NCT00056602

Clinically Important Changes in Rheumatoid Arthritis

Completed Last updated 6 January 2020

What this trial tests

trial in Rheumatoid Arthritis in 192 participants. Completed in 23 December 2019.

Timeline

18 March 2003

Primary endpoint
1 March 2018

23 December 2019

Quick facts

Lead sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	192
Start date	18 March 2003
Primary completion	1 March 2018
Estimated completion	23 December 2019
Sites	1 location across United States

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Who can join

Adults 18 to 100, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.