Status:
ACTIVE_NOT_RECRUITING
Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
Lead Sponsor:
Alimentiv Inc.
Collaborating Sponsors:
Academic Medical Organization of Southwestern Ontario
Conditions:
Crohn Disease
Remission
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Detailed Description
Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT03261206
Start Date
November 20 2017
End Date
June 1 2026
Last Update
May 20 2025
Active Locations (46)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
2
University of Alberta
Edmonton, Alberta, Canada, L8S 4K1
3
Dr. Jesse Siffledeen Professional Medical Corporation
Edmonton, Alberta, Canada, T6L 6K3
4
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, Canada, V5Z 2K5