Registry for African Americans With Early Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00074555
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2003-12-16
• Study First Submitted QC: 2003-12-16
• Study First Posted: 2003-12-17
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic severity of rheumatoid arthritis in African Americans	5 yr disease duration	Initially seen at 5 yr disease duration. Later, became a cross-sectional (1 time visit).

Trial Locations

Locations (5)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Washington University at St. Louis; 🇺🇸 St. Louis, Missouri, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States