Clinical Trial Finder

Rheumatology Patient Registry and Biorepository

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational [Patient Registry]
Eligible Ages 18 Years - 99 Years
Gender All
More 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04402086
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Yale University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Monique Hinchcliff, MD
Principal Investigator Affiliation Yale University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being 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
Additional Details

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.

Arms & Interventions

Arms

: Biorepository

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale New Haven Hospital, New Haven, Connecticut

Status

Recruiting

Address

Yale New Haven Hospital

New Haven, Connecticut, 06510

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