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Rheumatology Patient Registry and Biorepository

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ClinicalTrials.gov Identifier: NCT04402086
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : April 15, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date May 20, 2020
First Posted Date May 26, 2020
Last Update Posted Date April 15, 2021
Actual Study Start Date August 4, 2020
Estimated Primary Completion Date June 1, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2020)
Correlate outcomes and biomarkers of rheumatic diseases [ Time Frame: 10 years ]
Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rheumatology Patient Registry and Biorepository
Official Title Rheumatology Patient Registry and Biorepository
Brief Summary 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 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. Healthy volunteers are also invited to participate in this study.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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.
Condition
  • 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
Intervention Not Provided
Study Groups/Cohorts Biorepository
Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2020)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2040
Estimated Primary Completion Date June 1, 2030   (Final data collection date for primary outcome measure)
Eligibility 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.

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Alyssa Williams 203-737-5571 alyssa.williams@yale.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04402086
Other Study ID Numbers 2000026608
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Undecided
Responsible Party Yale University
Study Sponsor Yale University
Collaborators Not Provided
Investigators
Principal Investigator: Monique Hinchcliff, MD Yale University
PRS Account Yale University
Verification Date April 2021