Rheumatology Patient Registry and Biorepository

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

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Nicolas Page; Phone Number: 203-737-5571; Email: scleroderma@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale New Haven Hospital
      • Contact: Phone Number: 203-737-5571
      • Principal Investigator: Monique Hinchcliff, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Biorepository; Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate outcomes and biomarkers of rheumatic diseases	Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.	10 years

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Rheumatology Research Foundation
• Investigators: Principal Investigator: Monique Hinchcliff, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Infections; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Eye Diseases; Disease Attributes; Disease; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Skin Diseases, Papulosquamous; Hypersensitivity; Spinal Diseases; Bone Diseases; Lacrimal Apparatus Diseases; Spondylarthropathies; Spondylarthritis; Hypersensitivity, Delayed; Psoriasis; Myositis; Vasculitis, Central Nervous System; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Tick-Borne Diseases; Bone Diseases, Infectious; Ankylosis; Borrelia Infections; Spirochaetales Infections; Arthritis, Infectious; Chronic Disease; Post-Infectious Disorders; Axial Spondyloarthritis; Syndrome; Arthritis; Lupus Erythematosus, Systemic; Behcet Syndrome; Scleroderma, Systemic; Arthritis, Psoriatic; Rheumatic Diseases; Collagen Diseases; Connective Tissue Diseases; Dermatomyositis; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis; Still's Disease, Adult-Onset; Sjogren's Syndrome; Antiphospholipid Syndrome; Spondylitis; Spondylitis, Ankylosing; Lyme Disease; Polymyositis; Sarcoidosis; Arthritis, Reactive; Undifferentiated Connective Tissue Diseases; Mixed Connective Tissue Disease
• Other Study ID Numbers: 2000026608; No NIH funding (Other Identifier: 01.22.24)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No