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

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease, with many of those being young children and adolescents. Physicians need better ways to inform decisions on treatment.

The main reason for this research study is to determine if a computer program that formulates a dose based on a patient's blood testing results can better achieve the optimal drug level as compared to standard dosing.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Crohn's and Colitis Foundation

Criteria

Inclusion 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

Exclusion Criteria:

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