UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008043 |
|---|---|
| Receipt number | 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 15:13:38 |
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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
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
Sponsor or person
Institute
The Jikei University School of Medicine
Division of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008785
