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Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
Sponsor: Alimentiv Inc.
Summary
The purpose of this study is to assess whether withdrawal of aminosalicylate (5-ASA) is non-inferior to continuation of 5-ASA therapy in Crohn's disease (CD) subjects in remission.
Official title: Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
334
Start Date
2017-11-20
Completion Date
2026-06
Last Updated
2025-05-20
Healthy Volunteers
No
Conditions
Interventions
5-ASA Withdrawal
Withdrawal of 5-ASA therapy
Locations (46)
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Dr. Jesse Siffledeen Professional Medical Corporation
Edmonton, Alberta, Canada
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, Canada
Discovery Clinical Services Ltd.
Victoria, British Columbia, Canada
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Scott Shulman Medical Professional Corporation
North Bay, Ontario, Canada
Taunton Surgical Center
Oshawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Dr. O. Tarabain Medicine Professional Corporation
Windsor, Ontario, Canada
McGill University Healthcare
Montreal, Quebec, Canada
IRCCS Policlinico San Donato
San Donato Milanese, Milan Italy, Italy
Ospedale San Raffaele S.r.I.
Milan, Milan, Italy
UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali
Roma, Rome, Italy
IRCCS De Bellis
Castellana Grotte, Via Turi, Italy
Luigi Vanvitelli of Campania
Catania, Italy
Intituto Clinico Humanitas
Milan, Italy
Azienda Ospedale-Universita Padova
Padova, Italy
Campus Bio-Medico University of Rome
Roma, Italy
BYK - Kyiv
Kyiv, Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, Ukraine
Odesa Regional Clinical Hospital
Odesa, Ukraine
Ternopil University Hospital
Ternopil, Ukraine
Warrington and Halton Hospitals NHS Foundation Trust
Warrington, Cheshire, United Kingdom
Darlington Memorial Hospital
Darlington, Durham, United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, United Kingdom
Royal Blackburn Hospital
Blackburn, Lancashire, United Kingdom
St. Marks Hospital
Harrow, Middlesex, United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital
Sutton in Ashfield, Nottinghamshire, United Kingdom
Barnsley Hospital NHS Trust
Barnsley, Yorkshire, United Kingdom
Bedford Hospital NHS Trust
Bedford, United Kingdom
Southmead Hospital, North Bristol NHS Trust
Bristol, United Kingdom
Northern Care Alliance NHS Group - Fairfield General Hospital
Bury, United Kingdom
West Suffolk Hospital
Bury St Edmunds, United Kingdom
ESNEFT Colchester Gen Hospital
Colchester, United Kingdom
Dudley Group NHS Foundation Trust
Dudley, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
Leicester, United Kingdom
Royal Free Hospital
London, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust
London, United Kingdom
Luton and Dustable Hospital Foundation Trust
Luton, United Kingdom
Nottingham University Hospitals NHS Trust and University of Nottingham
Nottingham, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
Salford Ryal NHS Foundation Trust
Salford, United Kingdom
Airedale NHS Foundation Trust
Steeton, United Kingdom