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Studies of the Natural History of Rheumatic Diseases

NCT ID: NCT00024479

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-10-03

Brief Summary

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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.

Detailed Description

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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 health 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.

Conditions

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Rheumatic Diseases Arthritis

Keywords

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Minorities Rheumatic Disease Community Based Natural History Ethnicity Health Disparities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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suspected or confirmed rheumatic disease

autoimmune, autoinflammatory, or degenerative conditions

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Known or suspected rheumatic disease

Age greater than or equal to 18 years

Willingness and capacity to provide informed consent.


Women who are pregnant or breastfeeding at the time of enrollment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarfaraz A Hasni, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nancy A Spencer

Role: CONTACT

Phone: (301) 827-0186

Email: [email protected]

Sarfaraz A Hasni, M.D.

Role: CONTACT

Phone: (301) 451-1599

Email: [email protected]

Facility Contacts

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For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Role: primary

References

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Reveille JD, Moulds JM, Ahn C, Friedman AW, Baethge B, Roseman J, Straaton KV, Alarcon GS. Systemic lupus erythematosus in three ethnic groups: I. The effects of HLA class II, C4, and CR1 alleles, socioeconomic factors, and ethnicity at disease onset. LUMINA Study Group. Lupus in minority populations, nature versus nurture. Arthritis Rheum. 1998 Jul;41(7):1161-72. doi: 10.1002/1529-0131(199807)41:73.0.CO;2-K.

Reference Type BACKGROUND
PMID: 9663471 (View on PubMed)

Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.

Reference Type BACKGROUND
PMID: 9588729 (View on PubMed)

Jordan JM. Effect of race and ethnicity on outcomes in arthritis and rheumatic conditions. Curr Opin Rheumatol. 1999 Mar;11(2):98-103. doi: 10.1097/00002281-199903000-00003.

Reference Type BACKGROUND
PMID: 10319211 (View on PubMed)

Related Links

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https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2001-AR-0227.html

NIH Clinical Center Detailed Web Page

Other Identifiers

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01-AR-0227

Identifier Type: -

Identifier Source: secondary_id

010227

Identifier Type: -

Identifier Source: org_study_id