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NCT04042792 Clinical Trial

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

Rheumatic Diseases Clinical Trial

— ADA in PiRD  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04042792
Other study ID # 2019-00916; ks18Pfister2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 26, 2019
Est. completion date June 28, 2021

Study information
Verified date November 2021
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date June 28, 2021
Est. primary completion date June 28, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• pharmacokinetics (PK) measurement
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)

Locations
Country Name City State
Germany University Children's Hospital Tubingen Tübingen
Switzerland University of Basel Children's Hospital Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary ADA concentration (in mg/L) ADA concentration (in mg/L) at study inclusion
Primary ADA concentration (in mg/L) ADA concentration (in mg/L) during regular clinical follow up 3-6 months after inclusion
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