Crohn Disease, Remission
Conditions
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.
Interventions
OTHER5-ASA Withdrawal
Withdrawal of 5-ASA therapy
Sponsors
Alimentiv Inc.
Academic Medical Organization of Southwestern Ontario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| 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 |
| Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 1 year | 12 months | — |
| Proportion of patients who require the use of systemic corticosteroids for treatment of CD flares at 2 years | 24 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 |
| 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 disease activity at 24 months | 24 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 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 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 C-reactive protein concentration at 6 months | Base line and 6 months | — |
| Change in C-reactive protein concentration at 1 year | Base line and 12 months | — |
| Change in C-reactive protein concentration at 2 years | Base line and 24 months | — |
| Change in fecal calprotectin concentration at 1 year | Base line and 12 months | — |
| Change in fecal calprotectin concentration at 2 years | Base line and 24 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 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 |
Countries
Canada, Italy, Ukraine, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORVipul Jairath, MD
Western University; London Health Sciences Centre
PRINCIPAL_INVESTIGATORGordon Moran, MD
University of Nottingham
Outcome results
None listed