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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Infliximab is an effective and commonly used medication to treat patients with IBD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Median of 12 months in the control and a median of 14 months in the study group. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Median of 12 months in the control and a median of 14 months in the study group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37288326 | Derived | 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. |
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Patients were excluded if they were receiving infliximab exclusively for a non-IBD indication, had a history of moderate or severe infusion reactions to infliximab (or biosimilar), had known antidrug antibodies to infliximab, had an interval greater than 13 weeks from prior dose of infliximab, were receiving an additional infusion concomitant with infliximab (eg, IV iron), or declined to participate in the trial.
Participants were recruited from 2020 to 2021 and followed throughout the study after enrollment. Patients aged 18 years or older with an established diagnosis of IBD, receiving infliximab at one of our infusions centers and have tolerated the 3 induction doses and current maintenance dosing were eligible for inclusion in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-hour Infusion of Infliximab | 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. |
| FG001 | 1-hour Infusion of Infliximab | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-hour Infusion of Infliximab | 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. |
| BG001 | 1-hour Infusion of Infliximab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age was 47 (SD 15.5) in both groups in the trial. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Median of 12 months in the control and a median of 14 months in the study group. |
|
Up to 16 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2-hour Infusion of Infliximab | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chien-Huan Chen | Washington University School of Medicine GI Division | 3143623201 | chen330@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2022 | Feb 13, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2022 | Feb 13, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| 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 | 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 | 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) | Median of 12 months in the control and a median of 14 months in the study group. |
1 hour infusion of infliximab Infliximab: Infliximab is an effective and commonly used medication to treat patients with IBD |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Inflammatory Bowel Disease Type | Count of Participants | Participants |
|
| Concomitant Immunomodulator | Count of Participants | Participants |
|
| OG001 | 1-hour Infusion of Infliximab | 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. |
|
|
| Secondary | 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. | Posted | Mean | Full Range | dollars | Median of 12 months in the control and a median of 14 months in the study group. |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | Infusions | Median of 12 months in the control and a median of 14 months in the study group. |
|
|
|
| Secondary | 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 | Posted | Count of Units | Total number of infusions | Median of 12 months in the control and a median of 14 months in the study group. | Total number of infusions | Total number of infusions |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | months | Median of 12 months in the control and a median of 14 months in the study group. |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | 1-hour Infusion of Infliximab | 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| MTX |
|
| None |
|
| Diphenhydramine |
|
| Loratidine |
|
| Ondansetron |
|
| Methylprednisolone |
|