Registry and biorepository for rheumatic diseases
Rheumatology Patient Registry and Biorepository
Yale University · NCT04402086
This study is collecting samples and health information from adults with rheumatic diseases at Yale clinics to help researchers learn more about these conditions and improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04402086 on ClinicalTrials.gov |
What this trial studies
This project aims to create a biorepository for patients diagnosed with various rheumatic diseases at Yale clinics. By collecting biological samples and clinical data, the study will facilitate comparative analyses to enhance the understanding of disease mechanisms and improve future research. The focus includes conditions such as adult onset Still's disease, ankylosing spondylitis, and psoriatic arthritis, among others. Participation is open to adults receiving care at Yale Rheumatology clinics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with a rheumatic autoimmune disease who are receiving care at Yale Rheumatology clinics.
Not a fit: Patients who are unable to provide informed consent or have specific allergies that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to improved understanding and treatment options for patients with rheumatic diseases.
How similar studies have performed: Other studies utilizing biorepositories for rheumatic diseases have shown promise in advancing understanding and treatment, indicating this approach is supported by previous successes.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Monique Hinchcliff, MD — Yale University
- Study coordinator: Stephanie Perez, MS, BS
- Email: s.perez@yale.edu
- Phone: 203-737-5571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rheumatic Diseases, Adult Onset Still Disease, Ankylosing Spondylitis, Psoriatic Arthritis, Reactive Arthritis, Antiphospholipid Syndrome, Systemic Lupus Erythematosus, Behcet Disease