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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

PRECISE Trial 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.Check my eligibility

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.See study design

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.

PRECISE Trial 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.

PRECISE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clearance (CL)

Volume of distribution (V)

Secondary outcome measures

Median prediction error between observed and model predicted concentrations

mean change in DAS28/JADAS27

PRECISE 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

483 Previous Clinical Trials

1,086,910 Total Patients Enrolled

44 Trials studying Rheumatoid Arthritis

560,977 Patients Enrolled for Rheumatoid Arthritis

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,039 Total Patients Enrolled

11 Trials studying Rheumatoid Arthritis

2,124 Patients Enrolled for Rheumatoid Arthritis

Stephen Balevic, MDPrincipal InvestigatorDuke Clinical Research Institute

2 Previous Clinical Trials

321 Total Patients Enrolled

Media Library

Etanercept (Tumor Necrosis Factor (TNF) Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04585711 — Phase 1

Rheumatoid Arthritis Research Study Groups: Optimal dosing

Rheumatoid Arthritis Clinical Trial 2023: Etanercept Highlights & Side Effects. Trial Name: NCT04585711 — Phase 1

Etanercept (Tumor Necrosis Factor (TNF) Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04585711 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does age disqualify potential participants from this experiment?

"According to the study's eligibility requirements, patients that fall between the ages of 2 and 65 may apply to participate. There are currently 263 studies underway for patients that are younger than 18 and 984 for patients that are older than 65."

Answered by AI

What are the primary conditions that this medication is used to manage?

"This therapy is commonly used to ameliorate moderate to severe symptoms, but it can also be helpful in the management of other diseases like rheumatoid arthritis and ankylosing spondylitis."

Answered by AI

Has this therapy received regulatory approval from the FDA?

"While Phase 1 trials are limited in the amount of safety data they can provide, this particular treatment scored a 1."

Answered by AI

Might I be a good candidate for this clinical research project?

"This clinical trial is looking for 30 participants that suffer from rheumatoid arthritis, are aged 2-65, and meet the following criteria: A diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology Classification Criteria (patients 16 years of age or older at screening), A diagnosis of Juvenile Idiopathic Arthritis according to the International League Against Rheumatism Classification Criteria (children younger than 16 years of age at screening), Etanercept must be used as a standard of care treatment by the patient's primary rheumatologist, Obesity at baseline (defined"

Answered by AI

Are there any other similar research projects that have been conducted with this treatment?

"As of now, there are 35 ongoing trials investigating this medication with 10 of them being in the final stage of research. The majority of these trials are based in Xi'an, Shaanxi; however, there are a total of 662 research sites for this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis

2024. "Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04585711.

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