Protocol Number: 03-AR-0133

Title:

Clinically Important Changes in Rheumatoid Arthritis

Number:

03-AR-0133

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.

Sponsoring Institute:

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

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

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. English literacy;

5. Active arthritis, as evidence by six or more tender joints.

EXCLUSION CRITERIA:

Exclusion criteria will be:

1. Inability to provide informed consent.

2. Children will necessarily be excluded from this protocol.

Special Instructions: Currently Not Provided

Keywords:

Utility

Health Status

Preferences

Response Criteria

Treatment

Recruitment Keywords:

Rheumatoid Arthritis

RA

Conditions:

Rheumatoid Arthritis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Paulus HE, Egger MJ, Ward JR, Williams HJ. Analysis of improvement in individual rheumatoid arthritis patients treated with disease-modifying antirheumatic drugs, based on the findings in patients treated with placebo. The Cooperative Systematic Studies of Rheumatic Diseases Group. Arthritis Rheum. 1990 Apr;33(4):477-84. PMID: 2109613

van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria.

Arthritis Rheum. 1996 Jan;39(1):34-40. PMID: 8546736

Ward MM. Response criteria and criteria for clinically important improvement: separate and equal? Arthritis Rheum. 2001 Aug;44(8):1728-9. No abstract available. PMID: 11508421

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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Bethesda, Maryland 20892. Last update: 10/26/2004