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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008043
Receipt No. R000008785
Scientific Title The influence of medication for Crohn's disease on serological response to the influenza vaccination
Date of disclosure of the study information 2012/05/28
Last modified on 2019/06/23

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Basic information
Public title The influence of medication for Crohn's disease on serological response to the influenza vaccination
Acronym Influence of Crohn's disease medication on influenza vaccination
Scientific Title The influence of medication for Crohn's disease on serological response to the influenza vaccination
Scientific Title:Acronym Influence of Crohn's disease medication on influenza vaccination
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of Crohn's disease-medications on the serological response to the influenza vaccine
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Response Rate of post-vaccination antibody titters against Influenza B/Brisbane.
Key secondary outcomes 1;Response Rate of post-vaccination antibody titters against Influenza A/California,Victoria.
2; CDAI scores at each observation period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine Vaccine
Interventions/Control_1 Influenza Vaccination to Crohn's disease patients treated with Infliximab
Interventions/Control_2 Influenza Vaccination to Crohn's disease patients treated with Elemental diet
Interventions/Control_3 Influenza Vaccination to patients with upper-alimentary tract disorders (Disease-control)
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients of Crohn's disease
with Infliximab treatments or elemental diet therapy (>1 year) who want to receive Influenza vaccination
2)Patients of upper alimentary tract disorders without crohn's disease and ulcerative colitis who have not been treated with steroid, immunomodulators, anti-TNF reagents, and elemental diet within 16weeks.(Disease Control)
Key exclusion criteria 1)Patients who have been treated with Cyclosporin, Tacrolimus, Methotrexate, Steroids, total parental nutrition,granulocyte/monocyte apheresis therapy within 16 weeks.
2) Patients with severe infection or its complications within 1 year.
3) Patients with severe heart, kidney,liver,blood disease or developmental disorders.
4) Patients with allergic disease (Generalized rash etc.)
5) Patients with history of convulsion.
6) Patients diagnosed as an immune deficiency.
7) Patients with respiratory disease (interstitial pneumonia, bronchial asthma etc.)
8) Patients with allergy against ingredients of Influenza vaccine, hen's egg,or ingredients of hen.
9) Patients with drug or alcohol dependence or its history
10) Patients participated other clinical trial within 16 weeks.
11)Other patients judged as inappropriate bu the physician.
12) Patients received anti-TNF agents within 1 year (Only Elemental diet Groups)
13) Patients do not desire to receive Influenza vaccination.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Saruta
Organization The Jikei University School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Saruta
Organization The Jikei University School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email

Sponsor
Institute The Jikei University School of Medicine
Division of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 東京慈恵会医科大学(東京都)、昭和大学(東京都)虎ノ門病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 28 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 Terminated
Date of protocol fixation
2012 Year 02 Month 06 Day
Date of IRB
2011 Year 12 Month 09 Day
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 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 05 Month 28 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008785

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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