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Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis (PRECISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585711
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : September 27, 2021
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Duke University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Rheumatoid Arthritis Obesity Drug: Etanercept Optimal dosing Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Etanercept

Arms and Interventions
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Arm Intervention/treatment
Optimal dosing
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.
 Drug: Etanercept Optimal dosing
Patients will receive Etanercept on an optimal dose interval over a 6-week period based on a PK/PD model.


Outcome Measures
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Primary Outcome Measures :
  1. Clearance (CL) [ Time Frame: 6 weeks ]
    Clearance at steady state as measured by PK sampling

  2. Volume of distribution (V) [ Time Frame: 6 weeks ]
    Volume of distribution at steady state as measured by PK sampling


Secondary Outcome Measures :
  1. Median prediction error between observed and model predicted concentrations [ Time Frame: 6 weeks ]
    We will use PK/PD models to simulate drug concentration for each individual subject. We measure the error between simulated and observed plasma concentrations.

  2. mean change in DAS28/JADAS27 [ Time Frame: Baseline, 6 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585711


Contacts
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Contact: Balevic Stephen, MD 919-668-4544 Stephen.balevic@duke.edu
Contact: Cobbaert Marjan, MPH

Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Contact: Edna Scarlett         
Sponsors and Collaborators
Duke University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Stephen Balevic, MD Duke Clinical Research Institute
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04585711    
Other Study ID Numbers: Pro00105975
1K23AR075874-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
Etanercept
Pharmacokinetics
Pharmacodynamics
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors