Status:
COMPLETED
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Rheumatic Diseases
Eligibility:
All Genders
2-18 years
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 methotrex...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 26 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 28 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04042792
Start Date
September 26 2019
End Date
June 28 2021
Last Update
December 1 2021
Active Locations (2)
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1
University Children's Hospital Tubingen
Tübingen, Germany, 72076
2
University of Basel Children's Hospital
Basel, Switzerland, 4031