Rheumatology Patient Registry and Biorepository

NCT04402086 | Recruiting DMC

• 2 other identifiers: 2000026608No NIH funding
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Correlate outcomes and biomarkers of rheumatic diseases

  Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.

  10 years

Study Arms (1)

Biorepository

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• Rheumatology Research Foundation: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, urine, stool, and tissue/skin biopsies.

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Arthritis, Infectious; Infections; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases, Vascular; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Arteritis; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases

Study Officials

• Monique Hinchcliff, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Perez, MS, BS

CONTACT

203-737-5571; s.perez@yale.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: August 4, 2020
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)