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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00074555 |
The purpose of this study is to better understand the causes of rheumatoid arthritis (RA), particularly in African Americans.
Condition |
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Rheumatoid Arthritis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Consortium for the Longitudinal Evaluation of African Americans With Early Rheumatoid Arthritis (CLEAR) |
serum, DNA
Enrollment: | 357 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | September 2011 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
RA is an autoimmune disease in which the body's immune system attacks its own tissues. It occurs in all races and ethnic groups and affects about two to three times as many women as men. Variations in certain genes that play a role in the immune system are associated with a tendency to develop RA. Some individuals without these genetic variations may develop this disease, while others who possess the variations never develop RA. Scientists believe that some environmental factors may play a part in triggering the disease process in people whose genetic makeup makes them susceptible to RA. This registry of African Americans with early RA will provide clinical and x-ray data and DNA to help scientists analyze genetic and nongenetic factors that might predict disease course and outcomes of RA in this population.
Participants in this registry will be enrolled in the study until they reach 5 years in their disease duration. For example, if a participant enters the study after 1 year of having RA, he or she will continue for 4 years. Participants will have three office visits (screening, 3 years' disease duration, and 5 years' disease duration) at which they will complete questionnaires and have blood samples taken, x-rays of their hands and feet, and DEXA scans.
Between office visits, the study coordinator will call participants every 6 months to update any changes in medications or health problems.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
African Americans
Inclusion Criteria
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30303 | |
United States, Missouri | |
Washington University at St. Louis | |
St. Louis, Missouri, United States, 63130 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | S. Louis Bridges, Jr., MD, PhD | University of Alabama at Birmingham |
Responsible Party: | UAB School of Medicine, Rheumatology Div. ( S. Louis Bridges, Jr. MD PhD ) |
Study ID Numbers: | N01 AR02247, NIAMS-106 |
Study First Received: | December 16, 2003 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00074555 History of Changes |
Health Authority: | United States: Federal Government |
African American, Rheumatoid Arthritis |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |