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Yale Rheumatology Program Patient Registry and Bio-Repository

  • Study HIC#:2000026608REG
  • Last Updated:05/27/2020

The purpose of this study is to establish a Rheumatology Patient Registry and Bio-repository to facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

  • Age18 years - 99 years
  • GenderBoth
  • Start Date05/10/2020
  • End Date05/31/2030

Trial Purpose and Description

The primary objective is to establish a Rheumatology Patient Registry and Bio-repository to facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases including, but not limited to: adult onset Still s disease, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, antiphospholipid syndrome, systemic lupus erythematosus, Behcet s disease, dermatomyositis, polymyositis, giant cell arteritis and other vasculitides, Lyme s disease, mixed connective tissue disease, polymyalgia rheumatica, rheumatoid arthritis, sarcoidosis, systemic sclerosis (scleroderma), Sjogren s syndrome, and undifferentiated connective tissue disease.

A registry will permit exploratory feasibility analyses to be conducted to determine if a sufficient number of patients with a specific disease are currently receiving care at YNHH for instance. A rheumatology registry will permit comparative analyses between the rheumatic diseases in order to increase our understanding of disease pathogenesis.

Eligibility Criteria

Eligibility criteria

    1. Inclusion Criteria for Rheumatology Patients: 
      1. Patients ≥18 years old with a diagnosis of a rheumatic autoimmune disease including, but not limited to: adult onset Still’s disease, ankylosing spondylitis, antiphospholipid syndrome, Behcet’s disease, dermatomyositis, giant cell arteritis, mixed connective tissue disease, polymyalgia rheumatica, polymyositis, psoriatic arthritis, reactive arthritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren’s syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease and vasculitis.
    2. Exclusion Criteria for Rheumatology Patients:
      1.  Unable to provide informed consent 
      2. No patients will be excluded based on gender or ethnicity or pregnancy status.
      3. Women who are currently pregnant will need to wait to donate a skin biopsy until after they deliver. 
      4. Patients allergic to lidocaine or epinephrine or have a history of impaired wound healing will not be able to donate a skin biopsy
    3. Inclusion Criteria for Healthy Volunteers: 
      1. Age ≥ 18 years old. 
      2. No chronic skin conditions. 
      3. No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis). 
      4. Normal BMI
    4. Exclusion Criteria for Healthy Volunteers: 
      1. Unable to provide informed consent. 
      2. Currently pregnant or nursing unless the study goal is to study pregnant or nursing woman. 
      3. Allergies to lidocaine or epinephrine (skin biopsies). 
      4. A history of impaired wound healing (skin biopsies).