Rheumatic DiseasesNCT00024479
Studies of the Natural History of Rheumatic Diseases
An observational study of Rheumatic Diseases and Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatic Diseases, Arthritis
- How many people
- 7,500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2001to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults, older than or equal to 18 years of age, referred from the community
Who may be able to join
- Known or suspected rheumatic disease
- Age greater than or equal to 18 years
- Willingness and capacity to provide informed consent.
Who cannot join
- Patients will be excluded if any of the inclusion criteria cannot be met.
- Women who are pregnant or breastfeeding at the time of enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the 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 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
- Rheumatic Diseases, Arthritis
- Keywords
- Minorities, Rheumatic Disease, Community Based, Natural History, Ethnicity, Health Disparities
- Medical subject headings
- Rheumatic Diseases, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| suspected or confirmed rheumatic disease | autoimmune, autoinflammatory, or degenerative conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 31 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2001 (estimated)
- Study start3 Oct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sarfaraz A Hasni, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024479
- Sponsor's protocol ID
- 010227
- Other IDs
- 01-AR-0227
- Status last verified
- 30 Jun 2026
- First submitted
- 14 Sep 2001
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The protocol is silent on IPD.
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.
PubMed 9663471Lawrence 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.
PubMed 9588729Jordan 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.
PubMed 10319211