Rheumatology Patient Registry and Biorepository

NCT ID: NCT04402086

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2030-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Biorepository

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


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

Exclusion Criteria

* 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.


* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rheumatology Research Foundation

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monique Hinchcliff, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stephanie Perez, MS, BS

Role: CONTACT

203-737-5571

Facility Contacts

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Role: primary

203-737-5571

Other Identifiers

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No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000026608

Identifier Type: -

Identifier Source: org_study_id

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