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Registry for African Americans With Early Rheumatoid Arthritis (CLEAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00074555
Recruitment Status : Completed
First Posted : December 17, 2003
Last Update Posted : January 6, 2016
Information provided by (Responsible Party):
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Brief Summary:
The purpose of this study is to better understand the causes of rheumatoid arthritis (RA), particularly in African Americans.

Condition or disease
Rheumatoid Arthritis

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 357 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consortium for the Longitudinal Evaluation of African Americans With Early Rheumatoid Arthritis (CLEAR)
Study Start Date : January 2001
Actual Primary Completion Date : December 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Radiographic severity of rheumatoid arthritis in African Americans [ Time Frame: 5 yr disease duration ]
    Initially seen at 5 yr disease duration. Later, became a cross-sectional (1 time visit).

Biospecimen Retention:   Samples With DNA
serum, DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
African Americans

Inclusion Criteria

  • African American
  • Rheumatoid arthritis for less than 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00074555

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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
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: S. Louis Bridges, Jr., MD, PhD University of Alabama at Birmingham
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Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Identifier: NCT00074555    
Other Study ID Numbers: N01 AR02247
First Posted: December 17, 2003    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
African American, Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases