Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056602
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2003-03-19
Brief Title:
Clinically Important Changes in Rheumatoid Arthritis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinically Important Changes in Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-AR-0133 | None | None | None |