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Weighty questions: how obesity affects arthritis drug dosing

NCT ID NCT04585711

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the study was withdrawn before enrolling any participants, so no results are available.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

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

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

2 to 65 years

Sex

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

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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