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Registry for African Americans With Early Rheumatoid Arthritis (CLEAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00074555
First received: December 16, 2003
Last updated: September 17, 2008
Last verified: September 2008
  Purpose

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


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consortium for the Longitudinal Evaluation of African Americans With Early Rheumatoid Arthritis (CLEAR)

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Biospecimen Retention:   Samples With DNA

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

African Americans

Criteria

Inclusion Criteria

  • African American
  • Rheumatoid arthritis for less than 2 years
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074555

Locations
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
Investigators
Principal Investigator: S. Louis Bridges, Jr., MD, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: S. Louis Bridges, Jr. MD PhD, UAB School of Medicine, Rheumatology Div.
ClinicalTrials.gov Identifier: NCT00074555     History of Changes
Other Study ID Numbers: N01 AR02247, NIAMS-106
Study First Received: December 16, 2003
Last Updated: September 17, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
African American, Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014