Thiers

Crohn's disease is a chronic inflammatory bowel condition that can severely impact patients' quality of life and often leads to intestinal damage requiring surgery. This trial investigates whether combining a standard close monitoring strategy using clinical symptoms and fecal calprotectin with additional MRI scans to assess transmural healing improves long-term remission in patients treated with biotherapy. The study explores if this combined "CALM + MRI" approach is better than the traditional "CALM" strategy alone for maintaining symptom-free periods without corticosteroids. Participants are randomly assigned to one of two groups: the reference group follows the CALM strategy with regular visits and treatment adjustments based on clinical symptoms and fecal calprotectin levels at multiple time points up to week 152 (about 3 years). The investigational group receives the same follow-up plus extra MRI scans at weeks 24 and 52, with treatment intensifications if MRI indicates ongoing disease activity. All participants undergo MRI at the beginning, week 76, and week 152. Treatment changes follow established French guidelines. Monthly symptom diaries track abdominal pain and stool frequency. Throughout the 152-week study, patients have evaluations including clinical assessments, fecal calprotectin tests, and MRIs to monitor disease activity and healing. The main outcome measured is the proportion of months patients spend in clinical remission between weeks 24 and 76. Secondary outcomes include response rates and imaging-based healing measures reviewed centrally to minimize bias. Missing data are handled by considering those months as non-remission periods. This comprehensive follow-up aims to determine if adding MRI to close clinical and biological monitoring provides better disease control.