Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
NCT ID: NCT03261206
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
334 participants
INTERVENTIONAL
2017-11-20
2026-06-30
Brief Summary
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Detailed Description
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In this open-label, randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24 month period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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5-ASA Continuation
Half of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
No interventions assigned to this group
5-ASA Withdrawal
Half of the subjects will discontinue their aminosalicylate therapy
5-ASA Withdrawal
Withdrawal of 5-ASA therapy
Interventions
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5-ASA Withdrawal
Withdrawal of 5-ASA therapy
Eligibility Criteria
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Inclusion Criteria
* Taking any brand or dosage of an oral aminosalicylate for at least 6 months
* Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
* CD currently in clinical remission
* Able to participate fully in all aspects of the clinical trial
* Written informed consent obtained and documented
Exclusion Criteria
* A diagnosis of short-bowel syndrome
* Active perianal disease
* Active fistulizing disease
* A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
* Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
* Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment
* Unwillingness to stop taking aminosalicylates for the duration of the trial
* Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment
* Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study
* History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures
* Currently participating in another interventional trial, or previous participation within the last 3 months
18 Years
ALL
No
Sponsors
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Academic Medical Organization of Southwestern Ontario
OTHER
Alimentiv Inc.
OTHER
Responsible Party
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Principal Investigators
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Vipul Jairath, MD
Role: PRINCIPAL_INVESTIGATOR
Western University; London Health Sciences Centre
Gordon Moran, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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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
Padua, , 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
Countries
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Other Identifiers
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RP1610
Identifier Type: -
Identifier Source: org_study_id
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