A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis

Summary

Participation Requirements

Description

NUMBER OF PATIENTS : 73 patients in each group i.e. a total of 146patients. RECRUITMENT PERIOD : 36 months STUDY DURATION : 12 months PRIMARY END POINT : Treatment failure is defined by: Absence of steroid-free remission at W52 according to the total Mayo Disease Activity Index score OR Absence of m...

NUMBER OF PATIENTS : 73 patients in each group i.e. a total of 146patients. RECRUITMENT PERIOD : 36 months STUDY DURATION : 12 months PRIMARY END POINT : Treatment failure is defined by: Absence of steroid-free remission at W52 according to the total Mayo Disease Activity Index score OR Absence of mucosal healing (Mayo endoscopic subscore 0-1) OR Adverse event leading to treatment interruption OR Colectomy OR Death OR Infliximab withdrawal in the combination therapy group OR Infliximab introduction in the azathioprine group SECONDARY END POINT: - Clinical response and remission at D7, W14 and W52 (according to Lichtiger score and total Mayo Disease Activity Index score) Endoscopic and histological response Mucosal healing (partial endoscopic Mayo subscore 0) Colectomy rate Adverse events rate Fecal calprotectin Health-economic outcome

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