OPTIMAL CARE WITH GUSELKUMAB IN CROHN’S DISEASE

Condition studied

Crohn's disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at W48

Endpoint detail

Morphological remission at W48 assessed using the same tool that was used for the patient’s inclusion: endoscopy, MRI or IUS (major secondary endpoint), SFCR associated with fecal calprotectin < 250 ug/g at W12, W24 and W48, Clinical remission at W12, W24, and W48, Clinical response at W12, Biomarker remission at W12, W24, and W48, Need for guselkumab dose intensification (W12, W24, W48), Change in Short IBD-Q (quality of life index) from baseline (W12, W24, and W48)