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Clinically Important Changes in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00056602
Recruitment Status : Completed
First Posted : March 19, 2003
Last Update Posted : January 6, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

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.

Condition or disease
Rheumatoid Arthritis

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 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.

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Study Type : Observational
Actual Enrollment : 192 participants
Official Title: Clinically Important Changes in Rheumatoid Arthritis
Study Start Date : March 18, 2003
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : December 23, 2019

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 will be:

  1. Inability to provide informed consent.
  2. Children will necessarily be excluded from this protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00056602

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Michael M Ward, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Additional Information:
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Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Identifier: NCT00056602    
Other Study ID Numbers: 030133
First Posted: March 19, 2003    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ):
Health Status
Response Criteria
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases