Evaluating the Benefit of Adding MRI to Fecal Calprotectin Monitoring in Adults with Crohns Disease on Biologic Therapy

What this Trial Is About

Crohns disease CD is a chronic inflammatory bowel disease that can severely impact patients quality of life by causing intestinal damage such as stenosis and fistulas, often leading to surgery. The goal of treatment has evolved from just clinical remission to achieving both clinical remission and healing of the intestinal lining, which reduces disease progression risks. The CALM strategy uses close monitoring of symptoms and biological markers like fecal calprotectin to guide treatment intensification and improve healing outcomes. Researchers are investigating whether adding MRI-based assessment of transmural healing to this approach can further reduce disease progression in patients receiving biotherapy. This randomized, open-label study compares two treatment strategies for adults with active Crohns disease starting biotherapy. One group follows the CALM strategy with regular clinical and biological monitoring, while the other group adds scheduled MRI evaluations to assess transmural healing. MRIs are performed at baseline, weeks 24, 52, 76, and 152 in the MRI group, with treatment intensification based on residual activity seen on imaging. Both groups receive biotherapy guided by French consensus guidelines, and patients are followed for approximately three years. Participants will be regularly monitored through clinical evaluations, fecal calprotectin tests, and MRIs as scheduled. They will keep a symptom diary recording abdominal pain and stool frequency monthly. Researchers will measure the proportion of time spent in clinical remission without corticosteroids between weeks 24 and 76 as the primary outcome. Safety and other secondary outcomes will be assessed centrally. The study will analyze data on an intention-to-treat basis and includes ongoing follow-up over nearly three years.

STUDY OF THE ADDED VALUE OF A TRANSMURAL EVALUATION IN PATIENTS WITH CROHN'S DISEASE UNDER BIOTHERAPY WITH CLOSE FECAL CALPROTECTIN FOLLOW-UP