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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00815425
First received: December 29, 2008
Last updated: May 5, 2009
Last verified: May 2009
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Consortium for the Longitudinal Evaluation of African-Americans With Early Rheumatoid Arthritis (CLEAR) Registry

Resource links provided by NLM:


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

Blood, including DNA and serum, and urine


Estimated Enrollment: 1500
Study Start Date: September 2000
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
1000 participants with RA
African-Americans without RA
500 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 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Bridges, Jr, MD, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: S. Louis Bridges, Jr. MD, PhD, University of Alabama at Birmingham, Department of Medicine
ClinicalTrials.gov Identifier: NCT00815425     History of Changes
Other Study ID Numbers: N01 AR002278
Study First Received: December 29, 2008
Last Updated: May 5, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014