Shared Biorepository for the Investigation of Inflammatory Arthritis at Mayo Clinic and University of Massachusetts

Overview

Información sobre este estudio

The purpose of this study is to establish a comparator cohort of patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other spondyloarthropathies. We will collect demographic information, historical information about diagnosis and past treatment, and clinical, radiographic, and laboratory data on each patient using standardized data collection forms.  We will also collect blood and synovial tissue samples from each patient.  This will provide data and material for clinical and translational research to address questions related to the fundamental differences between the spondyloarthropathies and inflammatory arthritis relating to the response of bone to chronic inflammation.  We intend to enroll sequential patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other spondyloarthropathies who present to the Rheumatology Division at Mayo Clinic Rochester. 

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:

  • Rheumatoid Arthritis
    • Individuals must have at least one joint with definite clinical synovitis (swelling) that is not better explained by another disease.  Scores of categories A – D below will be added; a score of ≥ 6/10 is needed for inclusion in this study.
      • Joint Involvement
        • 1 large joint, 0 score
        • 2 – 10 large joints, 1 score
        • 1 – 3 small joints (with or without involvement of large joints), 2 score
        • 4 – 10 small joints (with or without involvement of large joints), 3 score
        • > 10 joints (at least 1 small joint), 5 score
      • Serology (at least one test result is needed)
        • Negative RF and Negative ACPA, 0 score
        • Low-positive RF or low-positive ACPA, 2 score
        • High-positive RF or high-positive ACPA, 3 score
      • Acute-phase reactants (at least one test result is needed)
        • Normal CRF and normal ESR, 0 score
        • Abnormal CRF or abnormal ESR, 1 score
      • Duration of symptoms
        • < 6 weeks, 0 score
        • ≥ 6 weeks, 1 score
  • Psoriatic Arthritis
    • Individuals must have inflammatory articular disease (joint, spine, entheseal) with at least 3 of the following 5 points:
      • Evidence of psoriasis (one of a, b, c)
        • a. Current psoriasis: psoriatic skin or scalp disease currently present, as judged by a rheumatologist or a dermatologist
        • b. Personal history of psoriasis: a history of psoriasis obtained from patient or family physician, dermatologist, rheumatologist or other qualified health care professional
        • c. Family history of psoriasis: a history of psoriasis in a first or second degree relative by patient report
      • Psoriatic nail dystrophy
        • Typical psoriatic nail dystrophy, including onycholysis, pitting and hyperkeratosis observed on current physical exam
      • Negative test result for Rheumatoid Factor
        • Determined by any method except latex but preferably by ELISA or nephelometry, according to the local laboratory reference range
      • Dactylitis
        • Current (swelling of an entire digit)
        • History (a history of dactylitis recorded by a rheumatologist)
      • Radiological Evidence of juxta-articular new bone formation
        • Ill-defined ossification near joint margins - extending osteophyte formation - on plain X-ray films of hand or foot
    • Axial Spondyloarthritis
      • Individuals with all of the following 3 points:
        • Back pain
          • Lasting more than 3 months
          • Age of onset less than 45 years
        • One of a, b, c
          • a. Sacroiliitis on imaging (MRI or X-ray) plus one spondyloarthropathy feature listed below (in box c)
          • b. Positive testing for HLA-B27 plus two spondyloarthropathy features listed below (in box c)
          • c. Spondyloarthropathy features:
            • inflammatory back pain
            • Arthritis, enthesitis (heel)
            • Uveitis
            • Dactylitis
            • Psoriasis
            • Crohn's/colitis 
            • Good response to NSAIDS 
            • Family history for spondyloarthritis 
            • HLA-B27 
            • Elevated CRP 
            • Sacroiliitis on imaging
    • Peripheral Spondyloarthritis
      • Individuals that have been diagnosed with Arthritis, Enthesitis or Dactylitis AND one of criteria below:
        • At least one of the following - psoriasis, inflammatory bowel disease, preceding infection, HLA-B27, uveitis, or sacroiliitis on imaging (radiographs or MRI)
        • At least two of the following - arthritis, enthesitis, dactylitis, inflammatory back pain in the past, or a positive family history for spondyloarthritis

Exclusion Criteria:

  • Individuals that are under the age of 18
  • Prisoners
  • Pregnant women
  • Individuals that are functionally illiterate or unable to complete the questionnaires
  • Non-English speaking subjects

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-20309708

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