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

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

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).

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