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

NCT02522169 | Unknown

• 1 other identifier: 2014-000076-25
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pediatric Crohns Disease

Outcome Measures

Primary Outcomes (1)

• disease remission

  The trial's primary endpoint is the disease remission of pediatric patients receiving Infliximab therapy after an observation period of twelve month. This will be done by comapring the PCDAI of both groups after 12 month and the PCDAI perfomance in the respective group during the observation period. For monitoring the disease activity the PCDAI (Pediatric Crohn's Disease Activity Index) is deployed.

  12 months

Secondary Outcomes (3)

• Secondary endpoint is the rate of adverse reactions

  12 months

• Costs of treatment

  12 months

• 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

  12 months

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

The patients of the control group undergo Infliximab-maintenance according to the approved dosing scheme, initially with 5 mg/kg body weight Infliximab. Before each administration laboratory parameters will be controlled (Albumin, CrP, Calprotectin) and disease activity scores will be obtained (PCDAI / PUCAI). Infliximab trough levels will be assessed but not have any implication. In the presence of clinical signs of a disease exacerbation and after exclusion of other causes an adjustment of the dosage will follow for the next Infliximab-infusion: A) interval shortening, or B) Dose increase to 10 mg / kg body weight. With a clinical stable course of the disease without signs of deterioration, the dosage and the eight-week interval will be maintained.

Drug: Infliximab

Intervention Group

EXPERIMENTAL

Aiming to maintain the therapeutic window of Infliximab a de- or increase of the dose or infusion interval will be carried out for the following administration, provided the patient shows no signs of a clinical worsening. With good trough levels and clinically stable conditions the therapy will be continued without modification until next check-up. In the case of an eminent disease exacerbation Infliximab trough levels and the search for anti - Infliximab antibodies should guide further treatment decisions. With trough levels below the target range antibody testing should be performed.

Drug: Infliximab

Interventions

Infliximab DRUG

This is a randomized, prospective, parallel -controlled study, simple blinded and multicenter designed. Study centers are the Department of Child and Adolescent Medicine of the Ernst von Bergmann Hospital, Potsdam, and the Department of Child and Adolescent Medicine of Charité, Berlin. We estimate a sample size of 50 patients per center. Study inclusion begins with given consent of the patient and the legal guardian. Patients will be randomized in control- and intervention group separately for Cohn's disease. An equal age and gender distribution is targeted for both control and intervention group. Sub groups will be formed depending on the time span from completed Infliximab induction to study enrollment (group A\< 6month, group B \< 6 month). Observation period is one year.

Also known as: Remicade

Conventional treatment; Intervention Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Westbrandenburg GmbH: lead

MeSH Terms

Interventions

Infliximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Matthias Augustin Gonçalves

  Klinikum Westbrandenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Radke, Prof. Dr. med.

CONTACT

+49 331 241; mardke@klinikumwb.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2015
• First Posted: August 13, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 13, 2015

Record last verified: 2015-08