Personalized infliximab dosing for Crohn's disease treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a computer program that calculates individualized infliximab doses based on patients' blood test results, compared to standard dosing methods. It is an open-label, cluster randomized trial focusing on achieving deep remission in patients with Crohn's disease. The study will monitor patients receiving precision dosing during both the induction and maintenance phases of treatment to determine if this approach leads to better outcomes than conventional care.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital of Los Angeles
  Los Angeles, California, United States Recruiting
• Lucile Packard Children's Hospital Stanford
  Palo Alto, California, United States Recruiting
• Rady Children's Hospital San Diego
  San Diego, California, United States Recruiting
• Nemours Children's Health System-Wilmington
  Wilmington, Delaware, United States Recruiting
• Nemours Children's Health System-Jacksonville
  Jacksonville, Florida, United States Recruiting
• Riley Hospital for Children
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Phillip Minar, MD,MS — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Phillip Minar, MD, MS
• Email: phillip.minar@cchmc.org
• Phone: 513-636-4415

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry of Infliximab for Children with Crohn's Disease in China

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• Microencapsulated Propionate vs Butyrate for Crohn's Disease in Remission

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.