Clinical trial NCT00074555: Registry for African Americans With Early Rheumatoid Arthritis
Official title: Consortium for the Longitudinal Evaluation of African Americans With Early Rheumatoid Arthritis (CLEAR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: African American, Rheumatoid Arthritis
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sponsor class: NIH
First posted: 2003-12-17
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African Americans

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

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 criteria: Inclusion Criteria

* African American
* Rheumatoid arthritis for less than 2 years

Primary outcomes:
measure: Radiographic severity of rheumatoid arthritis in African Americans
timeFrame: 5 yr disease duration
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: St. Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of Alabama at Birmingham
name: S. Louis Bridges, Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: