Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT01346826
• Date of registration: 02/05/2011
• Prospective Registration: No
• Primary sponsor: Asan Medical Center
• Public title: Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)
• Scientific title: Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial
• Date of first enrolment: May 2011
• Target sample size: 145
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01346826
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: Suk-Kyun Yang, MD, PhD
• Affiliation: Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine

Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Ulcerative Colitis

Intervention(s)

Drug: Accelerated 30 minutes-infusion

Drug: Accelerated 1 hour-infusion

Drug: Standard 2 hours-infusion

Primary Outcome(s)

Total numbers of infusion reactions related with infliximab infusion [Time Frame: Within14 days after infliximab infusion]

Secondary Outcome(s)

Numbers of severe infusion reactions related with infliximab infusion [Time Frame: Within14 days after infliximab infusion]

Secondary ID(s)

2011-0181

Source(s) of Monetary Support

Please refer to primary and secondary sponsors