Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00056602 |
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:
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.
Condition |
---|
Rheumatoid Arthritis |
Study Type: | Observational |
Official Title: | Clinically Important Changes in Rheumatoid Arthritis |
Estimated Enrollment: | 300 |
Study Start Date: | March 2003 |
Proper interpretation of the results of clinical trials requires an assessment of not only the statistical significance of treatment differences but also the clinical importance of such differences. Efforts to define criteria for important improvement in rheumatoid arthritis (RA) activity have thus far not considered the patient's perspective. The aim of this project is to determine if criteria for important improvement in arthritis activity measures can be defined. This will be done by assessing the agreement among patients of judgments of important changes in arthritis activity. We will also determine if preference measures, which are a group of measures of the desirability of a particular state of health, can be used to assess when patients experience an important change in their arthritis.
This prospective longitudinal observational study will measure changes in 12 arthritis activity measures, changes in preference measures, and judgments of the importance of changes in arthritis activity over one to four months in 300 patients with active RA. Consensus among patients regarding the degree of change considered important would allow group criteria for important improvement to be defined that were based on patients' valuations.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Participants will be recruited by physician referral and self-referral.
Inclusion criteria will be:
EXCLUSION CRITERIA:
Exclusion criteria will be:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 030133, 03-AR-0133 |
Study First Received: | March 19, 2003 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00056602 |
Health Authority: | United States: Federal Government |
Utility Health Status Preferences Response Criteria |
Treatment Rheumatoid Arthritis RA |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |