Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

Phase 4Active Not RecruitingNCT03261206

Alimentiv Inc.334 enrolled

Overview

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.

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 with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

334

Conditions

Crohn Disease Remission

Interventions

5-ASA WithdrawalOTHER

Withdrawal of 5-ASA therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

CD-related complications at 2 years

CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication

Time frame: 24 months

Secondary Outcomes

CD-related complications at 1 year

CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication

Time frame: 12 months

CD-related or CD-treatment related surgeries at 1 year

Time frame: 12 months

CD-related or CD-treatment related surgeries at 2 years

Time frame: 24 months

CD-related or CD-treatment related hospitalizations at 1 year

Time frame: 12 months

CD-related or CD-treatment related hospitalizations at 2 years

Time frame: 24 months

Other CD-related or CD-treatment related complications at 1 year

Other complication excludes surgeries or hospitalizations

Time frame: 12 months

Other CD-related or CD-treatment related complications at 2 years

Other complication excludes surgeries or hospitalizations

Time frame: 24 months

Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year

Time frame: 12 months

Data from ClinicalTrials.gov

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University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Dr. Jesse Siffledeen Professional Medical Corporation

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(G.I.R.I.) GI Research Institute

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Discovery Clinical Services Ltd.

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London Health Sciences Centre - University Hospital

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...and 36 more locations