Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
Completed
- Conditions
- Rheumatic Diseases
- Registration Number
- NCT04042792
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ADA concentration (in mg/L) during regular clinical follow up 3-6 months after inclusion ADA concentration (in mg/L)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University Children's Hospital Tubingen
🇩🇪Tübingen, Germany
University of Basel Children's Hospital
🇨🇭Basel, Switzerland
University Children's Hospital Tubingen🇩🇪Tübingen, Germany