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Rheumatology Patient Registry and Biorepository

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Yale University

Status

Enrolling

Conditions

Polymyalgia Rheumatica
Giant Cell Arteritis
Dermatomyositis
Antiphospholipid Syndrome
Reactive Arthritis
Sjogren's Syndrome
Mixed Connective Tissue Disease
Behcet Disease
Systemic Sclerosis
Lyme Disease
Psoriatic Arthritis
Systemic Lupus Erythematosus
Sarcoidosis
Polymyositis
Adult Onset Still Disease
Scleroderma
Undifferentiated Connective Tissue Diseases
Ankylosing Spondylitis
Rheumatic Diseases
Rheumatoid Arthritis

Study type

Observational

Funder types

Other

Identifiers

NCT04402086
2000026608
No NIH funding (Other Identifier)

Details and patient eligibility

About

To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

Full description

A rheumatology biorepository will be created to permit comparative analyses between the rheumatic diseases in order to increase the understanding of disease pathogenesis. Patients seen at Yale clinics diagnosed with rheumatic diseases are invited to participate in this study. These rheumatic diseases include, but are 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.

Enrollment

5,000 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Rheumatology Patients:

  • 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.
  • Receiving clinical care at Yale Rheumatology clinics

Exclusion Criteria for Rheumatology Patients:

  • Unable to provide informed consent
  • No patients will be excluded based on gender or ethnicity or pregnancy status.
  • Women who are currently pregnant will need to wait to donate a skin biopsy until after they deliver.
  • Patients allergic to lidocaine or epinephrine or have a history of impaired wound healing will not be able to donate a skin biopsy.

Inclusion Criteria for Healthy Volunteers:

  • Age ≥ 18 years old
  • No chronic skin conditions
  • No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)
  • Normal BMI

Exclusion Criteria for Healthy Volunteers:

  • Unable to provide informed consent.
  • Currently pregnant or nursing unless the study goal is to study pregnant or nursing woman.
  • Allergies to lidocaine or epinephrine (skin biopsies).
  • A history of impaired wound healing (skin biopsies).

Trial design

5,000 participants in 1 patient group

Biorepository
Description:
Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue).

Trial contacts and locations

1

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Central trial contact

Stephanie Perez, MS, BS

Data sourced from clinicaltrials.gov

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