Inflammatory Bowel DiseasesPhase 4NCT05340764
Safety of Reduced Infliximab Infusion Time
A Phase 4 study testing Infliximab in people with Inflammatory Bowel Diseases, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Remicade is a common medicine used for the treatment of inflammatory bowel disease. This medication is given as an intravenous infusion over 2 hours. Studies have suggested it is safe to give the infusion at a faster rate. The investigators would like to see if the infusion can be given over 1 hour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 4 May 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age
- Must have a diagnosis of IBD
- Must be receiving Infliximab or biosimilar drug infusions for IBD at one of the study infusion centers - Center for Advanced Medicine, Barnes-Jewish West County, Barnes-Jewish South County infusion centers, or receiving infusion through BJC Home Care Services/ Barnes Home Health Company.
- Must tolerate the three induction doses or be tolerating current maintenance dosing without an infusion reaction to qualify for randomization.
Who cannot join
- Those receiving Infliximab for an indication other than IBD (the investigators will include patients receiving infliximab or biosimilar drug for both IBD and an additional autoimmune disease)
- Patients with history of a moderate or severe infusion reactions to infliximab or to an infliximab biosimilar as defined in section 7
- Patients with known antidrug antibodies to infliximab
- Patients who are restarting infliximab (patients who have received infliximab within the past year but have now had an interval greater than 13 weeks between prior dose) must tolerate the three induction doses to qualify for randomization
- Patients receiving an additional infusion concomitant with infliximab (e.g. IV iron)
- Patients who decline to participate in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Safety, Efficacy, and Cost-effectiveness of a Reduced Infliximab Infusion Time Protocol
Remicade is a common medicine used for the treatment of inflammatory bowel disease. This medication is given as an intravenous infusion over 2 hours. Studies have suggested it is safe to give the infusion at a faster rate. The investigators would like to see if the infusion can be given over 1 hour. The investigators expect that increasing the rate of infusion WILL NOT lead to an increase in infusion reactions and will be just as safe and effective as the standard 2 hours dose.
Read the detailed description
1.1 Infliximab use in IBD
Inflammatory bowel disease (IBD) affects 349 per 100,000 adults in the United States and is associated with significant morbidity and mortality. Infliximab is an effective and commonly used medication to treat patients with IBD, but a main safety concern is an antibody-induced infusion reaction. The incidence of infusion reactions is ~6.5%, with mild, moderate, or severe reactions occurring in 3.1%, 1.2%, and 1% of infusions, respectively. Because of the concern for infusions reactions, infliximab is FDA approved to be infused over 2 hours or more. The typical interval for infusions is every eight weeks but is at times reduced to every 4 weeks in patients with IBD. This infusion time represents a significant inconvenience to patients who receive regular maintenance infusions.
1.2 Accelerated Infliximab Infusions
Multiple studies outside of the United States have demonstrated that a shortened infusion time to one hour, and even thirty minutes is safe and tolerable with similar rates of infusion reactions compared to an infusion time of two hours. However, these studies have differed in dosing, interval, pre-medication allowed in the study, and they are not randomized controlled studies. It has also been shown that reducing infusion times leads to cost savings and increased patient satisfaction. A recent study conducted in the United States at the University of California in San Francisco, confirmed that a shortened infusion time of one hour is safe and tolerated.
1.3 Rationale
The hypothesis is that a shortened infusion time to one hour will be safe and tolerated, with equal infusion reaction rates compared to two-hour infusion
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Infliximab
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Infliximab is an effective and commonly used medication to treat patients with IBD
| Study group | Role | What they receive |
|---|---|---|
| 2-hour infusion of infliximab | Active comparator | 2 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group. Receives: Drug: Infliximab |
| 1-hour infusion of infliximab | Experimental | 1 hour infusion of infliximab
Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group. Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit
Acute infusion reaction is defined as any reaction occurring during or within 1 hour after completion of the infusion. It will be separated into mild reactions and moderate/severe reactions as outlined below.
Mild/Localized Reaction Pruritus Flushing (facial erythema) Rash/Urticaria Rigors Swelling Moderate/Severe Reaction Fever (temperature > 38.3 degree Celsius) Heart Rate greater than 120 Dyspnea/Shortness of breath Decrease in consciousness Hypotension defined as decrease in baseline SBP by >20 mmHg or SBP <85 Bronchospasm or laryngospasm Anaphylactic shock of one hour, to the standard two-hour infusion.
Measured: Median of 12 months in the control and a median of 14 months in the study group.
Secondary outcomes (4)
Cost Saving Analysis
Direct costs of the 2 hour infusion per-infusion per-patient in dollar amount will be compared to direct costs of the 1 hour infusion per-infusion per-patient in dollar amount in our institution and the difference will be reported.
Nursing Cost and Chair Occupancy Cost obtained from BJH Human Resources Department.
Measured: Median of 12 months in the control and a median of 14 months in the study group.
Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Median Number of Infusions
Assess effect of concomitant immunomodulators and pre-medications on rate of infusion reactions - Median number of infusions
Measured: Median of 12 months in the control and a median of 14 months in the study group.
Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
Number of Infusions where Concomitant Immunomodulators and Pre-medications were used in the study
Measured: Median of 12 months in the control and a median of 14 months in the study group.
Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Duration of Follow up (in Months)
Assess effect of concomitant immunomodulators and pre-medications on rate of infusion reactions - Duration of follow up (in months)
Measured: Median of 12 months in the control and a median of 14 months in the study group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Aug 2020
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Huan Chen, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340764
- Sponsor's protocol ID
- 202007200
- Status last verified
- Aug 2024
- First submitted
- 7 Apr 2022
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abushamma S, Walker T, Garza K, Chen L, Nix D, Chen CH. Accelerated Infliximab Infusion Safety and Tolerability Is Non-inferior to Standard Infusion Protocol in Inflammatory Bowel Disease Patients: A Randomized Controlled Study. Crohns Colitis 360. 2023 May 3;5(3):otad022. doi: 10.1093/crocol/otad022. eCollection 2023 Jul.
PubMed 37288326
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, and Cost-effectiveness of a Reduced Infliximab Infusion Time Protocol
- ClinicalTrials.gov ID
- NCT05340764
- Acronym / sponsor ID
- 202007200
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Remicade is a common medicine used for the treatment of inflammatory bowel disease. This medication is given as an intravenous infusion over 2 hours. Studies have suggested it is safe to give the infusion at a faster rate. The investigators would like to see if the infusion can be given over 1 hour. The investigators expect that increasing the rate of infusion WILL NOT lead to an increase in infusion reactions and will be just as safe and effective as the standard 2 hours dose.
Detailed description
1.1 Infliximab use in IBD
Inflammatory bowel disease (IBD) affects 349 per 100,000 adults in the United States and is associated with significant morbidity and mortality. Infliximab is an effective and commonly used medication to treat patients with IBD, but a main safety concern is an antibody-induced infusion reaction. The incidence of infusion reactions is ~6.5%, with mild, moderate, or severe reactions occurring in 3.1%, 1.2%, and 1% of infusions, respectively. Because of the concern for infusions reactions, infliximab is FDA approved to be infused over 2 hours or more. The typical interval for infusions is every eight weeks but is at times reduced to every 4 weeks in patients with IBD. This infusion time represents a significant inconvenience to patients who receive regular maintenance infusions.
1.2 Accelerated Infliximab Infusions
Multiple studies outside of the United States have demonstrated that a shortened infusion time to one hour, and even thirty minutes is safe and tolerable with similar rates of infusion reactions compared to an infusion time of two hours. However, these studies have differed in dosing, interval, pre-medication allowed in the study, and they are not randomized controlled studies. It has also been shown that reducing infusion times leads to cost savings and increased patient satisfaction. A recent study conducted in the United States at the University of California in San Francisco, confirmed that a shortened infusion time of one hour is safe and tolerated.
1.3 Rationale
The hypothesis is that a shortened infusion time to one hour will be safe and tolerated, with equal infusion reaction rates compared to two-hour infusion
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-hour infusion of infliximab | Active comparator | Drug: Infliximab2 hour infusion of infliximab Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the standard 2 hour infusion of infliximab and serves as the control group. |
| 1-hour infusion of infliximab | Experimental | Drug: Infliximab1 hour infusion of infliximab Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD. Patients in this group received the reduced 1 hour infusion of infliximab and serves as the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be at least 18 years of age
- Must have a diagnosis of IBD
- Must be receiving Infliximab or biosimilar drug infusions for IBD at one of the study infusion centers - Center for Advanced Medicine, Barnes-Jewish West County, Barnes-Jewish South County infusion centers, or receiving infusion through BJC Home Care Services/ Barnes Home Health Company.
- Must tolerate the three induction doses or be tolerating current maintenance dosing without an infusion reaction to qualify for randomization.
Key exclusion criteria (6 listed)
- Those receiving Infliximab for an indication other than IBD (the investigators will include patients receiving infliximab or biosimilar drug for both IBD and an additional autoimmune disease)
- Patients with history of a moderate or severe infusion reactions to infliximab or to an infliximab biosimilar as defined in section 7
- Patients with known antidrug antibodies to infliximab
- Patients who are restarting infliximab (patients who have received infliximab within the past year but have now had an interval greater than 13 weeks between prior dose) must tolerate the three induction doses to qualify for randomization
- Patients receiving an additional infusion concomitant with infliximab (e.g. IV iron)
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 |
|---|---|---|
| InfliximabInfliximab is an effective and commonly used medication to treat patients with IBD | Drug | 1-hour infusion of infliximab, 2-hour infusion of infliximab |
Primary outcome
Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit
Time frame: Median of 12 months in the control and a median of 14 months in the study group.
Acute infusion reaction is defined as any reaction occurring during or within 1 hour after completion of the infusion. It will be separated into mild reactions and moderate/severe reactions as outlined below. Mild/Localized Reaction Pruritus Flushing (facial erythema) Rash/Urticaria Rigors Swelling Moderate/Severe Reaction Fever (temperature > 38.3 degree Celsius) Heart Rate greater than 120 Dyspnea/Shortness of breath Decrease in consciousness Hypotension defined as decrease in baseline SBP by >20 mmHg or SBP <85 Bronchospasm or laryngospasm Anaphylactic shock of one hour, to the standard two-hour infusion.
4 secondary outcomes
Cost Saving Analysis
Time frame: Median of 12 months in the control and a median of 14 months in the study group.
Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Median Number of Infusions
Time frame: Median of 12 months in the control and a median of 14 months in the study group.
Number of Infusions Where Concomitant Immunomodulators and Pre-medications Were Used
Time frame: Median of 12 months in the control and a median of 14 months in the study group.
Effect of Concomitant Immunomodulators and Pre-medications on Rate of Infusion Reactions - Duration of Follow up (in Months)
Time frame: Median of 12 months in the control and a median of 14 months in the study group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37288326Abushamma S, Walker T, Garza K, Chen L, Nix D, Chen CH. Accelerated Infliximab Infusion Safety and Tolerability Is Non-inferior to Standard Infusion Protocol in Inflammatory Bowel Disease Patients: A Randomized Controlled Study. Crohns Colitis 360. 2023 May 3;5(3):otad022. doi: 10.1093/crocol/otad022. eCollection 2023 Jul.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infliximab in people with Inflammatory Bowel Diseases, run by Washington University School of Medicine at 1 site in United States.
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 6 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 29 Aug 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Acute Infusion Reaction as Assessed by the Nursing Staff of the Infusion Unit (time frame: Median of 12 months in the control and a median of 14 months in the study group.). 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 NCT05340764, which also lists 1 linked publication.
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 29 Aug 2024.