Registry for African Americans With Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— CLEAR  

Official title:

Consortium for the Longitudinal Evaluation of African Americans With Early Rheumatoid Arthritis (CLEAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074555
• Other study ID #: N01AR02247
• Secondary ID: NIAMS-106
• Status: Completed
• Phase: N/A
• First received: December 16, 2003
• Last updated: January 5, 2016
• Start date: January 2001
• Est. completion date: March 2012

Study information

• Verified date: January 2016
• Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• African American

• Rheumatoid arthritis for less than 2 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
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	Washington University at St. Louis	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic severity of rheumatoid arthritis in African Americans	Initially seen at 5 yr disease duration. Later, became a cross-sectional (1 time visit).	5 yr disease duration	No