Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
STATIC
1 other identifier
interventional
334
4 countries
46
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2017
Longer than P75 for phase_4
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedStudy Start
First participant enrolled
November 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
May 20, 2025
May 1, 2025
8.5 years
August 22, 2017
May 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
CD-related complications at 2 years
CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
24 months
Secondary Outcomes (23)
CD-related complications at 1 year
12 months
CD-related or CD-treatment related surgeries at 1 year
12 months
CD-related or CD-treatment related surgeries at 2 years
24 months
CD-related or CD-treatment related hospitalizations at 1 year
12 months
CD-related or CD-treatment related hospitalizations at 2 years
24 months
- +18 more secondary outcomes
Study Arms (2)
5-ASA Continuation
NO INTERVENTIONHalf of the subjects will continue on aminosalicylate therapy using the same dose and brand for the duration of the study
5-ASA Withdrawal
EXPERIMENTALHalf of the subjects will discontinue their aminosalicylate therapy
Interventions
Eligibility Criteria
You may qualify if:
- Documented diagnosis of CD at least 3 months prior to enrollment
- 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
You may not qualify if:
- A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta
Edmonton, Alberta, L8S 4K1, Canada
Dr. Jesse Siffledeen Professional Medical Corporation
Edmonton, Alberta, T6L 6K3, Canada
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V5Z 2K5, Canada
Discovery Clinical Services Ltd.
Victoria, British Columbia, V8T 5G4, Canada
University of Manitoba - Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
Scott Shulman Medical Professional Corporation
North Bay, Ontario, P1B2H3, Canada
Taunton Surgical Center
Oshawa, Ontario, L1H 7K4, Canada
Mount Sinai Hospital
Toronto, Ontario, M5T 3L9, Canada
Dr. O. Tarabain Medicine Professional Corporation
Windsor, Ontario, N8W 1E6, Canada
McGill University Healthcare
Montreal, Quebec, N6A 5B6, Canada
IRCCS Policlinico San Donato
San Donato Milanese, Milan Italy, 20097, Italy
Ospedale San Raffaele S.r.I.
Milan, Milan, 20132, Italy
UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali
Roma, Rome, 00135, Italy
IRCCS De Bellis
Castellana Grotte, Via Turi, 27-70013, Italy
Luigi Vanvitelli of Campania
Catania, 95123, Italy
Intituto Clinico Humanitas
Milan, 20089, Italy
Azienda Ospedale-Universita Padova
Padua, 35128, Italy
Campus Bio-Medico University of Rome
Roma, 00128, Italy
BYK - Kyiv
Kyiv, 01030, Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, 79059, Ukraine
Odesa Regional Clinical Hospital
Odesa, 65025, Ukraine
Ternopil University Hospital
Ternopil, 46002, Ukraine
Warrington and Halton Hospitals NHS Foundation Trust
Warrington, Cheshire, WA5 1QG, United Kingdom
Darlington Memorial Hospital
Darlington, Durham, DL3 6HX, United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, SS16 5NL, United Kingdom
Royal Blackburn Hospital
Blackburn, Lancashire, BB2 3HH, United Kingdom
St. Marks Hospital
Harrow, Middlesex, HA1 3UJ, United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Barnsley Hospital NHS Trust
Barnsley, Yorkshire, S75 2EP, United Kingdom
Bedford Hospital NHS Trust
Bedford, MK42 9DJ, United Kingdom
Southmead Hospital, North Bristol NHS Trust
Bristol, BS10 5NB, United Kingdom
Northern Care Alliance NHS Group - Fairfield General Hospital
Bury, BL9 7TD, United Kingdom
West Suffolk Hospital
Bury St Edmunds, IP33 2QZ, United Kingdom
ESNEFT Colchester Gen Hospital
Colchester, CO4 3JA, United Kingdom
Dudley Group NHS Foundation Trust
Dudley, DY1 2HQ, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, EX2 5DW, United Kingdom
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Royal Free Hospital
London, Nw3 2QG, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust
London, SE1 7EH, United Kingdom
Luton and Dustable Hospital Foundation Trust
Luton, LU4 0DZ, United Kingdom
Nottingham University Hospitals NHS Trust and University of Nottingham
Nottingham, NG7 2UH, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN, United Kingdom
Salford Ryal NHS Foundation Trust
Salford, M6 8HD, United Kingdom
Airedale NHS Foundation Trust
Steeton, BD20 6TD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vipul Jairath, MD
Western University; London Health Sciences Centre
- PRINCIPAL INVESTIGATOR
Gordon Moran, MD
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2017
First Posted
August 24, 2017
Study Start
November 20, 2017
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 20, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share