Weighty questions: how obesity affects arthritis drug dosing
NCT ID NCT04585711
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study aimed to understand how body weight influences the way etanercept works in obese adults and children with arthritis. Researchers planned to use blood samples and computer models to find the best dose for heavier patients. However, the study was withdrawn before enrolling any participants, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Etanercept
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Diagnosis of Rheumatoid Arthritis (RA) according to the 2010 American College of Rheumatology Classification Criteria (patients greater than or equal to 16 years of age at screening) * Diagnosis of Juvenile Idiopathic Arthritis (JIA) according to the International League Against Rheumatism Classification Criteria (children less than 16 years of age at screening) * Initiating treatment with etanercept as standard of care by a patient's primary rheumatologist * Obese at baseline, defined as a body mass index (BMI) greater than or equal to 30 kg/m2 in subjects greater than or equal to 18 years of age, and a BMI greater than or equal to 95th percentile for age and sex in subjects less than18 years of age * Active disease at screening, defined as a DAS28 \> 3.2 in adults and JADAS27 \> 3.8 in children * Patients using oral corticosteroids (\<10 mg) or DMARDs must be on a stable dose for at least 4 weeks prior to screening Exclusion Criteria * Receipt of any investigational medical product within the past 12 months * Positive urine pregnancy test at screening or planned pregnancy during the study period * Prior exposure to etanercept or any other biologic agent within 5 drug half-lives * Contraindication to etanercept (e.g., allergy, current or chronic infection \[positive tuberculosis screening test, positive hepatitis B surface antigen, positive hepatitis C antibody\]) * Personal history of ever having malignancy, lymphoproliferative disease, or demyelinating disease * Screening safety labs with a hemoglobin of ≤ 9 g/dL, white blood cell count \<3.0x109L, platelets \<125,000 x109L, AST/ALT more than 2x the upper limit of normal, or creatinine \> 2 mg/dL for adults and \>1 mg/dL for children * 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 * History of any opportunistic infections, or recent severe infection in the 3 months prior to screening (e.g., hepatitis, pneumonia, pyelonephritis, bacteremia) * Heart failure with NYHA classification 3 or more * Severe functional impairment status, defined as HAQ \>2 and CHAQ \>1.75
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Duke University Medical Center
Durham, North Carolina, 27705, United States
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