Crohn's Disease, Ulcerative Colitis
Conditions
Keywords
Crohn's disease, Ulcerative colitis, Infliximab, Infusion reaction
Brief summary
This study aims to test the hypothesis that the accelerated infusion of infliximab is not inferior to the conventional 2 hour infusion with respect to the frequency of infusion reaction.
Detailed description
The standard protocol of infliximab administration is the infusion for 2 hours. However, due to the discomfort of patients and limitation of medical resources, the accelerated infusion is more desirable if accelerated infusion does not increase the frequency of infusion reaction. Recent observational studies showed that the accelerated infusion of infliximab for 1 hour or 30 minutes did not increase the frequency of infusion reaction if patients had not shown infusion reactions during previous 4 infusions for 2 hours. However, there are no randomized trials comparing the safety of accelerated infusion protocol and standard infusion protocol yet.
Interventions
DRUGStandard 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.
DRUGAccelerated 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.
DRUGAccelerated 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.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients receiving infliximab for Crohn's disease or ulcerative colitis * Ethnicity: Korean * Patients who did not show any infusion reactions during 4 times of infliximab (5mg/kg) infusions for 2 hours * Informed consents
Exclusion criteria
* Sever cardiopulmonary diseases * Allergic diseases * Bronchial asthma * Allergic rhinitis * Atopic dermatitis * Other allergic diseases determined not suitable for study participation by investigators * Severe liver disease * Severe renal disease * Body weight over 100 kg * Other medical or surgical disease determined not suitable for study participation by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total numbers of infusion reactions related with infliximab infusion | Within14 days after infliximab infusion | Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of severe infusion reactions related with infliximab infusion | Within14 days after infliximab infusion | Numbers of severe infusion reactions (Systolic blood pressure \< 80 mmHg with severe symptoms and signs necessiating stopping of infliximab infusion) related with infliximab infusion |
Countries
South Korea
Outcome results
None listed