Natural History of Rheumatic Diseases in Minority Communities

Studies of the Natural History of Rheumatic Disease in Minority Communities

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis; Rheumatic Diseases

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 Type: Observational
• Enrollment (Estimated): 7500

Contacts and Locations

• Study Contact: Name: Nancy A Spencer; Phone Number: (301) 827-0186; Email: nancy.spencer@nih.gov
• Study Contact Backup: Name: Sarfaraz A Hasni, M.D.; Phone Number: (301) 451-1599; Email: hasnisa@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults, older than or equal to 18 years of age, referred from the community

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
suspected or confirmed rheumatic disease; autoimmune, autoinflammatory, or degenerative conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The rheumatological health of the community	31 Years

Collaborators and Investigators

• Sponsor: 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)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2001
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: September 14, 2001
• First Submitted That Met QC Criteria: September 13, 2001
• First Posted (Estimated): September 14, 2001

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 4, 2024

More Information

Terms related to this study

• Keywords: Natural History; Minorities; Rheumatic Disease; Community Based; Ethnicity; Health Disparities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: 010227; 01-AR-0227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .The protocol is silent on IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No