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RecruitingNCT04402086Updated Feb 13, 2026

Rheumatology Patient Registry and Biorepository

An observational study in Rheumatic Diseases, Adult Onset Still Disease and Ankylosing Spondylitis, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Yale University · Observational

From the registry’s dates

  • Started Aug 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

In context

Rheumatic Diseases

264 studies on the registry are indexed under Rheumatic Diseases; 60 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 225 across 90 observational studies indexed under Rheumatic Diseases.

Browse Rheumatic Diseases studies →

Lead sponsor

Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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.

Eligibility criteria

Inclusion Criteria for Rheumatology Patients:

  • Patients ≥18 years old with a diagnosis of a rheumatic 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
  • 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 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

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).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Biorepository

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

06

What researchers measure

Primary outcomes

  1. Correlate outcomes and biomarkers of rheumatic diseases

    Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Yale New Haven Hospital
    New Haven, Connecticut 06510, United States
    Recruiting
    • · Contact203-737-5571
    • Monique Hinchcliff, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No — No plan at this time.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2020 (actual). Primary completion is estimated for Jun 2030, 117 months after the start.

Of 36 observational studies under Rheumatic Diseases, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 14. This study's planned 117 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2020
First posted
May 26, 2020
StartActual
Aug 4, 2020
Primary completionEst.
Jun 1, 2030
CompletionEst.
Jun 1, 2030
Last update
Feb 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04402086
Lead sponsor
Yale University
Collaborators
Rheumatology Research Foundation
Responsible party
Sponsor
First posted
May 26, 2020
Start date
Aug 4, 2020
Primary completion
Jun 1, 2030 (estimated)
Completion
Jun 1, 2030 (estimated)
Last update
Feb 13, 2026

Study contacts

Stephanie Perez, MS, BS
Contact
s.perez@yale.edu
203-737-5571
Monique Hinchcliff, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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