A Prospective Multicenter Randomized Controlled, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn’s Disease ( Direct-CD)

Crohn's disease

The proportion of patients in corticosteroid-free clinical remission (as defined by CDAI<150) AND endoscopic response (a drop of at least 50% in SES-CD compared to baseline) at week 26

The proportion of patients in endoscopic remission at week 26 (defined as the absence of ulcerations larger then 5mm)  Proportion of patients with endoscopic remission at week 26 (as measured by SES-CD≤2)  Proportion of patients with endoscopic response at week 26 (as measured by at least 50% reduction in the SES-CD as compared to baseline)  Proportion of patients in corticosteroid-free clinical remission at week 26 (defined as a CDAI<150)

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Netherlands