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Monoclonal Antibodies
Infliximab Optimization for Crohn's Disease
Phase 4
Waitlist Available
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14, week 26, and week 52
Awards & highlights
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.
Who is the study for?
The OPTIMIZE Trial is for males and females aged 16-80 with moderately to severely active Crohn's Disease. Participants must have certain disease markers like elevated CRP or fecal calprotectin, and no prior significant use of Infliximab. Exclusions include those with specific CD complications, infections like tuberculosis or hepatitis B/C, recent serious infections, cancer within the last 5 years (except some skin cancers), immunodeficiency disorders, high-dose steroid use without tapering plans, pregnancy or lactation.Check my eligibility
What is being tested?
This trial tests if using an iDose dashboard-driven dosing method for Infliximab is more effective and safer than standard dosing in achieving and maintaining remission in Crohn's Disease patients. The study compares these two approaches to see which one better controls the symptoms of this digestive disorder.See study design
What are the potential side effects?
Infliximab can cause side effects such as risk of infection due to weakened immune response, allergic reactions including rash and difficulty breathing during infusion, headaches, stomach pain, nausea. It may also increase the risk of developing certain types of cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 14, week 26, and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14, week 26, and week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
biological remission
clinical remission
composite biological and endoscopic remission
+9 moreSide effects data
From 2020 Phase 4 trial • 42 Patients • NCT0300639352%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Change in urination
10%
Fatigue
10%
Heartburn
10%
Nausea
10%
Dizziness
10%
Itchiness
5%
Menstruation
5%
Pain in joints
5%
Migraine
5%
Stomach ache
5%
Syncope
5%
Chest pain
5%
Swelling
5%
Bloody stool
5%
Pain in leg
5%
Allergies
5%
Change in blood pressure
5%
Vertigo
5%
Change in appetite
5%
Numbness
5%
Motor vehicle accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Infliximab
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: standard of care infliximab dosingExperimental Treatment1 Intervention
standard of care infliximab dosing
Group II: proactive infliximab optimizationExperimental Treatment1 Intervention
proactive infliximab optimization using a pharmacokinetic dashboard
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
2017
Completed Phase 4
~3280
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,140 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
57 Previous Clinical Trials
93,722 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
858 Previous Clinical Trials
524,090 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have complications or conditions that would interfere with the study.I am a male or a non-pregnant, non-breastfeeding female aged between 16 and 80.I have been diagnosed with Crohn's disease based on tests.
Research Study Groups:
This trial has the following groups:- Group 1: standard of care infliximab dosing
- Group 2: proactive infliximab optimization
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What precautions should be taken when administering Infliximab to patients?
"Infliximab's safety is well-documented, earning it a score of 3. This Phase 4 trial confirms its approval for patient use."
Answered by AI
Is this research effort currently recruiting participants?
"Clinicaltrials.gov has confirmed that this medical trial, which was first made public on November 1st 2021, is currently seeking participants. The information was last updated on October 4th 2022."
Answered by AI
What pathologies has Infliximab been known to alleviate?
"Infliximab can be employed to tackle poor responses to regular treatment, psoriasis and ankylosing spondylitis."
Answered by AI
What is the aggregate amount of participants involved in this clinical experiment?
"In order to complete this clinical trial, 196 participants need to be recruited who meet the pre-defined inclusion criteria. These individuals can join from facilities such as Milwaukee's Medical College of Wisconsin and Philadelphia's Children Hospital of Pennsylvania."
Answered by AI
Is the clinical trial for this experiment being conducted in multiple Canadian facilities?
"Seventeen hospitals across the U.S are taking part in this medical trial, such as Medical College of Wisconsin (Milwaukee), Children's Hospital of Philadelphia (Philadelphia) and Mount Sinai (Miami)."
Answered by AI
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