NCT02425852

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare the efficacy and safety of early administration of the combination therapy with infliximab and azathioprine with steroids and azathioprine in patients with acute severe ulcerative colitis treated with intravenous steroids. STUDY TREATMENTS : All patients : Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days. Combination therapy arm: Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day. Azathioprine arm: Steroids tapering for 3 months and Azathioprine 2-2.5 mg/kg/day.

Detailed 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 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

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Azathioprine	Azathioprine alone versus Azathioprine and IFX
DRUG	Infliximab
DRUG	Prednisolone
DRUG	Hydrocortisone

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-06-01
• Completion: 2023-01-01
• First posted: 2015-04-24
• Last updated: 2023-05-31

Locations

16 sites across 1 country: France