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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

120 participantsStarted 2015-09

Plain-language summary

This clinical trail intends to evaluate interventions based on the Infliximab trough levels for an individualized therapy adaption for pediatric IBD-patients undergoing anti-TNF-alpha-therapy. Main aim of the individualized strategy is to attain and maintain early disease control in order to keep as many patients as possible in disease remission, and to avoid primary and secondary therapy failure.

Who can participate

Age range6 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

disease remission

Timeframe: 12 months

Trial details

NCT IDNCT02522169

SponsorKlinikum Westbrandenburg GmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

Contact for this trial

Michael Radke, Prof. Dr. med.

+49 331 241 mardke@klinikumwb.de

View on ClinicalTrials.gov More Pediatric Crohns Disease trials