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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases

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