Unique ID issued by UMIN | UMIN000009566 |
---|---|
Receipt number | R000011223 |
Scientific Title | Randomized controlled study for patients with RA using 23-valent pneumococcal polysaccharide vaccine. |
Date of disclosure of the study information | 2012/12/20 |
Last modified on | 2012/12/17 16:21:37 |
Randomized controlled study for patients with RA using 23-valent pneumococcal polysaccharide vaccine.
RA-PPV23
Randomized controlled study for patients with RA using 23-valent pneumococcal polysaccharide vaccine.
RA-PPV23
Japan |
Rheumatoid arthritis
Medicine in general | Clinical immunology | Infectious disease |
Others
NO
To determine the efficacy of a 23-valent pneumococcal polysaccharide vaccine in RA patients at high risk of pneumonia.
Efficacy
Confirmatory
Explanatory
Phase IV
Pneumococcal pneumonia.
Pneumonia from all cases.
Invasive pneumococcal disease (IPD).
Hospitalization for pneumonia.
Death from all cases.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Vaccine |
Subcutaneous injection of 23-valent peumococcal polysaccharide vaccine (0.5ml) once.
Subcutaneous injection of 0.5ml of saline, once.
16 | years-old | < |
Not applicable |
Male and Female
Patients with rheumatoid arthritis who regularly visited a facility of the National Hospital Organization (NHO) and met any of the following 5 criteria:
1, Undergoing treatment with a biological drug
2, Having an existing pulmonary disease (RA pulmonary lesion, COPD, old pulmonary tuberculosis or atypical pulmonary mycobacteriosis)
3, Undergoing treatment with steroid (5 mg/day or more when converted to prednisolone)
4, Undergoing treatment with immunosuppressive drugs (including low-molecular compounds) other than MTX
5, Classified as the Steinbrocker stage 3 or 4
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.
1600
1st name | |
Middle name | |
Last name | Kiyoshi Migita |
National Hospital Organization(NHO) Nagasaki Medical Center
Clinical Research Center
2-1001-1 Kubara, Omura, Nagasaki, 856-8562, Japan
1st name | |
Middle name | |
Last name | Kiyoshi Migita |
National Hospital Organization(NHO) Nagasaki Medical Center
Clinical Research Center
2-1001-1 Kubara, Omura, Nagasaki, 856-8562, Japan
National Hospital Organization(NHO) Nagasaki Medical Center Clinical Research Center
National Hospital Organization(NHO) multi-center clinical studies for evidence-based medicine
Japan
NO
2012 | Year | 12 | Month | 20 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 10 | Month | 21 | Day |
2012 | Year | 11 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2012 | Year | 12 | Month | 17 | Day |
2012 | Year | 12 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011223