NCT04585711

Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Juvenile Idiopathic Arthritis
• Rheumatoid Arthritis
• Obesity

Interventions

Type	Name	Description
DRUG	Etanercept Optimal dosing	Patients will receive Etanercept on an optimal dose interval over a 6-week period based on a PK/PD model.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2020-10-14
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States