Precise Infliximab Exposure and Pharmacodynamic Control (NCT05660746)
Precise Infliximab Exposure and Pharmacodynamic Control to Achieve Deep Remission in Pediatric Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Children's Hospital of Los Angeles — Los Angeles, California
Age range: 6 Years to 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- Children's Hospital of Los Angeles — Los Angeles, California
- Lucile Packard Children's Hospital Stanford — Palo Alto, California
- Rady Children's Hospital San Diego — San Diego, California
- Nemours Children's Health System-Wilmington — Wilmington, Delaware
- Nemours Children's Health System-Jacksonville — Jacksonville, Florida
- Riley Hospital for Children — Indianapolis, Indiana
- Cincinnati Children's Hospital — Cincinnati, Ohio
- Cleveland Clinic Children's Hospital — Cleveland, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Specialty Group — Norfolk, Virginia
- Medical College of Wisconsin, Children's of Wisconsin — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (513) 636-4415
Email: phillip.minar@cchmc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn Disease
- Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease — Lutherville, Maryland
- Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial — New Haven, Connecticut
- A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease — Portland, Oregon
- Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) — Ottawa, Ontario
- A Long-term Extension Study of Ustekinumab in Pediatric Participants — Atlanta, Georgia
- Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease — Atlanta, Georgia
Explore by condition: All Crohn Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.