Infliximab for Crohn's Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Crohn's DiseaseInfliximab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a computer-driven system for dosing a medication is more effective and safer than standard dosing for Crohn's disease.

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

0 Primary · 12 Secondary · Reporting Duration: week 14, week 26, and week 52

14 weeks
primary non-responders
52 weeks
biological remission
clinical remission
composite biological and endoscopic remission
deep remission
endoscopic remission
endoscopic response
fecal calprotectin
fecal calprotectin change
hs-CRP normalization
sustained CS-free clinical remission
Week 52
hs-CRP change from baseline

Trial Safety

Safety Progress

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

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%Bloody stool
5%Change in appetite
5%Stomach ache
5%Pain in joints
5%Vertigo
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
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

3 Treatment Groups

SOC infliximab dosing
1 of 3
standard of care infliximab dosing
1 of 3
proactive infliximab optimization
1 of 3

Active Control

Experimental Treatment

196 Total Participants · 3 Treatment Groups

Primary Treatment: Infliximab · No Placebo Group · Phase 4

standard of care infliximab dosing
Drug
Experimental Group · 1 Intervention: Infliximab · Intervention Types: Drug
proactive infliximab optimization
Drug
Experimental Group · 1 Intervention: Infliximab · Intervention Types: Drug
SOC infliximab dosingActiveComparator Group · 1 Intervention: SOC infliximab dosing · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 14, week 26, and week 52

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiOTHER
779 Previous Clinical Trials
482,812 Total Patients Enrolled
Beth Israel Deaconess Medical CenterLead Sponsor
775 Previous Clinical Trials
845,634 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
48 Previous Clinical Trials
63,192 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are aged 16 to 80 years inclusive.
Subjects with patchy colonic inflammation initially diagnosed as indeterminate colitis would meet inclusion criteria, if the investigator feels that the findings are consistent with CD.
Elevated CRP > upper limit of normal.
You have elevated fecal calprotectin (> 250 μg/g).
You have received IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.