NCT01346826 - Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD) | Biotech Hunter

Enrollment

145

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

October 31, 2015

Study Completion Date

April 30, 2016

Conditions

Crohn's DiseaseUlcerative Colitis

Interventions

DRUG

Standard 2 hours-infusion

"Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.~After randomization to 2 hours-infusion group, patients get 5 mg/kg infliximab infusion for 2 hours. Total infusion number after randomization is 7."

DRUG

Accelerated 1 hour-infusion

"Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.~After randomization to 1 hour-infusion group, patients get 5 mg/kg infliximab infusion for 1 hour. Total infusion number after randomization is 7."

DRUG

Accelerated 30 minutes-infusion

"Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.~After randomization to 30 minutes-infusion group, patients get 5 mg/kg infliximab infusion for 1 hour. If any infusion reactions do not develop during 2 infusions for 1 hour, patients get further 5 mg/kg infliximab infusion for 30 minutes. The total number of 30 minutes-infusion is 5."

Trial Locations (1)

138736

Asan Medical Center, Seoul