Rheumatoid Arthritis Clinical Trial
Official title:
Consortium for the Longitudinal Evaluation of African-Americans With Early Rheumatoid Arthritis (CLEAR) Registry
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.
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.
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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