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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Klinikum Westbrandenburg GmbH
• Treatments: Infliximab

Criteria

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