About REMODEL-CD
Study Background
Infliximab is a medication that is FDA-approved to treat Crohn’s disease in patients 6 years and up. It is an anti-TNF biologic medication that is given as an intravenous (IV) infusion at set intervals.
While many patients improve while receiving infliximab, there are some patients who require higher doses or more frequent infusions than the standard treatment.
Past studies have suggested that a more tailored approach to dosing may improve a patient’s long-term outcomes.
Our research team has developed a new dosing strategy that relies on innovative technology to help guide doctors to prescribe the best dose and regimen for the individual patient starting from the first dose.
Study Details
Our clinical trial will study this new method of dosing infliximab versus the standard method of dosing infliximab. We will compare the results between the two groups after all enrolled participants have received one year of treatment. The trial is being conducted at 10 medical centers in the United States.
The study goal is to enroll 180 participants.
Five centers will use the standard method of dosing infliximab.
Five centers will use the new method of dosing infliximab.
All participants enrolled in the study will receive infliximab at their center at no cost for up to one year.
All participants will have a repeat colonoscopy after one year of treatment.
Who is Eligible for the Trial?
Ultimately, your child’s doctor will make the final decision about study eligibility. A parent or primary guardian will need to sign consent for the trial for children up to 18 years old, and patients who are age 18 and older will sign their own consent form. The following includes eligibility guidelines for you and your doctor to consider:
Children and young adults 6 to 22 years old.
Recent diagnosis (last 90 days) of Crohn’s disease.
Active inflammation detected during a routine colonoscopy or stool test.
You and your doctor have made the decision to start infliximab infusions.
Not all patients will qualify for this study. The specific eligibility criteria will be discussed with your doctor and clinical research coordinator at the participating centers.