Who may be eligible for the Rheumatology Patient Registry and Biorepository trial?

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).

ClinicalTrials.gov record NCT04402086

Rheumatology Patient Registry and Biorepository

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Rheumatology Patient Registry and Biorepository

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age18 years old to 99 years old

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational registry collects clinical information and biological samples from people with rheumatic diseases and healthy volunteers. Samples may include blood, saliva, urine, stool, and tissue; data and samples are stored in a biorepository for future research. The project aims to support clinical, basic science, and translational studies over a 10-year period.

What it is studying. The study builds a biorepository that links clinical data and biospecimens so researchers can compare different rheumatic diseases and study disease causes, biomarkers, and outcomes.

What the researchers hope to learn. To create a shared resource of clinical data and biospecimens to enable comparative analyses across rheumatic diseases, to evaluate clinical data and biomarkers, and to increase understanding of disease pathogenesis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join, study staff will collect and use your clinical information and ask you to give one or more biological samples such as blood, saliva, urine, and stool. Some participants may be asked to donate tissue via a skin biopsy; skin biopsies are an additional, more invasive procedure and have special restrictions (for example, pregnant people are asked to wait, and people with allergies to lidocaine or epinephrine or with impaired wound healing cannot donate a skin biopsy). Samples and clinical data will be stored in a biorepository and may be used for research over a period of up to 10 years.

How the study is structured. A prospective observational registry. Participants (people with rheumatic diseases and healthy volunteers) provide clinical information and biological samples, which are stored in a biorepository. No experimental treatments are assigned. Participants may be followed and contribute samples and data over time, up to 10 years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Rheumatic Diseases; Adult Onset Still Disease; Ankylosing Spondylitis; Psoriatic Arthritis; Reactive Arthritis; Antiphospholipid Syndrome; Systemic Lupus Erythematosus; Behcet Disease; Dermatomyositis; Polymyositis; Giant Cell Arteritis; Lyme Disease; Mixed Connective Tissue Disease; Polymyalgia Rheumatica; Rheumatoid Arthritis; Sarcoidosis; Systemic Sclerosis; Scleroderma; Sjogren's Syndrome; Undifferentiated Connective Tissue Diseases. Does it apply to my diagnosis?
This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

This trial is also listed on this site under adult-onset Still's disease, Behçet's disease, dermatomyositis and polymyositis.

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Aug 4, 2020
Primary completion: Jun 1, 2030 (estimated)
Study completion: Jun 1, 2030 (estimated)
Target enrollment: 5000 participants (estimated)
Last updated on registry: Feb 13, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Yale University
Collaborators: Rheumatology Research Foundation

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Stephanie Perez, MS, BS 📞 203-737-5571 ✉ s.perez@yale.edu

Participating sites (1)

Yale New Haven HospitalRecruiting
New Haven, Connecticut, 06510 · United States
- · 203-737-5571
- Monique Hinchcliff, MD

Terms used on this page · explanations by MedicalUpdates.ai

informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
biopsy: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
biorepository: A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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