New Study to Show How Rheumatoid Arthritis Patients Rate Improvement Change
A new clinical study to determine how people with rheumatoid arthritis
(RA) evaluate improvements in disease symptoms will be carried out
by the National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS), part of the Department of Health and Human Services'
National Institutes of Health. The study will examine how much of
an improvement in pain, stiffness, function and other symptoms is
needed before patients consider the change important.
The Clinically Important Changes in Rheumatoid Arthritis
study will recruit 300 people 18 years of age or older who have
been diagnosed with RA. Researchers are particularly interested
in patients who are currently being treated with prednisone, methotrexate,
leflunomide, infliximab or etanercept.
Patients will be evaluated twice at the NIH Clinical Center in
Bethesda, Maryland: once at the start of the study and again over
a 1- to 4-month period. At each visit, patients will undergo assessments,
including a physical exam, a grip strength test, a walking test
and a blood test. They will complete a computer-based exercise,
and answer written questionnaires.
The questionnaires will ask patients to rate the importance of
change in pain, morning stiffness, fatigue, joint swelling, functioning,
worry, depression and overall impressions since the first visit.
Many people with RA complain about the daily joint pain that is
associated with the disease. In addition, doctors have noted that
patients have feelings of helplessness, depression and anxiety.
These symptoms together can interfere with a person's ability to
carry out normal daily activities.
Generally, doctors evaluate patients' health and treatment based
on measures such as the number of joints that are tender or swollen,
morning stiffness, grip strength and pain severity. Less attention
is given to whether treatment results are meaningful to patients.
The results of this study will give doctors a measure of the degree
of improvements in symptoms and signs of arthritis that patients
think are important. This will provide a target to be used in evaluating
new treatments. Using these patient-based criteria, doctors will
know if a new treatment has a high likelihood of being rated by
patients as helpful or not.
Rheumatoid arthritis is an autoimmune disease that affects 2.1
million Americans, occurring two to three times more often in women
than in men. RA typically affects many joints and is a chronic ongoing
illness, requiring long periods of observation and management. It
is characterized by inflammation of the membrane lining the joint,
which causes pain, stiffness, warmth, redness and swelling. The
inflamed joint lining, the synovium, can invade and damage bone
For additional information on the RA clinical trial, please contact:
Patient Recruitment and Public Liaison Office
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: (301) 594-9774 (local), 1-866-411-1010 (toll free)
or e-mail at firstname.lastname@example.org
The mission of the National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS), a part of the Department of Health and
Human Services' National Institutes of Health, is to support research
in the causes, treatment and prevention of arthritis and musculoskeletal
and skin diseases, the training of basic and clinical scientists
to carry out this research and the dissemination of information
on research progress in these diseases. For more information about
NIAMS, call the information clearinghouse at (301) 495-4484 or (877)
22-NIAMS or visit the NIAMS Web site at http://www.niams.nih.gov.