Clinically Important Changes in Rheumatoid Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/17/2019 |
| Start Date: | March 18, 2003 |
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.
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.
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' evaluations.
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' evaluations.
- INCLUSION CRITERIA:
Participants will be recruited by physician referral and self-referral.
Inclusion criteria will be:
1. A diagnosis of RA;
2. Age 18 years or older;
3. Onset of arthritis after the age of 16 years;
4. Active arthritis, as evidenced by six or more tender joints
EXCLUSION CRITERIA:
Exclusion criteria will be:
1. Inability to provide informed consent.
2. Children will necessarily be excluded from this protocol.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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