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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 January 2025 |
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Main ID: |
NCT04974099 |
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Date of registration:
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29/06/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease
REMODEL |
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Scientific title:
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Personalized Infliximab Induction Strategy With Model-informed Dosing in Patients With Crohn's Disease |
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Date of first enrolment:
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October 1, 2021 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04974099 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Phillip Minar, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
22 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Device: RoadMAB
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Drug: Precision dosing with a dashboard
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Primary Outcome(s)
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Obtain safety data for optimal dosing strategy and sample size estimation
[Time Frame: 2 years]
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Completion feasibility
[Time Frame: 2 years]
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Rate of patient adherence to stool and blood sample collections
[Time Frame: 2 years]
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RoadMAB Efficacy
[Time Frame: 2 years]
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Enrollment feasibility
[Time Frame: 2 years]
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RoadMAB Usability
[Time Frame: 2 years]
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Secondary Outcome(s)
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Infus4 (Visit 5) and Infus6 (Visit 7): Fecal Biochemical Response
[Time Frame: 2 years]
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Infus6 (Visit 7): Rate of transmural ileal
[Time Frame: 2 years]
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Sustained Remission
[Time Frame: 2 years]
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Evaluate accuracy of infliximab concentration targets - Incidence
[Time Frame: 2 years]
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Evaluate accuracy of infliximab concentration targets - Median difference infus2
[Time Frame: 2 years]
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Infus6 (Visit 7): Rate of total bowel healing
[Time Frame: 2 years]
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Evaluate accuracy of infliximab concentration targets - Median difference infus3
[Time Frame: 2 years]
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Infus6 (Visit 7): Rate of colonic healing
[Time Frame: 2 years]
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Infus4 (Visit 5) and Infus6 (Visit 7): Fecal Biochemical Remission
[Time Frame: 2 years]
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Evaluate accuracy of infliximab concentration targets - Maintenance
[Time Frame: 2 years]
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Evaluate accuracy of infliximab concentration targets
[Time Frame: 2 years]
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Infus4 (Visit 5) and infus6 (Visit 7): Clinical Response
[Time Frame: 2 years]
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Infus4 (Visit 5) and infus6 (Visit 7): Clinical Remission
[Time Frame: 2 years]
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Secondary ID(s)
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2020-0282
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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