Infliximab Optimization for Crohn's Disease

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests if using a computer program to decide infliximab doses is better and safer than standard dosing for patients with inflammatory bowel disease. The program helps doctors choose the best dose by looking at individual health details, aiming to keep the medication working well and prevent the disease from getting worse. Infliximab is commonly used to treat inflammatory bowel disease, and dose optimization has been shown to improve treatment outcomes.

Eligibility Criteria

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.

Inclusion Criteria

Moderately to severely active CD, defined by a total Crohn's Disease Activity Index (CDAI) score between 220 and 450 points, and at least 1 of the following: Elevated CRP > upper limit of normal, Elevated fecal calprotectin (FC) (> 250 μg/g), SES-CD > 6, or SES-CD > 3 for isolated ileal disease, Physician intends to prescribe IFX as part of the usual care of the subject, No previous use of IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.5 weeks of enrolment) and met all eligibility criteria at the time of starting IFX and IFX was administered according to the requirements outlined in this protocol, Able to participate fully in all aspects of this clinical trial, Written informed consent must be obtained and documented

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.

Exclusion Criteria

I do not have complications or conditions that would interfere with the study.

Participant Groups

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.

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

Infliximab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Remicade for: