Crohn's disease
Conditions
Brief summary
Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at W48
Detailed description
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)
Interventions
DRUGGuselkumab
Sponsors
i-GETAID
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steroid free clinical remission (SFCR) associated with fecal calprotectin < 250 ug/g at W48 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Outcome results
None listed