Clinical trial NCT04402086: Rheumatology Patient Registry and Biorepository
Official title: Rheumatology Patient Registry and Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatic Diseases
Adult Onset Still Disease
Ankylosing Spondylitis
Psoriatic Arthritis
Reactive Arthritis
Antiphospholipid Syndrome
Systemic Lupus Erythematosus
Behcet Disease
Dermatomyositis
Polymyositis
Giant Cell Arteritis
Lyme Disease
Mixed Connective Tissue Disease
Polymyalgia Rheumatica
Rheumatoid Arthritis
Sarcoidosis
Systemic Sclerosis
Scleroderma
Sjogren's Syndrome
Undifferentiated Connective Tissue Diseases
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Rheumatology Research Foundation
First posted: 2020-05-26
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The biorepository will consist of both new and established patients with a rheumatic autoimmune disease diagnosis who visit a Yale Rheumatology medical facility and agree to participate in this study. The biorepository will also consist of healthy volunteers who agree to participate in this study.

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

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Correlate outcomes and biomarkers of rheumatic diseases
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Monique Hinchcliff, MD
role: PRINCIPAL_INVESTIGATOR
References: