Clinical trial NCT05340764
Conditions: Inflammatory Bowel Diseases
Sponsor: Washington University School of Medicine
Start date: 2020-08-01; Completion date: 2023-05-04
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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. 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

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Infliximab
Intervention descriptions: intervention 1: Infliximab is an effective and commonly used medication to treat patients with IBD

Protocol documents:
Prot_SAP_000.pdf: 
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WUSTL.V1.A3 May 5, 2022 
 
 
Safety, efficacy, and cost-effectiveness of a reduced Infliximab infusion protocol 
 
 
Principal Investigator:  
Chien-Huan Chen, M.D., PhD. 
Division of Gastroenterology 
Washington University in St Louis School of Medicine 
660 South Euclid Ave 
St Louis MO 63110 
 
Coordinating Center: 
Washington University School of Medicine 
 
Co-Investigators:    
Suha Abushamma, M.D. 
 
 
Study Coordinator: 
Suha Abushamma, M.D. 
Statistician:  
 
To be determined 
 
 
 
Protocol Version: 1 
Amendment: 3 
Protocol Date: May 5, 2022 
 
 
 
 
 
 


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WUSTL.V1.A3 May 5, 2022 
 
Safety, efficacy, and cost-effectiveness of a reduced Infliximab infusion protocol 
 
 
Principal Investigator Signature Page 
 
Principal Investigator (printed):
      
Name of Institution:
      
 
PI Signature 
 
 
 
 
 
Date 
By my signature, I agree to personally supervise the conduct of this 
study and to ensure its conduct in compliance with the protocol, 
informed consent, IRB/HRPO procedures, the Declaration of 
Helsinki, ICH Good Clinical Practices guidelines, and the 
applicable parts of the United States Code of Federal Regulations 
or local regulations governing the conduct of clinical studies. 
 
 
 
 


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TABLE OF CONTENTS 
 
1 
Background and Rationale ................................................................................ 4 
1.1 
Infliximab use in IBD ..................................................................................................... 4 
1.2 
Accelerated Infliximab Infusions .................................................................................... 4 
1.3 
Rationale ......................................................................................................................... 4 
2 
Objectives ........................................................................................................... 4 
2.1 
Primary Objective ........................................................................................................... 4 
2.2 
Secondary Objectives ..................................................................................................... 4 
3 
Eligibility Criteria ................................................................................................ 5  
3.1 
Inclusion Criteria ........................................................................................................... 5 
3.2 
Exclusion Criteria ........................................................................................................... 5 
3.3 
Inclusion of Women and Minorities ............................................................................ 5 
4 
REGISTRATION PROCEDURES ........................................................................ 5 
4.1 
Confirmation of Patient Eligibility ................................................................................. 5 
4.2 
Assignment of UPN ........................................................................................................ 5 
4.3 
Randomization ............................................................... Error! Bookmark not defined. 
5 
Study Procedures ............................................................................................... 6 
5.1 
Recruitment .................................................................................................................... 6 
5.2 
Intervention .................................................................................................................... 6 
6 
REGULATORY AND REPORTING REQUIREMENTS ........................................ 6 
7 
Data and Safety Monitoring Plan ....................................................................... 7 
8 
Statistical Considerations ................................................................................. 8 
8.1 
Sample Size Calculations ................................................................................................ 8 
8.2 
Analysis methods ............................................................................................................ 8 
 
References .......................................................................................................... 8 
 
 


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1 
Background and Rationale 
 
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 [1-2]. Infliximab is an effective and commonly 
used medication to treat patients with IBD, but a main safety concern is an antibody-induced 
infusion reaction [3]. 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 [4]. 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 [3].  
 
 
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 [5-13]. 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 [14]. 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 [15].  
 
 
1.3 
Rationale 
 
Our 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.   
 
 
2 
Objectives  
 
2.1 
Primary Objective 
 
To compare the safety and tolerability (infusion reaction rate) of an infliximab infusion time of 
one hour versus the standard two-hour infusion.   
 
2.2 
Secondary Objectives 
 
1. Cost savings analysis of shortened infliximab infusion time 
2. Assess effect of concomitant immunomodulators and premedications on rate of infusion 
reactions 
 
 
 


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3 
Eligibility Criteria 
 
3.1 
Inclusion Criteria 
 
1. Must be at least 18 years of age 
2. Must have a diagnosis of IBD 
3. Must be receiving Infliximab or biosimilar drug infusions for IBD at one of our infusion centers 
– Center for Advanced Medicine, Barnes-Jewish West County, or Barnes-Jewish South County 
infusion centers, or BJC home pharmacy 
4. Must tolerate the three induction doses or be tolerating current maintenance dosing without an 
infusion reaction to qualify for randomization. 
 
3.2 
Exclusion Criteria 
 
1. Those receiving Infliximab for an indication other than IBD (we will include patients receiving 
infliximab or biosimilar drug for  both IBD and an additional autoimmune disease) 
2. Patients with history of a moderate or severe infusion reactions to infliximab or to an 
infliximab biosimilar as defined in section 7 
3. Patients with known antidrug antibodies to infliximab 
4. 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 
5. Patients receiving an additional infusion concomitant with infliximab (e.g. IV iron) 
6. Patients who decline to participate in the trial 
 
 
3.3 
Inclusion of Women and Minorities 
 
Both men and women and members of all races and ethnic groups are eligible for this trial. 
 
 
 
 
4 
REGISTRATION PROCEDURES 
 
 
4.1 
Confirmation of Patient Eligibility 
 
Confirm patient eligibility by collecting the information listed below through review of the electronic 
medical record (EMR). 
 
1. Patient name and contact information (telephone number, fax number and email address) 
2. Patient’s age, race, sex, and DOB 
3. Diagnosis of IBD 
4. Infliximab infusion history 
5. Assessment for exclusion criteria listed in 3.2 
 
 
4.2 
Assignment of UPN 
 
Each patient will be identified with a unique patient number (UPN) for this study.  Patients will also 
be identified by first, middle, and last initials.  If the patient has no middle initial, a dash will be used. 
 


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WUSTL.V1.A3 May 5, 2022 
 
4.3 
Patient assignment  
 
Consenting and eligible participants will be randomly assigned to one of two arms using a research 
randomization tool. There will be one control arm and one intervention arm. Participants in the first 
arm will undergo a traditional infusion time of two hours. The second arm will be patients who 
undergo an infusion time of one hour. Infusion reaction will be recorded. Patients from the 
intervention groups who have a moderate or severe infusion reaction, as defined in section 7, will 
be removed from the intervention groups back to 2-h infusions. Their subsequent infusions will not 
be included in the final analysis of 2-h infusions.   
 
 
5 
Study Procedures 
 
5.1 
Recruitment 
 
Adult patients with IBD who are receiving or are scheduled to start infliximab infusions will be 
screened for inclusion in the study. Patients will be identified from the gastroenterology clinic as 
well as outpatient infusion centers in the Center for Advanced Medicine, Barnes-Jewish West 
County, or Barnes-Jewish South County locations. Those subjects who qualify for the study 
based on inclusion/ exclusion criteria will be invited to participate. Once eligibility is confirmed, the 
patient will be contacted by phone, or in person in the clinic or infusion center, by one of the 
members of the research team. They will discuss the purpose of the study, the three arms, risks, 
and benefits of the study using an approved phone script. The patient will then be invited to 
participate. The consent process will take place over the phone when the patient is contacted or 
in person when they present for an infusion. Those patients who wish to participate will provide 
verbal consent. They will then proceed with the scheduled infusions. Patient allocation will take 
place after the patient is consented and before the day of the infusion. 
 
5.2 
Intervention 
 
After consent is obtained the patients will be assessed for appropriateness of a shortened 
infusion time. Patient that have tolerated their three induction doses without an infusion reaction, 
as well as patients who are already on maintenance dosing and do not have a history of an 
infusion reaction, will be randomized to either receive a one hour infusion of infliximab, or to stay 
on the standard 2-h infusion. Infusion reactions will be recorded for each group as outlined in 
section 7. Additional information including IBD type, demographic information, pre-medication 
use, and concomitant immunomodulator therapy will be recorded as well. All infusion doses as 
well as infusion intervals will be eligible for inclusion in the study. Drug dosing and intervals will be 
determined by the prescribing physician and left to their discretion.   
 
Patients in the intervention group who develop a moderate or severe infusion reaction as defined 
in section 7 will be removed from the intervention group and placed back on 2-h infusions. These 
future infusions will not be included in the study. Patients with a mild infusion reaction will 
continue in their assigned group (intervention or control). 
 
 
6 
REGULATORY AND REPORTING REQUIREMENTS 
 
Rates of infusion reactions will be continuously recorded and reported to an oversight committee to allow 
for safety monitoring.  
 
 
 


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7 
Data and Safety Monitoring Plan 
 
Acute infusion reactions will be defined as any reaction occurring during or within 1 hour after completion 
of the infusion. They will be separated into mild reactions and moderate/severe reactions as outlined 
below.  
1. Mild/Localized Reaction 
a. Pruritus  
b. Flushing (facial erythema) 
c. Rash/Urticaria 
d. Rigors 
e. Swelling 
2. Moderate/Severe Reaction 
a. Fever (temperature > 38.3 degree Celsius) 
b. Heart Rate greater than 120 
c. Dyspnea/Shortness of breath 
d. Decrease in consciousness 
e. Hypotension defined as decrease in baseline SBP by >20 mmHg or SBP <85 
f. 
Bronchospasm or laryngospasm 
g. Anaphylactic shock 
The treatment plan for infusion reactions will be as follows: 
1. Mild/Localized Reaction 
a. Pruritus, flushing, rash, or swelling 
i. Stop infusion 
ii. Administer diphenhydramine 25mg IV x 1 
iii. Administer famotidine 20mg IV x 1 
iv. Repeat steps ii, and iii x 1 PRN if no symptom improvement after 15 min. 
v. Notify MD 
vi. Vital signs every 15 minutes until symptoms resolve 
vii. After symptom resolution, restart infusion at 50% of previous rate 
b. Rigors 
i. Stop infusion 
ii. Administer meperidine 25mg IV x 1 only (not to be given if greater than 2 hours 
post infusion cessation) 
iii. Notify MD 
iv. Vital signs every 15 minutes until symptoms resolve 
v. After symptom resolution, restart the infusion at 50% of previous rate 
2. Moderate to Severe Reactions 
a. Stop infusion 
b. Administer diphenhydramine 50mg IV x 1 
c. Administer methylprednisolone 125mg IV x 1 
d. Administer famotidine 20mg IV x 1 
e. Repeat steps b, c, and d x 1 PRN if symptoms do not resolve within 15 min. 
f. 
If hypotension occurs (decrease in baseline SBP by >20 mmHg or SBP <85mmHg 
i. Administer epinephrine (1:1000) 0.3mg IM x 1. Repeat x 1 PRN if hypotension 
does not resolve within 15 min. 
g. Administer normal saline IV, wide open 
h. Place nasal cannula oxygen at 2L/minute 
i. 
Notify MD 


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WUSTL.V1.A3 May 5, 2022 
 
j. 
Check vital signs every 5 minutes until stable, then every 15 minutes until symptoms 
resolve 
k. The time and rate of infusion restart to be determined by MD 
 
 
8 
Statistical Considerations  
 
8.1 
Sample Size Calculations 
 
Our sample size calculation was based on an infusion reaction rate of 3%, as suggested by 
recent studies. In order to show a non-inferiority of the accelerated infusion time assuming an 
infusion reaction rate of 3% while allowing for a 12% non-inferiority limit, a total of 90 patients (45 
in each group) would be needed. This would provide a power of 80% and significant alpha of 
0.05. 
   
8.2 
Analysis methods 
 
This study will collect both categorical and quantitative demographic variables, infusion details, and 
infusion reaction details. Premedication details and comcomitant immonomodulator therapy will 
also be recorded. All information will be transferred into an encrypted database. The categorical 
variables will be summarized using frequencies and percents, while the quantitative variables will 
be summarized using means and standard deviations. Chi square test will be used for categorical 
variables while student’s t test will be used for quantitative variables to test the difference between 
the study groups. Additionally, multivariable analysis will be used in order to identify factors 
associated with an increased risk of infusion reaction. The statistical software program SPSS will 
be used for analysis. A two-sided p value of < 0.05 will be considered significant. 
 
 
9 
References  
 
1. Kappelman MD, Rifas-Shiman SL, Kleinman K, et al The prevalence and geographic distribution of 
Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007;5:1424-9. 
2. Langholz E. Current trends in inflammatory bowel disease: the natural history. Ther Adv Gastroenterol. 
2010;3:77-86 
3. REMICADE (infliximab) [package insert]. Janssen Biotech, Inc: Horsham, PA. Revised on June 2018. 
4. Cheifetz A, Smedley M, Martin S, et al The incidence and management of infusion reactions to 
infliximab: a large center experience. Am J Gastroenterol. 2003;98:1315-24. 
5. Breynaert C, Ferrante M, Fidder H, et al Tolerability of shortened infliximab infusion times in patients 
with inflammatory bowel diseases: a single-center cohort study. Am J Gastroenterol. 2011;106:778-85. 
6. Clare DF, Alexander FC, Mike S, et al Accelerated infliximab infusions are safe and well tolerated in 
patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2009;21:71-5. 
7. Lee TW, Singh R, Fedorak RN. A one-hour infusion of infliximab during maintenance therapy is safe 
and well tolerated: a prospective cohort study. Aliment Pharmacol Ther. 2011;34:181-7. 
8. McConnell J, Parvulescu-Codrea S, Behm B, et al Accelerated infliximab infusions for inflammatory 
bowel disease improve effectiveness. World J Gastrointest Pharmacol Ther. 2012;3:74-82. 
9. Belhassan M, Zeitoun JD, Lefevre JH, et al Infliximab infusion time in patients with inflammatory bowel 
diseases: is longer really safer? Clin Res Hepatol Gastroenterol. 2013;37:189-92. 
10. Neef HC, Riebschleger MP, Adler J. Meta-analysis: rapid infliximab infusions are safe. Aliment 
Pharmacol Ther. 2013;38:365-76. 
11. Babouri A, Roblin X, Filippi J, et al Tolerability of one hour 10 mg/kg infliximab infusions in 
inflammatory bowel diseases: a prospective multicenter cohort study. J Crohns Colitis. 2014;8:161-5. 


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12. Van Assche G, Vermeire S, Noman M, et al Infliximab administered with shortened infusion times in a 
specialized IBD infusion unit: a prospective cohort study. J Crohns Colitis. 2010;4:329-33. 
13, Rozette NA, Hellauer CM, McKee C, et al Evaluation of Rapid vs Standard Infliximab Infusions in the 
Pediatric Population. Inflamm Bowel Dis. 2018;24(9):2007-2014.  
14. Mazzuoli S, Tricarico D, Demma F, et al Accelerated infliximab infusion: safety, factors predicting 
adverse events, patients' satisfaction and cost analysis. A cohort study in IBD patients. PLoS ONE. 
2016;11:e0166443. 
15. Ma D, Wong W, et. Al. Safety and Tolerability of Accelerated Infliximab Infusions in Patients with 
Inflammatory Bowel DIsease. Am J Gastroenterol. 2019;114(2):352-354. 

ICF_001.pdf: 
 
FOR IRB USE ONLY 
IRB ID #: 202007200 
APPROVAL DATE: 07/01/22 
RELEASED DATE: 07/01/22 
EXPIRATION DATE: 06/30/23
 
 
 
INFORMED CONSENT DOCUMENT 
 
Project Title: 
Safety, efficacy, and cost-effectiveness of a reduced Infliximab infusion protocol 
 
Principal Investigator: 
Chien-Huan Chen 
 
Research Team Contact: 
Suha Abushamma , 314-482-1947 
 
 
This consent form describes the research study and helps you decide if you want to participate.  It provides 
important information about what you will be asked to do during the study, about the risks and benefits of 
the study, and about your rights and responsibilities as a research participant.  
 You should read and understand the information in this document including the procedures, 
risks and potential benefits.  
 If you have questions about anything in this form, you should ask the research team for more 
information before you agree to participate.   
 You may also wish to talk to your family or friends about your participation in this study. 
 Do not agree to participate in this study unless the research team has answered your questions 
and you decide that you want to be part of this study.  
 
WHAT IS THE PURPOSE OF THIS STUDY? 
 
This is a research study.  We invite you to participate in this research study because you are a patient 
receiving infliximab (Remicade) or biosimilar drug infusions at one of our infusion centers for 
inflammatory bowel disease. The purpose of this research study is to see if we can safely and effectively 
shorten the time it takes to complete your infusion. We are doing this by having some patients shorten 
their infusion time from the normal 2-hour infusion, to a faster 1 hour infusion. 
 
Infliximab (Remicade) and biosimilar drugs are approved by the U.S. Food and Drug Administration to 
treat inflammatory bowel disease (e.g., Crohn’s Disease, Ulcerative Colitis).  
 
WHAT WILL HAPPEN DURING THIS STUDY? 
 
If you agree to participate, you would be randomly (by chance, like rolling dice) assigned to one of two 
groups. The first group of patients will have their infusion time shortened from 2 hours to 1 hour. The 
second group of patients will have their infusion time unchanged and will continue to receive their 
infusions as they normally would over 2 hours. Patients are assigned to each of these groups through a 
random computer randomizer. You have an equally likely chance to be assigned to either of these 2 
groups. Once you are assigned to one of the groups, you will continue to receive your infusions as 
prescribed by your Gastroenterologist at the rate you are assigned for as long as the accelerate protocol 
continues (6 months).  At the completion of the study, your infusions will return to the normal 2 hour 
infusion time. The timing interval and dose of your infusion will not change unless changed by the 
prescribing physician.  
 


 
FOR IRB USE ONLY 
IRB ID #: 202007200 
APPROVAL DATE: 07/01/22 
RELEASED DATE: 07/01/22 
EXPIRATION DATE: 06/30/23
 
 
Page 2 of 8 
All patients will receive standard monitoring during their infusion. We will monitor patients and record 
any infusion reactions that occur during or within 1 hour of your infusion. The purpose of our study is to 
compare the number of the infusion reactions in the shortened infusion group to the standard 2-hour 
group. We do not expect that there will be any increased incidence of infusion reactions based on the 
results of several preliminary studies done elsewhere.  
 
Will you save my research information to use in future research studies? 
 
 Identifiers may be removed from your private information and used for future research or shared 
with others. If this occurs, we will not ask you for additional consent.  
 
HOW MANY PEOPLE WILL PARTICIPATE? 
 
Approximately 300 people will take part in this study conducted by investigators at Washington 
University.   
 
HOW LONG WILL I BE IN THIS STUDY? 
 
If you agree to take part in this study, your involvement will last for as long as you are receiving your 
infliximab (Remicade) or biosimilar drug infusions. 
 
WHAT ARE THE RISKS OF THIS STUDY? 
 
You may experience one or more of the risks indicated below from being in this study. In addition to these, 
there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.  
 
Some risks described in this consent document, if severe, may cause death.  
 
Infusion Reaction 
The goal of our study is to assess the safety of using faster infusion times for infliximab (Remicade) or 
biosimilar drugs. There is a theoretical risk that increasing the rate of your infusion could increase the risk 
for having an infusion reaction. Infusion reactions can range from mild, such as itching, flushing, or chills, 
to severe reactions such as increased heart rate, shortness of breath, low blood pressure, or anaphylaxis 
(severe allergic reaction). Recent studies have compared faster infusion times to the normal 2-hour 
infusion, and these studies have shown that there is no increased risk for having an infusion reaction in the 
faster infusion times. We believe that the shortened infusion time will be safe without any increased risk of 
any infusion reactions. 
 
For patients that do have an infusion reaction, there is an established protocol which involves stopping the 
infusion, increased monitoring, and possible medications depending on the type of reaction that you 
experience. If you are receiving the medication at the faster infusion time and have an infusion reaction 
that is moderate or severe, your infusion time will be changed back to the standard 2-hour infusion for the 
duration of the study. 
 
Infliximab (Remicade) or biosimilar drug 
This medication has been associated with side effects, including serious side effects with the potential to 


 
FOR IRB USE ONLY 
IRB ID #: 202007200 
APPROVAL DATE: 07/01/22 
RELEASED DATE: 07/01/22 
EXPIRATION DATE: 06/30/23
 
 
Page 3 of 8 
cause death.  As part of your standard of clinical care, your gastroenterologist will discuss the risks 
associated with this medication prior to enrollment into this study. 
 
More Common Side Effects: 
Mild:  The most common side effects of infliximab (Remicade) or biosimilar drug are:  upper respiratory 
infectsions (such as a sinus infections or sore throat), headache, cough, or pain in the abdomen (belly).  
Most of these side effects may go away within a few days or a couple of weeks. But if they become more 
severe or don’t go away, talk with your doctor or pharmacist.  
 
Serious Side Effects: 
Serious side effects from Remicade aren’t common, but they can occur. Call your doctor right away if you 
have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a 
medical emergency. 
 
Infusion reactions – either while receiving an infusion or a within a few hours after an infusion – can 
include symptoms of allergic reaction, such as rash/itching; flushed skin; swelling of the face, lips, tongue, 
or throat; difficulty breathing; dizziness; or a fast heart rate. If severe, the allergic reaction can cause death. 
 
Infections. Serious infections such as tuberculosis or disseminated fungal infections have occurred in 
patients receiving infliximab or biosimilar drug 
 
Malignancy. Use of infliximab or biosimilar drug has been associated with increased risk of lymphoma 
 
New or worsening heart failure. Symptoms can include: shortness of breath, edema (swelling, typically in 
your ankles and feet), sudden weight gain 
 
Heart attack. Symptoms can include: chest pain or discomfort, arm pain, shortness of breath, anxiety, 
lightheadedness or fainting, sweating, or nausea or vomiting 
 
Abnormal heart rhythms. Symptoms can include: fast or slow heart rate, fluttering heart rate, pounding in 
the chest 
 
Stroke. Symptoms can include: weakness on one side of the body confusion, trouble speaking or 
understanding others, trouble seeing in one or both of the eyes, trouble standing or walking, dizziness, 
severe headache 
 
Liver problems. Symptoms can include: tiredness, fever, jaundice (yellowing of your skin and the white of 
your eyes), dark-colored urine, pain on the right side of your belly 
 
Blood disorders, such as a low level of white blood cells. Symptoms can include: bruising or bleeding 
easily, pale skin, fever that lasts longer than 48 hours, frequent infections 
 
Nervous system disorders, such as seizures or vision problems. Symptoms can include: numbness or 
tingling of body parts, weakness in your arms or legs, vision loss or changes in how you see color 
 


 
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IRB ID #: 202007200 
APPROVAL DATE: 07/01/22 
RELEASED DATE: 07/01/22 
EXPIRATION DATE: 06/30/23
 
 
Page 4 of 8 
New or worsening psoriasis (a condition in which itchy, red patches form on your skin). Symptoms 
include: scaly, red patches on skin, raised bumps on skin that are filled with pus. 
 
Breach of Confidentiality 
One risk of participating in this study is that confidential information about you may be accidentally 
disclosed.  We will use our best efforts to keep the information about you secure.  Please see the section in 
this consent form titled “How will you keep my information confidential?” for more information. 
 
WHAT ARE THE BENEFITS OF THIS STUDY? 
 
You may or may not benefit from being in this study.   
 
However, we hope that, in the future, other people might benefit from this study because it would 
significantly reduce the inconvenience to patients who receive regular maintenance infusions if it can be 
shown that infusion rates can be safely increased for these patients. 
 
WHAT OTHER TREATMENT OPTIONS ARE THERE? 
 
Before you decide whether or not to be in this study, your doctor will discuss the other options that are 
available to you.  Instead of being in this study, you could continue to receive the standard 2-hour infusion. 
 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY? 
 
You will not have any costs for being in this research study. 
 
You and/or your medical/hospital insurance provider will remain responsible for your regular medical 
care expenses. 
 
WILL I BE PAID FOR PARTICIPATING? 
 
You will not be paid for being in this research study.   
 
WHO IS FUNDING THIS STUDY? 
 
The University and the research team are not receiving payment from other agencies, organizations, or 
companies to conduct this research study.  
 
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY? 
 
Washington University investigators and staff will try to reduce, control, and treat any complications from 
this research. If you feel you are injured because of the study, please contact the investigator at 
314-482-1947 and/or the Human Research Protection Office at 1-(800)-438-0445.  
 
Decisions about whether payment for medical treatment for injuries relating to your participation in 
research will be made by Washington University.  If you need to seek medical care for a research-related 
injury, please notify the investigator as soon as possible.  


 
FOR IRB USE ONLY 
IRB ID #: 202007200 
APPROVAL DATE: 07/01/22 
RELEASED DATE: 07/01/22 
EXPIRATION DATE: 06/30/23
 
 
Page 5 of 8 
 
HOW WILL YOU KEEP MY INFORMATION CONFIDENTIAL? 
 
Other people such as those indicated below may become aware of your participation in this study and may 
inspect and copy records pertaining to this research.  Some of these records could contain information that 
personally identifies you. We will keep your participation in this research study confidential to the extent 
permitted by law.   
 Government representatives (including the Office for Human Research Protections) to complete 
federal or state responsibilities 
 The U.S. Food and Drug Administration 
 Hospital or University representatives to complete Hospital or University responsibilities 
 Information about your participation in this study may be documented in your health care records 
and will be available to anyone with access to your health care record, including your health 
insurance company.  This information may also be released as part of a release of information 
request. 
 The last four digits of your social security number may be used in hospital or University systems to 
track billing information for research procedures. 
 Washington University’s Institutional Review Board (a committee that oversees the conduct of 
research involving human participants) and the Human Research Protection Office. The 
Institutional Review Board has reviewed and approved this study.  
 Any report or article that we write will not include information that can directly identify you.  The 
journals that publish these reports or articles require that we share your information that was 
collected for this study with others to make sure the results of this study are correct and help 
develop new ideas for research. Your information will be shared in a way that cannot directly 
identify you. 
 
To help protect your confidentiality, we will store all hard copies in a safe locked cabinet which can only 
be accessed by team members of the research study.  To maintain patient confidentiality, the computer 
which will be utilized for data analysis is password protected and in a locked facility.  Password encrypted 
files will be used for transfer of information. Each patient will be identified with a unique patient number 
(UPN) for this study.  Patients will also be identified by first, middle, and last initials.  If the patient has no 
middle initial, a dash will be used. 
 
Are there additional protections for my health information? 
Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal 
law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this research, 
you must give the research team permission to use and disclose (share) your PHI for the study as explained 
in this consent form.  The research team will follow state and federal laws and may share your health 
information with the agencies and people listed under the previous section titled, “How will you keep my 
information confidential?” 
 
Once your health information is shared with someone outside of the research team, it may no longer be 
protected by HIPAA.   
 


 
FOR IRB USE ONLY 
IRB ID #: 202007200 
APPROVAL DATE: 07/01/22 
RELEASED DATE: 07/01/22 
EXPIRATION DATE: 06/30/23
 
 
Page 6 of 8 
The research team will only use and share your information as talked about in this form or as permitted or 
required by law.  When possible, the research team will make sure information cannot be linked to you 
(de-identified).  Once information is de-identified, it may be used and shared for other purposes not 
discussed in this consent form. If you have questions or concerns about your privacy and the use of your 
PHI, please contact the University’s Privacy Officer at 866-747-4975.  
 
Although you will not be allowed to see the study information, you may be given access to your health care 
records by contacting your health care provider.  
 
If you decide not to sign this form, it will not affect 
 Your treatment or the care given by your health provider. 
 Your insurance payment or enrollment in any health plans.   
 Any benefits to which you are entitled. 
 
However, it will not be possible for you to take part in the study. 
 
If you sign this form: 
 You authorize the use of your PHI for this research. 
 This authorization does not expire. 
 You may later change your mind and not let the research team use or share your information (you 
may revoke your authorization).  
 To revoke your authorization, complete the withdrawal letter, found in the Participant section 
of the Human Research Protection Office website at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may request that the 
investigator send you a copy of the letter.    
 
 
 
o If you revoke your authorization: 
 The research team may only use and share information already collected for the 
study. 
 Your information may still be used and shared as necessary to maintain the 
integrity of the research, for example, to account for a participant’s withdrawal 
from the research study or for safety reasons. 
 You will not be allowed to continue to participate in the study. 
 
IS BEING IN THIS STUDY VOLUNTARY? 
 
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If you 
decide to be in this study, you may stop participating at any time. Any data that was collected as part of 
your participation in the study will remain as part of the study records and cannot be removed.   
 
If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or lose 
any benefits for which you otherwise qualify.   
 


 
FOR IRB USE ONLY 
IRB ID #: 202007200 
APPROVAL DATE: 07/01/22 
RELEASED DATE: 07/01/22 
EXPIRATION DATE: 06/30/23
 
 
Page 7 of 8 
What if I decide to withdraw from the study? 
 
You may withdraw by telling the study team you are no longer interested in participating in the study or 
you may send in a withdrawal letter. A sample withdrawal letter can be found at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a Research 
Study. 
 
Will I receive new information about the study while participating? 
 
If we obtain any new information during this study that might affect your willingness to continue 
participating in the study, we’ll promptly provide you with that information. 
 
Can someone else end my participation in this study? 
 
Under certain circumstances, the investigator might decide to end your participation in this research study 
earlier than planned.  This might happen for no reason or because in our judgement it would not be safe to 
continue infusion reactions at an accelerated rate because it is unsafe, or if your condition worsens 
necessitating changing of medication 
 
WHAT IF I HAVE QUESTIONS? 
 
We encourage you to ask questions.  If you have any questions about the research study itself, please 
contact: Suha Abushamma, 314-482-1947.  If you experience a research-related injury, please contact: 
Suha Abushamma, 314-482-1947. 
 
If you have questions, concerns, or complaints about your rights as a research participant, please contact 
the Human Research Protection Office 1-(800)-438-0445, or email hrpo@wustl.edu.   General 
information about being a research participant can be found on the Human Research Protection Office 
web site, http://hrpo.wustl.edu.  To offer input about your experiences as a research participant or to speak 
to someone other than the research staff, call the Human Research Protection Office at the number above. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 202007200 
APPROVAL DATE: 07/01/22 
RELEASED DATE: 07/01/22 
EXPIRATION DATE: 06/30/23
 
 
Page 8 of 8 
This consent form is not a contract. It is a written explanation of what will happen during the study if you 
decide to participate. You are not waiving any legal rights by agreeing to participate in this study. As a 
participant you have rights and responsibilities as described in this document and including: 
 To be given enough time before signing below to weigh the risks and potential benefits and decide 
if you want to participate without any pressure from the research team or others. 
 To understand all of the information included in the document, have your questions answered, and 
receive an explanation of anything you do not understand. 
 To follow the procedures described in this document and the instructions of the research team to 
the best of your ability unless you choose to stop your participation in the research study. 
 To give the research team accurate and complete information. 
 To tell the research team promptly about any problems you have related to your participation, or if 
you are unable to continue and wish to stop participating in the research study. 
 
Your signature indicates that this research study has been explained to you, that your questions have been 
answered, and that you agree to take part in this study.  You will receive a signed and dated copy of this 
form. 
 
 
Do not sign this form if today’s date is after EXPIRATION DATE: 06/30/23. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Participant) 
 
 
 
 
(Date) 
 
 
____________________________________________ 
(Participant's name – printed) 
 
 
 
 
Statement of Person Who Obtained Consent 
 
The information in this document has been discussed with the participant or, where appropriate, with the 
participant’s legally authorized representative.  The participant has indicated that they understand the 
risks, benefits, and procedures involved with participation in this research study. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Person who Obtained Consent) 
 
(Date) 
 
 
___________________________________________ 
(Name of Person who Obtained Consent - printed)