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, 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.