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5,000 patients join Yale's quest to crack rheumatic disease mysteries

NCT ID NCT04402086

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is building a large registry and biorepository of 5,000 adults with various rheumatic diseases like rheumatoid arthritis, lupus, and scleroderma. Researchers at Yale University will collect medical data and biological samples over time to better understand these conditions and find links between outcomes and biomarkers. The goal is to support future research that could lead to improved diagnosis and treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this registry could help researchers discover new biomarkers and improve understanding of rheumatic diseases, pointing toward better diagnostics or treatments.
What could go wrong
This is an observational registry, not a treatment trial. It may not directly lead to new therapies, and results depend on participant diversity and data quality.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

adult-onset Still disease ankylosing spondylitis antiphospholipid syndrome Behcet disease dermatomyositis diffuse scleroderma Giant Cell Arteritis Lyme disease mixed connective tissue disease polymyalgia rheumatica polymyositis psoriatic arthritis reactive arthritis rheumatic disorder rheumatoid arthritis sarcoidosis scleroderma Sjogren syndrome systemic lupus erythematosus systemic sclerosis temporal arteritis Undifferentiated Connective Tissue Diseases undifferentiated connective tissue syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult-onset Still disease Ankylosing spondylitis Antiphospholipid syndrome Behcet disease Dermatomyositis Giant cell arteritis Lyme disease Mixed connective tissue disease Polymyalgia rheumatica Polymyositis Psoriatic arthritis Reactive arthritis Rheumatic diseases Rheumatoid arthritis Sarcoidosis Scleroderma Sjogren's syndrome Systemic lupus erythematosus Systemic sclerosis Undifferentiated connective tissue diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.