Stopping Aminosalicylate Therapy in Inactive Crohn's Disease
- Conditions
- Crohn DiseaseRemission
- Registration Number
- NCT03261206
- Lead Sponsor
- Alimentiv Inc.
- 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 334
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method CD-related complications at 2 years 24 months CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
- Secondary Outcome Measures
Name Time Method CD-related or CD-treatment related surgeries at 1 year 12 months CD-related or CD-treatment related hospitalizations at 1 year 12 months Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year 12 months Time to first CD-related complication up to 24 months CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
CD-related or CD-treatment related hospitalizations at 2 years 24 months Other CD-related or CD-treatment related complications at 1 year 12 months Other complication excludes surgeries or hospitalizations
Other CD-related or CD-treatment related complications at 2 years 24 months Other complication excludes surgeries or hospitalizations
Change in self-assessed quality of life at 2 years Base line and 24 months Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in CD-related and total healthcare costs at 2 years 12 months prior to enrollment and 24 months after enrollment Estimated costs before and after enrollment
CD-related complications at 1 year 12 months CD-related complications include either a CD-related or CD treatment-related surgery, hospitalization, or other complication
Change in disease activity at 24 months 24 months Disease activity assessed by HBI score
CD-related or CD-treatment related surgeries at 2 years 24 months Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years 24 months Change in self-assessed quality of life at 1 year Base line and 12 months Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in C-reactive protein concentration at 1 year Base line and 12 months Change in CD-related drug treatment costs at 2 years 12 months prior to enrollment and 24 months after enrollment Estimated drug treatment costs before and after enrollment
Change in disease activity at 6 months 6 months Disease activity assessed by HBI score
Change in disease activity at 12 months 12 months Disease activity assessed by HBI score
Change in self-assessed quality of life at 6 months Base line and 6 months Quality of life assessed with the Crohn's and Ulcerative Colitis Questionnaire 32-item
Change in C-reactive protein concentration at 6 months Base line and 6 months Change in C-reactive protein concentration at 2 years Base line and 24 months Change in fecal calprotectin concentration at 2 years Base line and 24 months Change in fecal calprotectin concentration at 1 year Base line and 12 months
Trial Locations
- Locations (46)
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
Scroll for more (36 remaining)University of Calgary🇨🇦Calgary, Alberta, Canada