Rheumatoid Arthritis Clinical Trial
Official title:
Clinically Important Changes in Rheumatoid Arthritis
Verified date | January 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 192 |
Est. completion date | December 23, 2019 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
- 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. Active arthritis, as evidenced 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
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. — View Citation
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. — View Citation
Ward MM. Response criteria and criteria for clinically important improvement: separate and equal? Arthritis Rheum. 2001 Aug;44(8):1728-9. — View Citation
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