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

Study Overview
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Brief Summary
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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).

Official Title
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Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)

Conditions
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Rheumatic Diseases

Intervention / Treatment
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* Other: pharmacokinetics (PK) measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADA for ≥12 weeks and concomitant MTX therapy<br>PiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous) | Other: pharmacokinetics (PK) measurement<br>* 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)<br>|
| ADA for ≥ 12 weeks without MTX<br>PiRD patients with ADA for ≥ 12 weeks without MTX ≥ 12 weeks (or never exposed to MTX) | Other: pharmacokinetics (PK) measurement<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADA concentration (in mg/L) | ADA concentration (in mg/L) | at study inclusion | 
| ADA concentration (in mg/L) | ADA concentration (in mg/L) | during regular clinical follow up 3-6 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, pharmacodynamics, Adalimumab, methotrexate, drug-drug interaction, trough ADA concentration, peak ADA concentration, Pediatric inflammatory rheumatic diseases