Juvenile Idiopathic ArthritisPhase 1PRECISENCT04585711
Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis
A Phase 1 study testing Etanercept Optimal dosing in people with Juvenile Idiopathic Arthritis and Rheumatoid Arthritis, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Obesity
- What is being tested?
- Etanercept Optimal dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 28 Feb 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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.
Read the detailed description
PRECISE is an open-label, single arm, single-center site study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of dosing interval-optimized etanercept in obese patients with Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA). Approximately 30 patients with JIA or RA who are starting etanercept standard-of-care will take part in the study.
Eligible patients will have blood collections before and after starting the biologic of interest to assess PK and disease activity. Five (5) blood samples will be collected through a combination of clinic and home visits.
- Conditions
- Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Obesity
- Being tested
- Etanercept Optimal dosing
- Keywords
- Etanercept, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Arthritis, Juvenile, Arthritis, Rheumatoid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etanercept Optimal dosingDrug
Patients will receive Etanercept on an optimal dose interval over a 6-week period based on a PK/PD model.
| Study group | Role | What they receive |
|---|---|---|
| Optimal dosing | Other | 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. Receives: Drug: Etanercept Optimal dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance (CL)
Clearance at steady state as measured by PK sampling
Measured: 6 weeks
Volume of distribution (V)
Volume of distribution at steady state as measured by PK sampling
Measured: 6 weeks
Secondary outcomes (2)
Median prediction error between observed and model predicted concentrations
We will use PK/PD models to simulate drug concentration for each individual subject. We measure the error between simulated and observed plasma concentrations.
Measured: 6 weeks
mean change in DAS28/JADAS27
We will score disease activity using the DAS28 (RA) or JADAS27 (JIA) at baseline and 6 week follow up. We will measure the change in score over 6 weeks.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jul 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Why it stopped: Funding expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Stephen Balevic, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585711
- Sponsor's protocol ID
- Pro00105975
- Other IDs
- 1K23AR075874-01A1
- Acronym
- PRECISE
- Status last verified
- Sep 2025
- First submitted
- 7 Oct 2020
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis
- ClinicalTrials.gov ID
- NCT04585711
- Acronym / sponsor ID
- PRECISE / Pro00105975
- Conditions
- Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Obesity
- Keywords
- Etanercept, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding expired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRECISE is an open-label, single arm, single-center site study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of dosing interval-optimized etanercept in obese patients with Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA). Approximately 30 patients with JIA or RA who are starting etanercept standard-of-care will take part in the study.
Eligible patients will have blood collections before and after starting the biologic of interest to assess PK and disease activity. Five (5) blood samples will be collected through a combination of clinic and home visits.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimal dosing | Other | Drug: Etanercept Optimal dosingObese 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. |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etanercept Optimal dosingPatients will receive Etanercept on an optimal dose interval over a 6-week period based on a PK/PD model. | Drug | Optimal dosing |
Primary outcome
Clearance (CL)
Time frame: 6 weeks
Clearance at steady state as measured by PK sampling
Volume of distribution (V)
Time frame: 6 weeks
Volume of distribution at steady state as measured by PK sampling
2 secondary outcomes
Median prediction error between observed and model predicted concentrations
Time frame: 6 weeks
mean change in DAS28/JADAS27
Time frame: Baseline, 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Juvenile Idiopathic Arthritis
RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Recruiting
The Use of Infrared Cameras for Detecting Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis, Infrared Thermography
Not yet recruitingPhase 4
Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingObservational study
Tofacitinib in Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Balevic, MD principal investigator
Duke Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etanercept Optimal dosing in people with Juvenile Idiopathic Arthritis and Rheumatoid Arthritis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance (CL) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.