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Tracking Information | |||||||||
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First Received Date † | March 19, 2003 | ||||||||
Last Updated Date | November 7, 2008 | ||||||||
Start Date † | March 2003 | ||||||||
Current Primary Outcome Measures † | |||||||||
Original Primary Outcome Measures † | |||||||||
Change History | Complete list of historical versions of study NCT00056602 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Clinically Important Changes in Rheumatoid Arthritis | ||||||||
Official Title † | Clinically Important Changes in Rheumatoid Arthritis | ||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | |||||||||
Study Type † | Observational | ||||||||
Study Design † | |||||||||
Condition † | Rheumatoid Arthritis | ||||||||
Intervention † | |||||||||
Study Arms / Comparison Groups | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 300 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † |
Participants will be recruited by physician referral and self-referral. Inclusion criteria will be:
EXCLUSION CRITERIA: Exclusion criteria will be:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00056602 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | 03-AR-0133 | ||||||||
Study Sponsor † | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
Collaborators †† | |||||||||
Investigators † | |||||||||
Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
Verification Date | October 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |