Crohn's DiseasePhase 4NCT01346826
Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)
A Phase 4 study testing Standard 2 hours-infusion, Accelerated 1 hour-infusion and Accelerated 30 minutes-infusion in people with Crohn's Disease and Ulcerative Colitis, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Standard 2 hours-infusion, Accelerated 1 hour-infusion and Accelerated 30 minutes-infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Sever cardiopulmonary diseases
- Allergic diseases
- Bronchial asthma
- Allergic rhinitis
- Atopic dermatitis
- Other allergic diseases determined not suitable for study participation by investigators
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- Severe liver disease
- Severe renal disease
- Body weight over 100 kg
- Other medical or surgical disease determined not suitable for study participation by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial
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.
Read the 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- Standard 2 hours-infusion, Accelerated 1 hour-infusion, Accelerated 30 minutes-infusion
- Keywords
- Crohn's disease, Ulcerative colitis, Infliximab, Infusion reaction
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard 2 hours-infusionDrug
Also called Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
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.
Accelerated 1 hour-infusionDrug
Also called Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
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.
Accelerated 30 minutes-infusionDrug
Also called Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 hours-infusion group | Active comparator | Number of patients: 57 (Standard 2 hours-infusion group) Receives: Drug: Standard 2 hours-infusion |
| 1 hour-infusion group | Experimental | Number of patients: 59 (1 hour-infusion group) Receives: Drug: Accelerated 1 hour-infusion |
| 30 minutes-infusion group | Experimental | Number of patients: 59 (30 minutes-infusion group) Receives: Drug: Accelerated 30 minutes-infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total numbers of infusion reactions related with infliximab infusion
Total numbers of infusion reactions (including acute and delayed reactions) related with infliximab infusion
Measured: Within14 days after infliximab infusion
Secondary outcomes (1)
Numbers of severe infusion reactions related with 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
Measured: Within14 days after infliximab infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk-Kyun Yang, Asan Medical Center
- Investigators
- Suk-Kyun Yang, MD, PhD, Principal investigator, Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346826
- Sponsor's protocol ID
- 2011-0181
- Status last verified
- Jul 2016
- First submitted
- 2 May 2011
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Clare DF, Alexander FC, Mike S, Dan G, Allan F, Lisa W, Peter HJ. Accelerated infliximab infusions are safe and well tolerated in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2009 Jan;21(1):71-5. doi: 10.1097/MEG.0b013e3283081afe.
PubMed 19060632Van Assche G, Vermeire S, Noman M, Amant C, Weyts E, Vleminckx A, Vermeyen MJ, Rutgeerts P. Infliximab administered with shortened infusion times in a specialized IBD infusion unit: a prospective cohort study. J Crohns Colitis. 2010 Sep;4(3):329-33. doi: 10.1016/j.crohns.2009.12.012. Epub 2010 Jan 18.
PubMed 21122522Bhat S, Sharma D, Doherty P, Tham TC, Caddy GR. Are accelerated infliximab infusions safe in patients with inflammatory bowel disease? Inflamm Bowel Dis. 2010 Nov;16(11):1922-5. doi: 10.1002/ibd.21279.
PubMed 20848465Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.
PubMed 21407184
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT01346826
- Acronym / sponsor ID
- 2011-0181
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Crohn's disease, Ulcerative colitis, Infliximab, Infusion reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 hours-infusion group | Active comparator | Drug: Standard 2 hours-infusionNumber of patients: 57 (Standard 2 hours-infusion group) |
| 1 hour-infusion group | Experimental | Drug: Accelerated 1 hour-infusionNumber of patients: 59 (1 hour-infusion group) |
| 30 minutes-infusion group | Experimental | Drug: Accelerated 30 minutes-infusionNumber of patients: 59 (30 minutes-infusion group) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Sever cardiopulmonary diseases
- Allergic diseases
- Severe liver disease
- Severe renal disease
- Body weight over 100 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard 2 hours-infusionAlso: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)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 | 2 hours-infusion group |
| Accelerated 1 hour-infusionAlso: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)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 | 1 hour-infusion group |
| Accelerated 30 minutes-infusionAlso: Infliximab (Remicade, Centocor, Malvern, Philadelphia, PA)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. | Drug | 30 minutes-infusion group |
Primary outcome
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
1 secondary outcome
Numbers of severe infusion reactions related with infliximab infusion
Time frame: Within14 days after infliximab infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Background: PubMed 19060632Clare DF, Alexander FC, Mike S, Dan G, Allan F, Lisa W, Peter HJ. Accelerated infliximab infusions are safe and well tolerated in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2009 Jan;21(1):71-5. doi: 10.1097/MEG.0b013e3283081afe.
- Background: PubMed 21122522Van Assche G, Vermeire S, Noman M, Amant C, Weyts E, Vleminckx A, Vermeyen MJ, Rutgeerts P. Infliximab administered with shortened infusion times in a specialized IBD infusion unit: a prospective cohort study. J Crohns Colitis. 2010 Sep;4(3):329-33. doi: 10.1016/j.crohns.2009.12.012. Epub 2010 Jan 18.
- Background: PubMed 20848465Bhat S, Sharma D, Doherty P, Tham TC, Caddy GR. Are accelerated infliximab infusions safe in patients with inflammatory bowel disease? Inflamm Bowel Dis. 2010 Nov;16(11):1922-5. doi: 10.1002/ibd.21279.
- Background: PubMed 21407184Breynaert C, Ferrante M, Fidder H, Van Steen K, Noman M, Ballet V, Vermeire S, Rutgeerts P, Van Assche G. Tolerability of shortened infliximab infusion times in patients with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011 Apr;106(4):778-85. doi: 10.1038/ajg.2011.61. Epub 2011 Mar 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suk-Kyun Yang, MD, PhD principal investigator
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard 2 hours-infusion, Accelerated 1 hour-infusion and Accelerated 30 minutes-infusion in people with Crohn's Disease and Ulcerative Colitis, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total numbers of infusion reactions related with infliximab infusion (time frame: Within14 days after infliximab infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346826, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.