Precise Infliximab Exposure and Pharmacodynamic Control (NCT05660746) | Clinical Trial Compass
RecruitingPhase 2/3
Precise Infliximab Exposure and Pharmacodynamic Control
United States180 participantsStarted 2023-07-01
Plain-language 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
Age range6 Years – 22 Years
SexALL
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Inclusion criteria
✓. 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)
✓. 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)
Exclusion criteria
✕. Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
✕
What they're measuring
1
Rate of Deep Remission
Timeframe: Week 52
Trial details
NCT IDNCT05660746
SponsorChildren's Hospital Medical Center, Cincinnati
. 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