A Study to Perform Synovial Biopsies on Patients with Rheumatoid Arthritis

Overview

Información sobre este estudio

The purpose of this study is to get synovial tissue from patients with rheumatoid arthritis by minimally invasive ultrasound guided biopsy, for the purpose of identifying the processes that are responsible for the cause of the disease. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Have a diagnosis of rheumatoid arthritis as defined by either the 1987 ARA or 2010 ACR/EULAR criteria 
    • data for both criteria will be recorded
  • Must have been 18 years of age or older at the time of diagnosis of RA
  • At least one joint swollen and thought to be due to active RA
    • Joint should be amenable to minimally invasive ultrasound guided synovial tissue biopsy (MIUGSTB) including elbow, wrist, MCP, PIP, knee, ankle, or shoulder 
  • Screening laboratory tests must meet the following criteria
    • Hemoglobin ≥ 9 g/dL
    • Platelets ≥ 100 x 109 cells/L
  • Able to adhere to the study visit schedule, understand and comply with other protocol requirements
  • Capable of giving informed consent, which will be obtained prior to any screening procedures
  • Control subjects must be arthritis-free
  • Surgical osteoarthritis patients must have a clinical diagnosis of osteoarthritis and are undergoing a clinically directed surgical procedure
  • Surgical rehumatoid arthritis patients must have a diagnosis of RA (as defined by the either 1987 ARA or 2010 ACR/EULAR criteria – data for both criteria will be recorded ) and are undergoing a clinically directed surgical procedure
  • All subjects must have given signed, informed consent prior to registration on study

Exclusion Criteria

  • Pregnant or lactating women
  • Active infections such as hepatitis, pneumonia, pyelonephritis or chronic skin infections
  • Current signs or symptoms of uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease
  • History of bleeding disorder
  • History of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Documented diagnosis of SLE or seronegative spondyloarthropathy
  • Soft tissue, or intra-muscular corticosteroid injections during the 4 weeks prior to screening
  • Corticosteroid injection into joint to be biopsied (within 8 weeks)
  • Previous arthroplasty on the target joint
  • Current use of warfarin, clopidogrel or other anticoagulant
  • Prednisone or equivalent > 10 mg daily
  • Exclusion criteria are the same for controls

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Eric Matteson, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20272687

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