Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate

University Hospital, Basel, Switzerland28 enrolled

Overview

This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to assess peak and trough ADA concentrations in ADA naïve patients after first ADA administration with and without MTX (pre-phase).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatic Diseases

Interventions

pharmacokinetics (PK) measurementOTHER

two ADA-PK samples will be collected during routine rheumatology visits in case of medical indicated blood draw (1 trough PK sample and 1 random PK sample per subject)

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of a juvenile idiopathic Arthritis (JIA), uveitis or chronic recurrent multifocal osteomyelitis (CRMO) * Medical indication for initiation of ADA treatment or established ADA therapy for ≥ 12 weeks * Exclusion of chronic infections * No parallel treatment with other biologic medications * Available patient history since ADA start * No pregnancy * Ability to comply with the entire study protocol * Willingness to participate with signed informed consent Exclusion Criteria: * Other rheumatic inflammatory diseases * Age \< 2 years or \>18 years * PiRD patients and parents with cognitive impairments preventing to understand study requirements * Additional severe chronic disease (kidney failure, liver insufficiency), malignancies or prior chemotherapy

Locations (2)

University Children's Hospital Tubingen

Tübingen, Germany

University of Basel Children's Hospital

Basel, Switzerland

Outcomes

Primary Outcomes

ADA concentration (in mg/L)

Time frame: at study inclusion

ADA concentration (in mg/L)

Time frame: during regular clinical follow up 3-6 months after inclusion

Data from ClinicalTrials.gov

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