VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
Start Date
8/7/2024
Completion Date
2/6/2029
Summary
Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups. Group 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
Vedolizumab
Conditions
Locations
TLC Clinical Research Inc - Los Angeles
Los Angeles, California 90048
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
Concord Repatriation General Hospital
Concord, New South Wales 2139
Australia
Mater Misericordiae Ltd
South Brisbane, Queensland 4101
Australia
Calvary Adelaide Hospital
Adelaide, South Australia 5000
Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000
Australia
The Queen Elizabeth Hospital
Woodville, South Australia 5011
Australia
Northern Hospital Epping
Epping, Victoria 3076
Australia
Austin Health
Heidelberg, Victoria 3084
Australia
The Alfred Hospital
Melbourne, Victoria 3004
Australia
Royal Melbourne Hospital
Melbourne, Victoria
Australia
Harry Perkins institute of Medical Research - Fiona Stanley Hospital
Murdoch, Western Australia 6150
Australia
VITAZ - AZ Nikolaas
Sint-Niklaas, Antwerpen 9100
Belgium
Imelda Ziekenhuis Bonheiden
Bonheiden, Antwerp 2820
Belgium
University Hospital Ghent
Ghent, East Flanders 9000
Belgium
UZ Leuven-University Hospital Gasthuisberg
Leuven, Flemish Brabant 3000
Belgium
AZ Delta - Rumbeke Campus
Roeselare, West Flanders 8800
Belgium
ULB Hopital Erasme
Brussels, 1070
Belgium
University of Calgary
Calgary, Alberta T2N 4Z6
Canada
University of Alberta, Dept of Medicine, Division of Gastroenterology
Edmonton, Alberta T6G 2X8
Canada
Viable Clinical Research - Bridgewater
Bridgewater, Nova Scotia B4V 3N2
Canada
LHSC - University Campus
London, Ontario N6A 5A5
Canada
LHSC - Victoria Hospital
London, Ontario N6A 5W9
Canada
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
Toronto, Ontario
Canada
Vojenska nemocnice Brno
Brno, South Moravian 615 00
Czechia
Fakultni Nemocnice Brno
Brno, South Moravian 625 00
Czechia
Herlev Hospital
Herlev, Capital Region 2730
Denmark
Nordsjaellands Hospital - Hillerod
Hillerød, Capital Region 3400
Denmark
Bispebjerg Hospital
Copenhagen NV, Capital 2400
Denmark
Hvidovre Hospital
Hvidovre, Capital 2650
Denmark
Aarhus Universitetshospital
Aarhus, Central Denmark 8200
Denmark
Randers Regional Hospital
Randers, Central Denmark 83930
Denmark
Sjaellands Universitets hospitall Koge
Køge, Region Sjælland 4600
Denmark
Svendborg Hospital
Svendborg,
Denmark
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes 69495
France
APHM
Marseille, Provence-Alpes-Côte d'Azur Region 13015
France
Groupe Hospitalier Prive Ambroise Pare - Hartmann
Neuilly-sur-Seine,
France
Universitatsklinikum Augsburg
Augsburg, Bavaria 86156
Germany
Universitatsklinkum Frankfurt - Goethe Universitat
Frankfurt am Main, Hesse 60590
Germany
Klinikum Luneburg
Lüneburg, Lower Saxony 21339
Germany
Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus Kiel
Kiel, Schleswig-Holstein 24105
Germany
Universitats Klinikum Freiburg
Freiburg im Breisgau,
Germany
Ospedale Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo, Foggia 71013
Italy
Ospedale Luigi Sacco
Milan, Lombardy 20157
Italy
Ospedale San Raffaele S.r.I.
Milan, Milan 20132
Italy
Policlinico Universitario Agostino Gemelli
Roma, Rome 00168
Italy
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland 6525
Netherlands
Amsterdam UMC - VU Medisch Centrum
Amsterdam, North Holland 1081HV
Netherlands
Erasmus Medisch Centrum (MC)
Rotterdam, South Holland 3015 GD
Netherlands
ETZ - St. Elisabeth Hospital
Tilburg,
Netherlands
Oddzial Gastroenterologiczny SP ZOZ w Lecznej
Łęczna, Gmina Leczna 21-010
Poland
SOLUMED Centrum Medyczne
Poznan, Greater Poland Voivodeship 60-529
Poland
GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j.
Torun, Kuyavian-Pomeranian Voivodeship 87-100
Poland
Melita Medical Sp Zoo
Wroclaw, Lower Silesian Voivodeship 53-611
Poland
Bodyclinic Sp.z.o.o. Sp.K
Warsaw, Masovia 03-712
Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovia 04-501
Poland
Centrum Medyczne Medyk
Rzeszów, Podkarpackie Voivodeship 35-326
Poland
Vita Longa Sp. z o.o.
Katowice, Silesian 40-748
Poland
Sonomed Sp. z o.o. - Centrum Medyczne
Szczecin, West Pomerianian 71-685
Poland
Twoja Przychodnia-Centrum Medyczne Opole
Opole,
Poland
EuroMediCare (EMC) Instytut Medyczny SA
Wroclaw, 54-144
Poland
LisbonCentro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria
Lisbon,
Portugal
Nottingham University Hospitals NHS Trust - QMC
Nottingham, East Midlands NG7 2UH
United Kingdom
London North West University Healthcare NHS Trust - Northwick Park Hospital
Harrow, Middlesex HA1 3UJ
United Kingdom
Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
Barts Health NHS Trust - The Royal London Hospital
London, E1 2AJ
United Kingdom
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
United Kingdom
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
United Kingdom