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

University Hospital Basel

Status: Completed

Conditions: Rheumatic Diseases

Treatments: Other: pharmacokinetics (PK) measurement

Study type: Observational

Funder types: Other

Identifiers

NCT04042792

2019-00916 ks18Pfister2;

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

ADA for ≥12 weeks and concomitant MTX therapy

Description:

PiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous)

Treatment:

Other: pharmacokinetics (PK) measurement

ADA for ≥ 12 weeks without MTX

Description:

PiRD patients with ADA for ≥ 12 weeks without MTX ≥ 12 weeks (or never exposed to MTX)

Treatment:

Other: pharmacokinetics (PK) measurement