Rheumatology Patient Registry and Biorepository

Rheumatoid Arthritis Clinical Trial

Official title:

Rheumatology Patient Registry and Biorepository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402086
• Other study ID #: 2000026608
• Secondary ID: No NIH funding
• Status: Recruiting
• Start date: August 4, 2020
• Est. completion date: June 1, 2030

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: Nicolas Page
• Phone: 203-737-5571
• Email: scleroderma[@]yale.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 1, 2030
• Est. primary completion date: June 1, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Rheumatology Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate outcomes and biomarkers of rheumatic diseases	Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.	10 years