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

NCT ID: NCT00815425

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1613 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2012-03-31

Brief Summary

Rheumatoid arthritis (RA) is a long-term autoimmune disease that is characterized by pain, stiffness, inflammation, swelling, and sometimes destruction of joints. RA usually requires lifelong treatment, including medications, physical therapy, exercise, education, and possibly surgery, but the course and severity of the disease can differ significantly from person to person. The purpose of this study is to identify genetic and other factors that determine the severity of RA in African Americans.

Detailed Description

RA is a chronic condition that causes inflammation of the joints and surrounding tissues. Symptoms may include pain, stiffness, swelling, and sometimes destruction of joints. RA can affect any joint, but it is most common in the wrist and fingers. More women than men get RA, and it often starts between the ages of 25 and 55. The course and severity of the disease can differ significantly from person to person. Some people with RA may have the disease for only a short time, or their symptoms might come and go, but the severe form of RA can last a lifetime. The purpose of this study is to identify genetic and other factors that determine the severity of RA in African Americans.

Participants in this study will include African Americans with RA and healthy African Americans with RA. There are two arms: (1) longitudinal; and (2) cross-sectional. The longitudinal arm has completed enrollment and is still in the follow-up phase. This consists of visits at baseline (less than 2 years disease duration; 3 years disease duration; and 5 years disease duration).

For the cross-sectional arm, there will be one study visit for all participants, which will last approximately 1 to 2 hours for participants without RA (controls) and 2 to 3 hours for participants with RA. For all participants, this visit will include a medical history review; questionnaires regarding health, functional ability, family, education, and work history; and blood and urine collection. For participants with RA, this visit will also include examination of the joints for pain and swelling, X-rays of the hands and feet, and a physical examination.

The urine samples will be stored for future analyses of protein and chemical markers. The blood samples will be used in three different ways: (1) isolation of DNA; (2) isolation of serum and plasma; and (3) isolation of RNA. Part of the blood samples will be used by the investigators to identify genes or proteins that may predispose people to develop RA or that may influence disease outcome or treatment response. If participants agree, their blood cells will be put through a procedure called immortalization, which will provide researchers with sufficient DNA for all future studies associated with this study and for other related projects. If the immortalization process fails, participants may be asked for an additional blood sample with which to repeat the procedure. However, participants will not be provided with any information on their genes.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

African Americans with RA

1063 participants with RA

No interventions assigned to this group

African-Americans without RA

550 participants without RA

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Rheumatoid arthritis
• Self-declared as African American

Exclusion Criteria

• Lupus

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

S. Louis Bridges, Jr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

N01AR62278-6-0-1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01 AR002278

Identifier Type: -

Identifier Source: org_study_id