Randomized controlled study for patients with RA using 23-valent pneumococcal polysaccharide vaccine.
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000009566
- Lead Sponsor
- ational Hospital Organization(NHO) Nagasaki Medical Center Clinical Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1600
Not provided
1, Patients who received vaccination with pneumococcal vaccine during last 5 years. 2, Patients who concomitantly developed other autoimmune diseases (excluding Sjogren's syndrome) . 3, Patients who concomitantly developed a malignant tumor (excluding those who were cured for 5 years or longer) . 4, Patients who developed fever within 2 days after a past vaccination and those who developed generalized rash and other symptoms, which were suspected to be allergic symptoms. 5, Patients with a history of seizure. 6, Patients who were diagnosed as having immunological deficiency in the past and those who had relatives with congenital immunodeficiency. 7, Pregnant women, women suspected of being pregnant, and lactating women were excluded, because the safety of the vaccination in pregnant women had not been established. 8, Other patients who were judged to be inappropriate for the study by the primary physician due to unstable clinical conditions caused by serious complications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pneumococcal pneumonia. Pneumonia from all cases. Invasive pneumococcal disease (IPD).
- Secondary Outcome Measures
Name Time Method Hospitalization for pneumonia. Death from all cases.