Actively Recruiting
Precise Infliximab Exposure and Pharmacodynamic Control
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-05-05
180
Participants Needed
11
Research Sites
195 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Precise Infliximab Exposure and Pharmacodynamic Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent from patients 18 years or older, or from parent/legal guardian if younger than 18
- Written informed assent from patient when appropriate
- Diagnosis of Crohn's disease within the last 90 days
- Age between 6 and 22 years, anti-TNF naive, and starting infliximab treatment
- Clinical activity and luminal inflammation defined by PCDAI 10 (<18 years) or CDAI 150 ( 18 years) within 60 days before starting infliximab
- SES-CD >6 or SES-CD >3 for isolated ileal disease, or large intestinal ulcerations within 60 days, or fecal calprotectin >250 bcg/g within 75 days before screening
- C-reactive protein >1.0 mg/dL in last 30 days and/or fecal calprotectin >250 bcg/g within 75 days before screening
- Negative tuberculosis interferon-gamma release test
- Negative urine pregnancy test for females if menstruation has started
You will not qualify if you...
- Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
- Prior use of anti-TNF therapy such as infliximab, adalimumab, certolizumab pegol, or golimumab
- Internal penetrating fistulae in the last 180 days
- Intra-abdominal abscess, phlegmon, or inflammatory mass in last 180 days
- Active perianal abscess receiving oral antibiotics for less than 7 days
- Intestinal stricture with surgery planned in next 90 days
- Positive test for Clostridium difficile toxin or other intestinal pathogens within 14 days unless repeat negative and no signs of infection
- Current hospitalization for severe Crohn's disease complications
- Planned use of methotrexate or 6-mercaptopurine during induction phase
- Current ileostomy, colostomy, ileoanal pouch, previous extensive small bowel resection over 35 cm, or planned Crohn's surgery within 90 days
- History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, or juvenile idiopathic arthritis
- Treatment with another investigational drug in last 4 weeks
- History of malignancy including lymphoma or leukemia
- Currently receiving treatment for histoplasmosis
- History of tuberculosis, HIV, immunodeficiency syndrome, central nervous system demyelinating disease, heart failure, or recent intravenous antibiotics
- Currently pregnant, breastfeeding, or planning pregnancy within next year
- Unable or failed to provide informed assent or consent
- Developmental disabilities preventing assent or consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
3
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Actively Recruiting
4
Nemours Children's Health System-Wilmington
Wilmington, Delaware, United States, 19803
Actively Recruiting
5
Nemours Children's Health System-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
6
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
8
Cleveland Clinic Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
9
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
10
Children's Specialty Group
Norfolk, Virginia, United States, 23507
Actively Recruiting
11
Medical College of Wisconsin, Children's of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
P
Phillip Minar, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here