Precise Infliximab Exposure and Pharmacodynamic Control

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Dec 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to give treatment for Crohn's Disease, a condition that affects the digestive system. The researchers want to find out if using a special computer program that calculates the best dose of the medication infliximab based on a patient's blood test results (called precision dosing) can lead to better health outcomes compared to the usual method of giving a standard dose. The trial aims to improve how doctors decide on treatment, especially since many people with Crohn's Disease have limited options.

To be eligible for this study, participants must be between the ages of 6 and 22, have been diagnosed with Crohn's Disease in the last 90 days, and haven't received other similar treatments before. They should also have signs of active disease. If someone joins the trial, they can expect to receive infliximab and have their blood monitored closely to see how well the treatment is working. The trial is currently looking for participants, and anyone interested should talk to their doctor for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is \<18 years old
• • 2. Written informed assent from patient when age appropriate
• • 3. 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)
• • 4. ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab
• • 5. 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
• • 6. 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
• • 7. Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)
• Exclusion Criteria:
• • 1. Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
• • 2. Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol, or golimumab)
• • 3. Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days
• • 4. Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days
• • 5. Active perianal abscess (receiving oral antibiotics for \<7 days)
• • 6. Intestinal stricture (luminal narrowing with pre-stenotic dilation \>3 cm) and surgery planned in the next 90 days
• • 7. 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.
• • 8. Current hospitalization for complications of severe Crohn's disease
• • 9. Planned use of methotrexate or 6-mercaptopurine (azathioprine) during the induction (first 3 doses of infliximab) phase
• • 10. Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection (\>35 cm) or any CD surgery planned within the next 90 days
• • 11. History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritis
• • 12. Treatment with another investigational drug in the last four weeks
• • 13. History of malignancy (including lymphoma or leukemia)
• • 14. Currently receiving treatment for histoplasmosis
• • 15. 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
• • 16. Currently pregnant, breast feeding or plans to become pregnant in the next 1 year
• • 17. Inability or failure to provide informed assent/consent
• • 18. Any developmental disabilities that would impede providing assent/consent

Trial Officials