UMIN-CTR Clinical Trial

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

Rheumatoid arthritis

Classification by specialty

Medicine in general	Clinical immunology	Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Pneumococcal pneumonia.
Pneumonia from all cases.
Invasive pneumococcal disease (IPD).

Key secondary outcomes

Hospitalization for pneumonia.
Death from all cases.

Study type

Interventional

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

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

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

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

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

Institute

National Hospital Organization(NHO) Nagasaki Medical Center Clinical Research Center

Institute

Department

Personal name

Organization

National Hospital Organization(NHO) multi-center clinical studies for evidence-based medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

12

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

12

Month

17

Day

Last modified on

2012

Year

12

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011223