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Long-Term Evaluation of African Americans With Early Rheumatoid Arthritis (The CLEAR Study)
This study is currently recruiting participants.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), December 2008
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00815425
  Purpose

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.


Condition
Rheumatoid Arthritis

MedlinePlus related topics: Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Cross-Sectional
Official Title: Continuation of the Consortium for the Longitudinal Evaluation of African-Americans With Early Rheumatoid Arthritis (CLEAR)

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Radiographic severity of rheumatoid arthritis in African Americans [ Time Frame: Measured at any point during the duration of disease ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood, including DNA and serum, and urine


Estimated Enrollment: 900
Study Start Date: September 2006
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
African Americans with RA
600 participants with RA
African-Americans without RA
300 participants without RA

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 without RA and African Americans with RA. There will be one study visit for all participants, which will last approximately 1 to 2 hours for participants without RA 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. 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. Another part of the blood samples will be used for possible future medical research. And last, 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. Participants will be told of the results of their blood and urine tests. However, participants will not be provided with any information on their genes.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

African Americans with and without RA

Criteria

Inclusion Criteria for Group 1 Participants:

  • Rheumatoid arthritis
  • Self-declared as African American

Exclusion Criteria for Group 1 Participants:

  • Lupus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815425

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Stephanie Ledbetter     205-934-7423     stephanie.ledbetter@ccc.uab.edu    
Sponsors and Collaborators
Investigators
Principal Investigator: S. Louis Bridge, Jr, MD, PhD University of Alabama at Birmingham
  More Information

Responsible Party: University of Alabama at Birmingham, Department of Medicine ( S. Louis Bridges, Jr. MD, PhD )
Study ID Numbers: N01 AR002278
Study First Received: December 29, 2008
Last Updated: December 29, 2008
ClinicalTrials.gov Identifier: NCT00815425  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
African American

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009