Infliximab for Inflammatory Bowel Diseases

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Washington University School of Medicine, Saint Louis, MO
Inflammatory Bowel Diseases
Infliximab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Inflammatory Bowel Diseases

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Through study completion, an average of 1 year

Year 1
Cost saving analysis
Effect of concomitant immunomodulators and pre-medications on rate of infusion reactions
Number of participants with acute infusion reaction as assessed by the nursing staff of the infusion unit

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Inflammatory Bowel Diseases

Side Effects for

Infliximab
52%Laceration
38%Headache
24%Bruises
19%Sore throat
14%Muscle tension
10%Dizziness
10%Change in urination
10%Nausea
10%Itchiness
10%Fatigue
10%Heartburn
5%Pain in joints
5%Stomach ache
5%Bloody stool
5%Vertigo
5%Change in appetite
5%Allergies
5%Pain in leg
5%Syncope
5%Change in blood pressure
5%Motor vehicle accident
5%Chest pain
5%Numbness
5%Migraine
5%Swelling
5%Menstruation
0%Pain in neck
0%Chills
0%Pregnancy
0%Back pain
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03006393) in the Infliximab ARM group. Side effects include: Laceration with 52%, Headache with 38%, Bruises with 24%, Sore throat with 19%, Muscle tension with 14%.

Trial Design

2 Treatment Groups

2-hour infusion of infliximab
1 of 2
1-hour infusion of infliximab
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Infliximab · No Placebo Group · Phase 4

1-hour infusion of infliximab
Drug
Experimental Group · 1 Intervention: Infliximab · Intervention Types: Drug
2-hour infusion of infliximab
Drug
ActiveComparator Group · 1 Intervention: Infliximab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
2017
Completed Phase 4
~2970

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
Closest Location: Washington University School of Medicine · Saint Louis, MO
Photo of washington university school of medicine 1Photo of washington university school of medicine 2Photo of washington university school of medicine 3
2004First Recorded Clinical Trial
2 TrialsResearching Inflammatory Bowel Diseases
1474 CompletedClinical Trials

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,772 Previous Clinical Trials
2,270,581 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be at least 18 years of age.
You have a diagnosis of IBD.
You are receiving Infliximab or biosimilar drug infusions for IBD at one of the study infusion centers.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.