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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: | NCT00815425 |
Rheumatoid arthritis (RA) is a long-term autoimmune disease that is characterized by pain, stiffness, inflammation, swelling, and sometimes destruction of joints. RA usually requires lifelong treatment, including medications, physical therapy, exercise, education, and possibly surgery, but the course and severity of the disease can differ significantly from person to person. The purpose of this study is to identify genetic and other factors that determine the severity of RA in African Americans.
Condition |
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Rheumatoid Arthritis |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Continuation of the Consortium for the Longitudinal Evaluation of African-Americans With Early Rheumatoid Arthritis (CLEAR) |
Blood, including DNA and serum, and urine
Estimated Enrollment: | 900 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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African Americans with RA
600 participants with RA
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African-Americans without RA
300 participants without RA
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RA is a chronic condition that causes inflammation of the joints and surrounding tissues. Symptoms may include pain, stiffness, swelling, and sometimes destruction of joints. RA can affect any joint, but it is most common in the wrist and fingers. More women than men get RA, and it often starts between the ages of 25 and 55. The course and severity of the disease can differ significantly from person to person. Some people with RA may have the disease for only a short time, or their symptoms might come and go, but the severe form of RA can last a lifetime. The purpose of this study is to identify genetic and other factors that determine the severity of RA in African Americans.
Participants in this study will include African Americans without RA and African Americans with RA. There will be one study visit for all participants, which will last approximately 1 to 2 hours for participants without RA and 2 to 3 hours for participants with RA. For all participants, this visit will include a medical history review; questionnaires regarding health, functional ability, family, education, and work history; and blood and urine collection. For participants with RA, this visit will also include examination of the joints for pain and swelling, X-rays of the hands and feet, and a physical examination.
The urine samples will be stored for future analyses of protein and chemical markers. The blood samples will be used in three different ways. Part of the blood samples will be used by the investigators to identify genes or proteins that may predispose people to develop RA or that may influence disease outcome or treatment response. Another part of the blood samples will be used for possible future medical research. And last, if participants agree, their blood cells will be put through a procedure called immortalization, which will provide researchers with sufficient DNA for all future studies associated with this study and for other related projects. If the immortalization process fails, participants may be asked for an additional blood sample with which to repeat the procedure. Participants will be told of the results of their blood and urine tests. However, participants will not be provided with any information on their genes.
Ages Eligible for Study: | 45 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
African Americans with and without RA
Inclusion Criteria for Group 1 Participants:
Exclusion Criteria for Group 1 Participants:
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Stephanie Ledbetter 205-934-7423 stephanie.ledbetter@ccc.uab.edu |
Principal Investigator: | S. Louis Bridge, Jr, MD, PhD | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham, Department of Medicine ( S. Louis Bridges, Jr. MD, PhD ) |
Study ID Numbers: | N01 AR002278 |
Study First Received: | December 29, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00815425 |
Health Authority: | United States: Federal Government |
African American |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |