Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT04402086

Conditions

Rheumatic Diseases

Adult Onset Still Disease

Ankylosing Spondylitis

Psoriatic Arthritis

Reactive Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Rheumatic Diseases

Adult Onset Still Disease

Ankylosing Spondylitis

Psoriatic Arthritis

Reactive Arthritis

Study ID

NCT04402086

Start date

Aug 4, 2020

Status verified date

Feb, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Biorepository

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

Primary outcome measure

  • Correlate outcomes and biomarkers of rheumatic diseases [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Stephanie Perez, MS, BS

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

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Principal Investigator:

Monique Hinchcliff, MD

More Information

Sponsor

Yale University

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Yale University on 2026-02-13.