Rheumatology Patient Registry and Biorepository

February 11, 2026 updated by: Yale University
To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

Study Overview

Status

Recruiting

Conditions

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stephanie Perez, MS, BS
  • Phone Number: 203-737-5571
  • Email: s.perez@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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

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
Time Frame: 10 years
Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Rheumatology Research Foundation

Investigators

  • Principal Investigator: Monique Hinchcliff, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000026608
  • No NIH funding (Other Identifier: 11.09.23)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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