Precise Infliximab Exposure and Pharmacodynamic Control

Recruiting now · Phase 2/Phase 3

Conditions studied: Crohn Disease

In brief

Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment. The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).

Key facts

Study ID

NCT05660746

Run by

Children's Hospital Medical Center, Cincinnati

People needed

180

Starts

2023-07-01

Expected to finish

2027-03-31

Last updated by the study team

2026-05-05

Who can join

Age: 6 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is <18 years old
• Written informed assent from patient when age appropriate
• Diagnosis of Crohn's disease within the last 90 days (luminal-only or luminal with a perianal fistula or abscess treated with antibiotics for at least 7 days)
• ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab
• Clinical activity and luminal inflammation, defined by both (1) and (2)
• (1) PCDAI≥10 (<18 years old) or CDAI ≥150 (≥18 years old) in last 60 days before the decision to start infliximab
• (2) SES-CD>6, or SES-CD>3 for isolated ileal disease (or a report of large intestinal ulcerations)* within the last 60 days or a fecal calprotectin >250 μg/g within last 75 days prior to screening
• C-reactive protein >1.0 mg/dL in last 30 days and/or fecal calprotectin >250 μg/g within last 75 days prior to screening
• Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)

You may not qualify if…

• Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
• Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)
• Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days
• Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days
• Active perianal abscess (receiving oral antibiotics for <7 days)
• Intestinal stricture (luminal narrowing with pre-stenotic dilation >3 cm) and surgery planned in the next 90 days
• Have tested positive for Clostridium difficile toxin (stool assay) or other intestinal pathogens within 14 days of screening unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
• Current hospitalization for complications of severe Crohn's disease
• Planned use of methotrexate or 6-mercaptopurine (azathioprine) during the induction (first 3 doses of infliximab) phase
• Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection (>35 cm) or any CD surgery planned within the next 90 days
• History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritis
• Treatment with another investigational drug in the last four weeks
• History of malignancy (including lymphoma or leukemia)
• Currently receiving treatment for histoplasmosis
• History of TB, human immunodeficiency virus (HIV), an immunodeficiency syndrome, a central nervous system demyelinating disease, history of heart failure or receiving intravenous antibiotics in last 14 days for any infection
• Currently pregnant, breast feeding or plans to become pregnant in the next 1 year
• Inability or failure to provide informed assent/consent
• Any developmental disabilities that would impede providing assent/consent

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• Lucile Packard Children's Hospital Stanford — Palo Alto, California, United States (enrolling)
• Rady Children's Hospital San Diego — San Diego, California, United States (enrolling)
• Nemours Children's Health System-Wilmington — Wilmington, Delaware, United States (enrolling)
• Nemours Children's Health System-Jacksonville — Jacksonville, Florida, United States (enrolling)
• Riley Hospital for Children — Indianapolis, Indiana, United States (enrolling)
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic Children's Hospital — Cleveland, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• Children's Specialty Group — Norfolk, Virginia, United States (enrolling)
• Medical College of Wisconsin, Children's of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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