Rheumatology Patient Registry and Biorepository
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ClinicalTrials.gov Identifier: NCT04402086 |
Recruitment Status :
Recruiting
First Posted : May 26, 2020
Last Update Posted : October 8, 2021
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Condition or disease |
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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 |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 5000 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 10 Years |
Official Title: | Rheumatology Patient Registry and Biorepository |
Actual Study Start Date : | August 4, 2020 |
Estimated Primary Completion Date : | June 1, 2030 |
Estimated Study Completion Date : | June 1, 2040 |

Group/Cohort |
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Biorepository
Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue).
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- Correlate outcomes and biomarkers of rheumatic diseases [ Time Frame: 10 years ]Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402086
Contact: Alyssa Williams | 203-737-5571 | alyssa.williams@yale.edu |
United States, Connecticut | |
Yale New Haven Hospital | Recruiting |
New Haven, Connecticut, United States, 06510 | |
Contact 203-737-5571 | |
Principal Investigator: Monique Hinchcliff, MD |
Principal Investigator: | Monique Hinchcliff, MD | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT04402086 |
Other Study ID Numbers: |
2000026608 |
First Posted: | May 26, 2020 Key Record Dates |
Last Update Posted: | October 8, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Spondylitis Lyme Disease Arthritis, Reactive Arthritis Arthritis, Psoriatic Spondylitis, Ankylosing Rheumatic Diseases Sjogren's Syndrome Dermatomyositis Polymyalgia Rheumatica Polymyositis Still's Disease, Adult-Onset Behcet Syndrome Giant Cell Arteritis Arteritis |
Sarcoidosis Lupus Erythematosus, Systemic Scleroderma, Systemic Collagen Diseases Connective Tissue Diseases Mixed Connective Tissue Disease Undifferentiated Connective Tissue Diseases Antiphospholipid Syndrome Syndrome Disease Pathologic Processes Joint Diseases Musculoskeletal Diseases Arthritis, Rheumatoid Autoimmune Diseases |