterologists
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health Systems
    • Maywood, Illinois, United States, 53226
      • Loyola University
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Digestive Health Center
    • Wichita, Kansas, United States, 67226
      • Kansas Gastroenterology
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • New Orleans Research Institute
    • Shreveport, Louisiana, United States, 71106
      • Louisiana Research Center, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Crohn'S and Colitis Center
    • Boston, Massachusetts, United States, 02118
      • Boston University Moakley Building Center For Digestive Disorders
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Grand Rapids, Michigan, United States, 48525
      • Infusion Associates, Grand Rapids
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Mississippi
    • Ocean Spring, Mississippi, United States, 39564
      • Digestive Health Center, Pa
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
    • Saint Louis, Missouri, United States, 63104
      • St. Louis University
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • CHI Health Alegent Creighton Clinic
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Endoscopic Associates
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • Burnt Hills, New York, United States, 12027
      • Saratoga-Schenectady Gastroenterology Associates
    • Fishkill, New York, United States, 12524
      • Digestive Disease Center
    • Great Neck, New York, United States, 11021
      • Northwell Health
    • Great Neck, New York, United States, 11021
      • NYU Langone Long Island Clinical Research Associates
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • Rochester, New York, United States, 14618
      • Gastroenterology Group of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7080
      • University of North Carolina
    • Greenville, North Carolina, United States, 27834
      • Carolina Research
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • TriHealth Digestive Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Mark Osterman
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia VA Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29203-8902
      • Consultants in Gastroenterology - Columbia
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
    • Houston, Texas, United States, 77030
      • Baylor University Medical Center
    • Houston, Texas, United States, 77030
      • UT Health Science Center
    • Humble, Texas, United States, 77338
      • Spring Gastroenterology
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vedolizumab	Drug: Vedolizumab
Other Biologic Agents	Other: Other Biologic Agents; Other biologic agents include: Adalimumab, Certolizumab pegol, Golimumab, and Infliximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and at every 6 months (up to 7 years)
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.	Baseline and at every 6 months (up to 7 years)
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.	Baseline and at every 6 months (up to 7 years)
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.	Baseline and at every 6 months (up to 7 years)
Time to Treatment Discontinuation	Time to discontinuation for Entyvio and the other biologic agents will be measured.	Baseline and at every 6 months (up to 7 years)
Reasons for Treatment Discontinuation	Reasons for discontinuations for Entyvio and the other biologic agents will be measured.	Baseline and at every 6 months (up to 7 years)

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2015
• Primary Completion (Actual): August 3, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: MLN-0002_401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)