The purpose of this study is to learn more about how adult and children's bodies use etanercept and how bodyweight influences how well etanercept works. This study will help us understand the proper dose of etanercept in obese children and adults.
PRECISE is an open-label, single arm, single-center site study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of dosing interval-optimized etanercept in obese patients with Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA). Approximately 30 patients with JIA or RA who are starting etanercept standard-of-care will take part in the study. Eligible patients will have blood collections before and after starting the biologic of interest to assess PK and disease activity. Five (5) blood samples will be collected through a combination of clinic and home visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Patients will receive Etanercept on an optimal dose interval over a 6-week period based on a PK/PD model.
Duke University Medical Center
Durham, North Carolina, United States
Clearance (CL)
Clearance at steady state as measured by PK sampling
Time frame: 6 weeks
Volume of distribution (V)
Volume of distribution at steady state as measured by PK sampling
Time frame: 6 weeks
Median prediction error between observed and model predicted concentrations
We will use PK/PD models to simulate drug concentration for each individual subject. We measure the error between simulated and observed plasma concentrations.
Time frame: 6 weeks
mean change in DAS28/JADAS27
We will score disease activity using the DAS28 (RA) or JADAS27 (JIA) at baseline and 6 week follow up. We will measure the change in score over 6 weeks.
Time frame: Baseline, 6 weeks
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