Precise Infliximab Exposure and Pharmacodynamic Control
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 re
| Condition(s) | Crohn Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | 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 la |
| Ages | 6 Years to 22 Years |
| Sex | All |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Locations | Los Angeles, California, United States; Palo Alto, California, United States; San Diego, California, United States; Wilmington, Delaware, United States; Jacksonville, Florida, United States; Indianapolis, Indiana, United States (+5 more sites) |
| Start date | 2023-07-01 |
| NCT ID | NCT05660746 |
| Official listing | https://clinicaltrials.gov/study/NCT05660746 |