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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009566
Receipt No. 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

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Basic information
Public title Randomized controlled study for patients with RA using 23-valent pneumococcal polysaccharide vaccine.
Acronym RA-PPV23
Scientific Title Randomized controlled study for patients with RA using 23-valent pneumococcal polysaccharide vaccine.
Scientific Title:Acronym RA-PPV23
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Medicine in general Clinical immunology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy of a 23-valent pneumococcal polysaccharide vaccine in RA patients at high risk of pneumonia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Pneumococcal pneumonia.
Pneumonia from all cases.
Invasive pneumococcal disease (IPD).
Key secondary outcomes Hospitalization for pneumonia.
Death from all cases.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Subcutaneous injection of 23-valent peumococcal polysaccharide vaccine (0.5ml) once.
Interventions/Control_2 Subcutaneous injection of 0.5ml of saline, once.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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.
Target sample size 1600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Migita
Organization National Hospital Organization(NHO) Nagasaki Medical Center
Division name Clinical Research Center
Zip code
Address 2-1001-1 Kubara, Omura, Nagasaki, 856-8562, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Migita
Organization National Hospital Organization(NHO) Nagasaki Medical Center
Division name Clinical Research Center
Zip code
Address 2-1001-1 Kubara, Omura, Nagasaki, 856-8562, Japan
TEL
Homepage URL
Email

Sponsor
Institute National Hospital Organization(NHO) Nagasaki Medical Center Clinical Research Center
Institute
Department

Funding Source
Organization National Hospital Organization(NHO) multi-center clinical studies for evidence-based medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 12 Month 17 Day
Last modified on
2012 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011223

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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