RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-01

Study Completion:2024-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04974099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Phillip Minar, MD, MS

CONTACT

513-636-4415

phillip.minar@cchmc.org

Principal Investigator

Phillip Minar, MD, MS

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Phillip Minar, MD, MS, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-01

Study Completion Date2024-08-01

Study Record Updates

Study Start Date2021-10-01

Study Completion Date2024-08-01

Terms related to this study

Additional Relevant MeSH Terms

Crohn Disease