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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02674308
Other study ID # MLN-0002_401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 24, 2015
Est. completion date August 3, 2021

Study information

Verified date August 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 5302
Est. completion date August 3, 2021
Est. primary completion date August 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Vedolizumab

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Croatia,  Denmark,  Estonia,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Netherlands,  Norway,  Portugal,  Slovenia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)