Clinically Important Changes in Rheumatoid Arthritis

Completed

Conditions studied: Rheumatoid Arthritis

In brief

This study will explore how patients with rheumatoid arthritis evaluate, or rate, symptom improvements. Physicians generally evaluate patients health and treatment benefits based on laboratory measures, such as the number of tender or swollen joints, duration of morning stiffness, grip strength, pain severity and others. Less attention is given to whether these treatment results are meaningful to patients. This study will examine how much of an improvement in pain, stiffness, function, and other symptoms is needed before patients consider the change an important improvement. Patients 18 years of age or older who were diagnosed with rheumatoid arthritis after age 16 and who have active arthritis (6 or more tender joints) may be eligible for this study. Of particular interest are patients beginning treatment with prednisone, methotrexate, leflunomide, infliximab, or etanercept, although patients receiving any type of treatment may be included. Participants will be evaluated twice at the NIH Clinical Center, once at the start of the study and again at either 1 month or 4 months later, depending on the individual s treatment regimen. Permission will also be requested to review patients medical records for results of previous blood tests and x-rays. At each NIH visit, patients will undergo the following tests and procedures: * Medical history and physical examination, including evaluation of joint swelling and tenderness; * Questionnaires about rheumatoid arthritis symptoms; * Computer-based exercise to assess preferences for various state-of-health choices; * Grip strength test; * Walking test on level ground, with or without the use of a cane or walker; * Blood test to measure inflammation. At the second visit, in addition to the above procedures, participants will complete a questionnaire to rate the importance of changes, if any, in pain, morning stiffness, fatigue, joint swelling, functioning, worry, depression, and overall impressions, since the first visit.

Key facts

Study ID
NCT00056602
Run by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
People needed
192
Starts
2003-03-18
Expected to finish
2019-12-23
Last updated by the study team
2020-01-06

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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