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NCT00056602 · ClinicalTrials.gov registry record
Clinically Important Changes in Rheumatoid Arthritis
A clinical trial, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- 192
- Enrollment target
NCT00056602: Completed study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT00056602 is a clinical trial that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 192 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00056602 has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- 192 participants
- Enrollment target
Study 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2003-03-18 |
| Est. Completion | 2019-12-23 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT00056602 record still lists
NCT00056602 is an observational study that tracks outcomes without assigning an intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00056602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00056602 about?
NCT00056602 is a clinical study titled "Clinically Important Changes in Rheumatoid Arthritis". 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, pai...
What is the current status of trial NCT00056602?
This trial is currently completed. The enrollment target is 192 participants. The study started on 2003-03-18. Estimated completion is 2019-12-23.
Who is sponsoring clinical trial NCT00056602?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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