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Tumor Necrosis Factor (TNF) Blocker

Etanercept Dosing for Arthritis (PRECISE Trial)

Phase 1

Waitlist Available

Led By Stephen Balevic, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Active disease at screening, defined as a DAS28 > 3.2 in adults and JADAS27 > 3.8 in children

Diagnosis of Juvenile Idiopathic Arthritis (JIA) according to the International League Against Rheumatism Classification Criteria (children less than 16 years of age at screening)

Must not have

Personal history of ever having malignancy, lymphoproliferative disease, or demyelinating disease

Evidence of erosive osteoarthritis on plain films (if available at time of screening), or severe osteoarthritis (defined as any anticipated need for joint replacement within the next year) as judged by the primary rheumatologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand how well etanercept works in obese children and adults, and what the proper dosage should be.

Who is the study for?

This trial is for obese adults and children with active arthritis, specifically Rheumatoid Arthritis or Juvenile Idiopathic Arthritis. Participants must be starting etanercept treatment and have not used biologics recently. They can't join if they're pregnant, planning pregnancy, allergic to etanercept, have certain infections or severe blood, liver or kidney issues.

What is being tested?

The study aims to determine the optimal dosing of a drug called Etanercept in obese patients with arthritis. It will assess how different body weights affect the drug's effectiveness and metabolism in both adult and pediatric patients.

What are the potential side effects?

While specific side effects are not listed here, Etanercept generally may cause injection site reactions, increased risk of infections, allergic reactions, headache, nausea and potential autoimmune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disease activity score is high, indicating active disease.

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I have been diagnosed with Juvenile Idiopathic Arthritis and I am under 16.

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I am starting etanercept treatment as recommended by my rheumatologist.

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I have been diagnosed with Rheumatoid Arthritis and I am 16 or older.

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I am considered obese based on my BMI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer, lymph disease, or nerve damage disease before.

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I have severe osteoarthritis or need joint replacement within a year.

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My heart condition severely limits my physical activities.

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I have severe difficulty with daily activities due to my condition.

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I haven't had serious infections like hepatitis or pneumonia in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clearance (CL)

Volume of distribution (V)

Secondary study objectives

Median prediction error between observed and model predicted concentrations

mean change in DAS28/JADAS27

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Optimal dosingExperimental Treatment1 Intervention

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.

0 / 10Eligibility criteria met