Natural History of Rheumatic Diseases in Minority Communities

Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00024479
Collaborator
(none)
7,500
1

Study Details

Study Description

Brief Summary

This study will explore the causes of rheumatic diseases and why many of them affect certain minority communities more severely. Rheumatic diseases may cause joint pain, stiffness or swelling. Some can involve bones, muscles, tendons or ligaments. Some cause abnormalities of the immune system the body s defense against disease. Some rheumatic diseases are painful or deforming and some can be life threatening. Information obtained from this study will be used to learn about the disparities in rheumatic disease in the minority community and to design further, more targeted, research studies to address this issue.

Patients with known or suspected rheumatic disease 18 years of age or older may be eligible for this study. Candidates will undergo a medical history and physical examination to confirm the diagnosis of rheumatic disease and determine what is needed for evaluation and treatment.

Participants will receive standard medical care for rheumatic disease and arthritis. No experimental treatments, medications or procedures will be included in this study. Procedures may include routine blood tests for blood chemistries, cell counts, and antibodies commonly found in patients with rheumatic disease; a urine test for proteins and cells; and X-rays and other imaging tests to check for abnormalities in the lungs or other organs. All medical information will be kept confidential.

Patients who are found to be eligible for other current NIH research studies will be offered an opportunity to participate in these studies.

...

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This protocol will permit the evaluation and treatment of subjects who are members of the minority community, for the purpose to facilitate understanding the pathogenesis and natural history of rheumatic diseases in this community. Patients will be evaluated with a history and physical examination and routine laboratory studies will be obtained as needed to assess diagnosis, disease activity, disease complications and to monitor for treatment-related responses and toxicities. Patients eligible for other research protocols will be offered an opportunity to participate in these studies by signed informed consent. Any medical care recommended or provided to the patient will be consistent with routine standards of practice and will be provided in consultation with the patient s referring physician. All patients referred to this study must have a primary care provider provide a referral. The establishment of this protocol will provide a means to evaluate and treat patients from the minority community, and to generate hypotheses and protocols based on this clinical experience that will address questions of health disparities in the rheumatic diseases.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    7500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Studies of the Natural History of Rheumatic Disease in Minority Communities
    Actual Study Start Date :
    Oct 3, 2001

    Arms and Interventions

    Arm Intervention/Treatment
    suspected or confirmed rheumatic disease

    autoimmune, autoinflammatory, or degenerative conditions

    Outcome Measures

    Primary Outcome Measures

    1. To generate hypotheses relating to the basis and/or effects of health disparities in the community, which may serve as the basis for subsequent research efforts based in the community and/or at the NIH Clinical Center [31 Years]

      The rheumatological health of the community

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    Known or suspected rheumatic disease

    Age greater than or equal to 18 years

    Willingness and capacity to provide informed consent.

    EXCLUSION CRITERIA:

    Patients will be excluded if any of the inclusion criteria cannot be met.

    Women who are pregnant or breastfeeding at the time of enrollment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    Investigators

    • Principal Investigator: Sarfaraz A Hasni, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    ClinicalTrials.gov Identifier:
    NCT00024479
    Other Study ID Numbers:
    • 010227
    • 01-AR-0227
    First Posted:
    Sep 14, 2001
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 18, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 23, 2022