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Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis

NCT04585711 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Etanercept Optimal dosing

Patients will receive Etanercept on an optimal dose interval over a 6-week period based on a PK/PD model.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Stephen Balevic, MD · Duke Clinical Research Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585711 on ClinicalTrials.gov