Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease

Eligibility Criteria

• 1. Written informed consent form from the patient (≥18 years old) or from parent/legal guardian if patient is \<18 years old.
• 2. Written informed assent form from patient ≥11 years old.
• 3. Age criteria: ≥6 years to ≤22 years of age.
• 4. Diagnosis of Crohn's Disease
• 5. Starting infliximab (or biosimilar)
• 6. Anti-TNF naïve (never received infliximab, adalimumab, golimumab, certolizumab or anti-TNF biosimilar)
• 7. Fecal calprotectin \>250 µg/g or fecal lactoferrin \>10 µg/g (up to 6 weeks prior to starting infliximab) or endoscopic evidence of active Crohn's disease (up to 90 days prior to starting infliximab)
• 8. wPCDAI \>12.5 (up to 6 weeks) prior to the first infliximab infusion
• 9. Negative urine pregnancy test for ALL female subjects
• 10. Negative TB (tuberculosis) blood test
• 1. Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified
• 2. Prior treatment with infliximab, adalimumab, certolizumab or golimumab (or anti-TNF biosimilar)
• 3. Active or prior evidence in past 12 months of internal (abdominal/pelvic) penetrating fistula(e)
• 4. Active intestinal stricture (luminal narrowing with pre-stenotic dilation \>3mm), intra-abdominal abscess or perianal abscess
• 5. Active Clostridium difficile infection or other known bacterial/viral gastroenteritis in last two weeks
• 6. Current ileostomy, colostomy, ileoanal pouch, and/or previous extensive small bowel resection leading to short bowel syndrome
• 7. History of autoimmune disease (including autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)
• 8. Treatment with another investigational drug within four weeks.
• 9. Treatment with intravenous antibiotics within four weeks.
• 10. Planned continuation of 6-mercaptopurine or azathioprine (Imuran) during study.
• 11. Planned continuation of methotrexate during study.
• 12. Treatment with intravenous corticosteroids within two weeks.
• 13. Currently pregnant, breast feeding or plans in next 12 months to become pregnant
• 14. Inability or failure to provide informed assent/consent