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Crohn's patients in remission may ditch daily pills, study hints

NCT ID NCT03261206

Disease control Sponsor: Alimentiv Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether people with Crohn's disease who are in remission can safely stop taking aminosalicylate (5-ASA) medication without their condition getting worse. About 334 participants will either continue or stop their 5-ASA therapy and be followed for 2 years to see if they develop complications like surgery or hospitalization. The goal is to find out if stopping is as safe as continuing for those whose disease is quiet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

334 people

The number who actually took part.

Started

Nov 2017

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Remission

Contacts and locations

Locations

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V5Z 2K5, Canada

  • Airedale NHS Foundation Trust

    Steeton, BD20 6TD, United Kingdom

  • Azienda Ospedale-Universita Padova

    Padova, 35128, Italy

  • BYK - Kyiv

    Kyiv, 01030, Ukraine

  • Barnsley Hospital NHS Trust

    Barnsley, Yorkshire, S75 2EP, United Kingdom

  • Basildon and Thurrock University Hospitals NHS Foundation Trust

    Basildon, Essex, SS16 5NL, United Kingdom

  • Bedford Hospital NHS Trust

    Bedford, MK42 9DJ, United Kingdom

  • Campus Bio-Medico University of Rome

    Roma, 00128, Italy

  • Danylo Halytsky Lviv National Medical University

    Lviv, 79059, Ukraine

  • Darlington Memorial Hospital

    Darlington, Durham, DL3 6HX, United Kingdom

  • Discovery Clinical Services Ltd.

    Victoria, British Columbia, V8T 5G4, Canada

  • Dr. Jesse Siffledeen Professional Medical Corporation

    Edmonton, Alberta, T6L 6K3, Canada

  • Dr. O. Tarabain Medicine Professional Corporation

    Windsor, Ontario, N8W 1E6, Canada

  • Dudley Group NHS Foundation Trust

    Dudley, DY1 2HQ, United Kingdom

  • ESNEFT Colchester Gen Hospital

    Colchester, CO4 3JA, United Kingdom

  • Guy's and St. Thomas' Hospitals NHS Trust

    London, SE1 7EH, United Kingdom

  • IRCCS De Bellis

    Castellana Grotte, Via Turi, 27-70013, Italy

  • IRCCS Policlinico San Donato

    San Donato Milanese, Milan Italy, 20097, Italy

  • Intituto Clinico Humanitas

    Milan, 20089, Italy

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5, Canada

  • Luigi Vanvitelli of Campania

    Catania, 95123, Italy

  • Luton and Dustable Hospital Foundation Trust

    Luton, LU4 0DZ, United Kingdom

  • McGill University Healthcare

    Montreal, Quebec, N6A 5B6, Canada

  • Mount Sinai Hospital

    Toronto, Ontario, M5T 3L9, Canada

  • Northern Care Alliance NHS Group - Fairfield General Hospital

    Bury, BL9 7TD, United Kingdom

  • Nottingham University Hospitals NHS Trust and University of Nottingham

    Nottingham, NG7 2UH, United Kingdom

  • Odesa Regional Clinical Hospital

    Odesa, 65025, Ukraine

  • Ospedale San Raffaele S.r.I.

    Milan, Milan, 20132, Italy

  • Royal Berkshire NHS Foundation Trust

    Reading, RG1 5AN, United Kingdom

  • Royal Blackburn Hospital

    Blackburn, Lancashire, BB2 3HH, United Kingdom

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DW, United Kingdom

  • Royal Free Hospital

    London, Nw3 2QG, United Kingdom

  • Salford Ryal NHS Foundation Trust

    Salford, M6 8HD, United Kingdom

  • Scott Shulman Medical Professional Corporation

    North Bay, Ontario, P1B2H3, Canada

  • Sherwood Forest Hospitals NHS Foundation Trust - Kings Mill Hospital

    Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom

  • Southmead Hospital, North Bristol NHS Trust

    Bristol, BS10 5NB, United Kingdom

  • St. Marks Hospital

    Harrow, Middlesex, HA1 3UJ, United Kingdom

  • Taunton Surgical Center

    Oshawa, Ontario, L1H 7K4, Canada

  • Ternopil University Hospital

    Ternopil, 46002, Ukraine

  • UOC Gastroenterologic UOS Malattie Infiammatorie Intestinali, Ospedali

    Roma, Rome, 00135, Italy

  • University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • University of Alberta

    Edmonton, Alberta, L8S 4K1, Canada

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • University of Manitoba - Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9, Canada

  • Warrington and Halton Hospitals NHS Foundation Trust

    Warrington, Cheshire, WA5 1QG, United Kingdom

  • West Suffolk Hospital

    Bury St Edmunds, IP33 2QZ, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.