Rheumatic DiseasesNCT04402086
Rheumatology Patient Registry and Biorepository
An observational study of Rheumatic Diseases and Adult Onset Still Disease, run by Yale University at 1 site in United States.
Trial summary
To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases, Adult Onset Still Disease, Ankylosing Spondylitis
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2020to 1 Jun 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
- Age ≥ 18 years old
- No chronic skin conditions
- No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)
- Normal BMI
Who cannot join
- 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.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
203-737-5571
Monique Hinchcliff, MD
About this study
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.
- Conditions
- Rheumatic Diseases, Adult Onset Still Disease, Ankylosing Spondylitis, Psoriatic Arthritis, Reactive Arthritis, Antiphospholipid Syndrome
- Medical subject headings
- Rheumatic Diseases, Still's Disease, Adult-Onset, Spondylitis, Ankylosing, Arthritis, Psoriatic, Arthritis, Reactive, Antiphospholipid Syndrome, Lupus Erythematosus, Systemic, Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biorepository | Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate outcomes and biomarkers of rheumatic diseases
Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start4 Aug 2020
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Responsible party
- Sponsor
- Investigators
- Monique Hinchcliff, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402086
- Sponsor's protocol ID
- 2000026608
- Other IDs
- No NIH funding
- Status last verified
- Feb 2026
- First submitted
- 20 May 2020
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this time.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatology Patient Registry and Biorepository
- ClinicalTrials.gov ID
- NCT04402086
- Acronym / sponsor ID
- 2000026608
- Conditions
- Rheumatic Diseases, Adult Onset Still Disease, Ankylosing Spondylitis, Psoriatic Arthritis, Reactive Arthritis, Antiphospholipid Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biorepository | – | –Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
- Age ≥ 18 years old
- No chronic skin conditions
- No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)
Key exclusion criteria (8 listed)
- 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.
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlate outcomes and biomarkers of rheumatic diseases
Time frame: 10 years
Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. No plan at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monique Hinchcliff, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and Adult Onset Still Disease, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Perez, MS, BS (203-737-5571, s.perez@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate outcomes and biomarkers of rheumatic diseases (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.