Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis

Phase 1

Not yet recruiting

• Conditions: Juvenile Idiopathic Arthritis; Obesity; Rheumatoid Arthritis
• Interventions: Drug: Etanercept Optimal dosing

• Registration Number: NCT04585711
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Study Start: 2025-07-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optimal dosing	Etanercept Optimal dosing	Obese children (≥ 2 year old) and adults with juvenile idiopathic arthritis (JIA) or Rheumatoid Arthritis (RA) who are starting etanercept as part of their routine medical care.

Primary Outcome Measures

Name	Time	Method
Volume of distribution (V)	6 weeks	Volume of distribution at steady state as measured by PK sampling
Clearance (CL)	6 weeks	Clearance at steady state as measured by PK sampling

Secondary Outcome Measures

Name	Time	Method
Median prediction error between observed and model predicted concentrations	6 weeks	We will use PK/PD models to simulate drug concentration for each individual subject. We measure the error between simulated and observed plasma concentrations.
mean change in DAS28/JADAS27	Baseline, 6 weeks	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States