UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010405 |
|---|---|
| Receipt number | R000012173 |
| Scientific Title | Study of the antibody titer by Influenza vaccination in Rheumatoid Arthritis patients treated with MTX and Biological agents |
| Date of disclosure of the study information | 2013/04/02 |
| Last modified on | 2013/04/02 22:54:45 |
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Basic information
Public title
Study of the antibody titer by Influenza vaccination in Rheumatoid Arthritis patients treated with MTX and Biological agents
Acronym
Influenza Biologics Study
Scientific Title
Study of the antibody titer by Influenza vaccination in Rheumatoid Arthritis patients treated with MTX and Biological agents
Scientific Title:Acronym
Influenza Biologics Study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Infectious disease | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is the study to compare antibody titers change after influenza vaccination for rheumatoid arthritis (RA) patients who have been treat with methotrexate
Basic objectives2
Others
Basic objectives -Others
The study to compare antibody titers change after influenza vaccination for rheumatoid arthritis (RA) patients who have been treat with methotrexate.
In the group of biological agents was carried out twice influenza vaccination, to examine its effects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects on influenza antibody titer of MTX and biological agents in Japan
Seropositive rate
Seroconversion rate
Change antibody rate
Key secondary outcomes
Correlation between antibody titer and disease activity flu vaccine safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The patients with rheumatoid arthritis
2.Class 1 to 3 degree of patients dysfunction
3.The patients used Prednisolone under 10mg
4.The patients over 20 years old
5.The patients by whom consent is got in written from about participation of the final examination
Key exclusion criteria
None
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisato. Ishikawa |
Organization
Nagoya Medical Center, National Hospital Organization in JAPAN
Division name
Department of Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1 Sannomaru,Nakaku Nagoya Aichi 460-0001, JAPAN
TEL
052-951-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisato. Ishikawa |
Organization
Nagoya Medical Center, National Hospital Organization in JAPAN
Division name
Department of Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1 Sannomaru,Nakaku Nagoya Aichi 460-0001, JAPAN
TEL
052-951-1111
Homepage URL
hisi1973@nnh.hosp.go.jp
Sponsor or person
Institute
Nagoya Medical Center, National Hospital Organization in JAPAN
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 04 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
The study to compare antibody titers change after influenza vaccination for rheumatoid arthritis (RA) patients who have been treat with methotrexate.
In the group of biological agents was carried out twice influenza vaccination, to examine its effects.
Management information
Registered date
| 2013 | Year | 04 | Month | 02 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012173
