Clinically Important Changes in Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-03-18

Study Completion Date

2019-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PREVALENCE OF Anti-CCP POSITIVITY AND SUBCLINICAL SIGNS OF INFLAMMATION IN PATIENTS WITH NEW ONSET OF NON-SPECIFIC MUSCULOSKELETAL SYMPTOMS

NCT03267147

Rheumatoid Arthritis

COMPLETED

Chronic Pain in Rheumatoid Arthritis

NCT05038553

Arthritis, Rheumatoid Pain

RECRUITING

Metabolome Analysis in Patients With Rheumatoid Arthritis

NCT02960958

RheumatoId Arthritis

UNKNOWN

Identifying Novel Biomarkers in Early Rheumatology Patients

NCT03843658

Rheumatologic Disorder

UNKNOWN

Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

NCT01476956

Rheumatoid Arthritis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Participants will be recruited by physician referral and self-referral.

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