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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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24 August 2015 |
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Main ID: |
NCT02522169 |
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Date of registration:
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03/05/2015 |
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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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TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease
TOPIT |
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Scientific title:
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Verbessertes Therapiemanagement für pädiatrische CED-Patienten Mit Chronisch-entzündlicher Darmerkrankung: Eine Randomisierte Multizentrische Studie, Welche Die Effektivität Einer Talspiegel-gesteuerten Infliximab-Erhaltungsphase Mit Dem herkömmlichen Dosierungsregime Vergleicht Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Randomized Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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120 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02522169 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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N/A
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Contacts
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Name:
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Matthias Augustin Gonçalves |
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Address:
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Telephone:
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Email:
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Affiliation:
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Klinikum Westbrandenburg |
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Name:
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Michael Radke, Prof. Dr. med. |
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Address:
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Telephone:
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+49 331 241 |
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Email:
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mardke@klinikumwb.de |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pediatric patients of both sexes with Cohn's disease
- Assured diagnosis of Cohn's disease according to the Porto criteria
- Regular attendance of gastroenteric consultations at one of the study centers
- Minimum patients age of 6 years, maximum age of 16 years
- Infliximab therapy with permitted / without co- medication
- Completed induction with Infliximab in accordance to the approved conventional
scheme with primary therapy response
- Written consent of the patient and the legal guardian
Exclusion Criteria:
- No consent of the patient and / or legal guardian
- Serious side effects under Infliximab therapy in the past
- Primary non-responder to Infliximab after first three cycles
Age minimum:
6 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pediatric Crohns Disease
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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disease remission
[Time Frame: 12 months]
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Secondary Outcome(s)
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The number of patients with a reset of therapy due to secondary loss of response, e.g. to a differend biological therapy, is the focus of ths secondary outcome
[Time Frame: 12 months]
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Secondary endpoint is the rate of adverse reactions
[Time Frame: 12 months]
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Costs of treatment
[Time Frame: 12 months]
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Secondary ID(s)
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2014-000076-25
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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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