Clinical Trials / Research Studies

Clinical Trials / Research Studies

Crohn’s Disease Study For Children and Adults 6 to 22 Years Old Starting To Take Infliximab

Why are we doing this research?

Cincinnati Children’s is conducting a research study to determine if a computer program that formulates a dose based on blood testing results can better achieve the optimal drug level as compared to standard dosing. For this study, we are looking at the drug infliximab.

Infliximab is an FDA-approved drug to treat Crohn’s Disease. Currently, dosing of infliximab is based only on weight. However, this method of dosing may increase
the risk of low levels of infliximab in your child’s or your blood and result in poor control of Crohn’s Disease.

Who can participate?

Children, teens and adults 6 to 22 years old who have been diagnosed with Crohn’s disease and are starting treatment with infliximab as part of routine clinical care may be eligible to participate.

Conditions

  • Crohn's Disease and Colitis
  • Gastroenterology, Hepatology and Nutrition

What will happen in the study?

Participation in this study includes a screening visit and up to 8 study visits to Cincinnati Children’s over about 6 months. Here are some things that will happen in this study.

We will collect information from your child’s or your medical records.

Your child or you, as an adult participant, will:

  • Complete questionnaires about stomach pain, stool frequency, and general well-being
  • Have a physical exam
  • Submit blood samples in connection with receiving infliximab
  • Provide stool samples
  • Possibly have urine collected for a pregnancy test
  • Be given the choice to have an MRI

Your child’s or your doses of infliximab will be suggested to your doctor by the computer program. Your child or you will receive infliximab via an IV infusion which will take place at Cincinnati Children’s, which is when most of the study visits will take place.

Before deciding whether to participate in this study, you will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

We cannot promise any benefits to your child, or you, as the participant, or others from your taking part in this study. However, possible benefits include improved control of your or your child’s Crohn’s disease and improved drug durability (longer time on the drug). This study will provide invaluable data regarding future treatment plans for dosing of infliximab.

What are the bad things that can happen from this research?

We will discuss possible risks and discomforts with you prior to the start of the study.

Will you/your child be paid to be in this research study?

Participants will receive up to $290 for your time and effort.

Contact

Contact Us.

Kimberly Jackson
(513) 803-4181
kimberly.jackson@cchmc.org
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.

Phillip Minar, MD, MS
Gastroenterology, Hepatology & Nutrition
Cincinnati Children’s Hospital Medical Center