Modulation of infliximab therapy based on blood drug levels in pediatric inflammatory bowel disease.

Phase 1

• Conditions: Pediatric Inflammatory Bowel Disease; MedDRA version: 20.0Level: LLTClassification code 10021184Term: IBDSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-003220-32-IT
• Lead Sponsor: IRCCS MATERNO INFANTILE BURLO GAROFOLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-22
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Inclusion criteria are:
1.Anti-TNF naïve children and adolescents, 6-17 years, with a diagnosis of IBD confirmed by a prior endoscopic biopsy that is consistent with the diagnosis
2.Indication to start anti-TNF therapy in accordance with current guidelines for the treatment of pediatric IBD,
3.Active inflammation supported by CRP > 5mg/L and /or FC > 150 µg/g before the 1st IFX dose
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Consent withdrawal,
2.Stenosing or penetrating disease requiring surgery, abdominal abscess, symptomatic stricture,
3.Abdominal surgery within the previous 6 months,
4.Acute severe UC attack defined by a PUCAI score > 65,
5.Infective contraindication to IFX treatment including positive tuberculin skin test or Quantiferon-TB test, recent opportunistic infection, infection with hepatitis B (HBV), C (HCV), human immunodeficiency virus (HIV),
6.Previous exposure to anti-TNF;
7.Exposure to concomitant prohibited medications including other biologics (including but not limited to ustekinumab, vedolizumab, abatacept, anakinra..), thalidomide, investigational drugs
8.Pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified