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

Rheumatoid Arthritis Clinical Trial

— CLEAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815425
• Other study ID #: N01 AR002278
• Secondary ID: N01AR62278-6-0-1
• Status: Completed
• Phase: N/A
• First received: December 29, 2008
• Last updated: December 1, 2014
• Start date: September 2000
• Est. completion date: March 2012

Study information

• Verified date: December 2014
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1613
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria for Group 1 Participants:

• Rheumatoid arthritis

• Self-declared as African American

Exclusion Criteria for Group 1 Participants:

• Lupus

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	University of Alabama at Birmingham

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		Measured at any point during the duration of disease	No