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, Md.: 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 and cartilage.


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