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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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4 October 2021 |
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Main ID: |
NCT03209232 |
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Date of registration:
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01/07/2017 |
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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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Infliximab Accelerated Induction in Moderate to Severe Pediatric UC
INDUCE |
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Scientific title:
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Infliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) Trial |
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Date of first enrolment:
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April 16, 2018 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03209232 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Amit Assa, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Schneider Children's Medical Center, Israel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Ulcerative colitis
2. PUCAI=35
3. Age: 6 - 17 years (inclusive)
4. Planned to initiate IFX therapy.
5. Naïve to biologics
6. Informed consent
7. Neg. PPD-Test, negative HBV- S Ag
8. Negative stool culture, parasites and clostridium toxin
Exclusion Criteria:
1. Pregnancy.
2. Acute severe colitis.
3. Renal Failure.
4. Toxic megacolon.
5. Patients whose disease is confined to the rectum (i.e. proctitis).
6. Prior treatment with infliximab or adalimumab.
7. Previous malignancy.
8. Sepsis or active bacterial infection.
9. Known immune deficiency.
10. Positive Hepatitis B surface antigen or evidence for TB.
11. IBD unclassified.
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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Clinical remission on infliximab
[Time Frame: 20 weeks]
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Secondary Outcome(s)
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Colectomy free rate
[Time Frame: 52 weeks]
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Calprotectin level
[Time Frame: 20 weeks]
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Clinical remission on infliximab
[Time Frame: 52 weeks]
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Adverse events
[Time Frame: 20 weeks]
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Drug levels prior to last study infusion
[Time Frame: 14 weeks]
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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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