Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)
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ClinicalTrials.gov Identifier: NCT01346826 |
Recruitment Status
:
Completed
First Posted
: May 3, 2011
Last Update Posted
: July 12, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease Ulcerative Colitis | Drug: Standard 2 hours-infusion Drug: Accelerated 1 hour-infusion Drug: Accelerated 30 minutes-infusion | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 145 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 2 hours-infusion group
Number of patients: 57 (Standard 2 hours-infusion group)
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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. Other Name: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
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Experimental: 1 hour-infusion group
Number of patients: 59 (1 hour-infusion group)
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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. Other Name: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
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Experimental: 30 minutes-infusion group
Number of patients: 59 (30 minutes-infusion group)
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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. Other Name: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
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- Total numbers of infusion reactions related with infliximab infusion [ Time Frame: Within14 days after infliximab infusion ]Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion
- Numbers of severe infusion reactions related with infliximab infusion [ Time Frame: 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

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Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346826
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of, 138736 |
Principal Investigator: | Suk-Kyun Yang, MD, PhD | Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine |
Publications:
Responsible Party: | Suk-Kyun Yang, Professor, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01346826 History of Changes |
Other Study ID Numbers: |
2011-0181 |
First Posted: | May 3, 2011 Key Record Dates |
Last Update Posted: | July 12, 2016 |
Last Verified: | July 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Suk-Kyun Yang, Asan Medical Center:
Crohn's disease Ulcerative colitis Infliximab Infusion reaction |
Additional relevant MeSH terms:
Crohn Disease Colitis Ulcer Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Pathologic Processes Infliximab Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents |