In this parallel-group, open-label, randomized, non-inferiority trial, 1580 subjects with CD in remission will be allocated in a 1:1 ratio to either continue their aminosalicylate therapy or withdraw their aminosalicylate. The trial will be conducted in centres throughout North America, Europe and Australia in both secondary and primary care. All cases deemed by the local investigator to have met any component of the primary endpoint will be adjudicated by an independent, blinded, adjudication panel.
The primary objective of this study is to determine whether withdrawal of aminosalicylates is non-inferior to the continuation of aminosalicylate therapy in subjects with Crohn’s Disease in remission with regard to a primary endpoint of any Crohn’s Disease -related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization, or other complication) within 24 months after treatment allocation.
The secondary objectives of the study are to compare the effects of the withdrawal of aminosalicylates to the continuation of aminosalicylate therapy with regards to:
- Any CD-related complication within the first 12 months after enrollment
- Each individual component of the primary composite endpoint (CD-related or CD treatment-related surgeries, hospitalizations, and other complication) within 12 and 24 months after enrollment
- The use of systemic corticosteroids for treatment of CD flares within 12 and 24 months after enrollment
- Time to first CD-related complication
- Change in disease activity from baseline to 6, 12, and 24 months after enrollment, as assessed by change in the Harvey-Bradshaw index
- Change in quality of life from baseline
- Change in C-reactive protein concentration from baseline
- Change in fecal calprotectin level from baseline
- Estimated CD-related drug treatment costs over the 24 months after enrollment compared to the 12 months prior to enrollment
- Estimated CD-related and total healthcare costs over the 24 months after enrollment compared to the 12 months prior to enrollment