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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007197
Receipt No. R000008475
Scientific Title Assessment of adalimumab self injection in Crohn's disease-Pearl survey
Date of disclosure of the study information 2012/02/01
Last modified on 2012/09/24

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Basic information
Public title Assessment of adalimumab self injection in Crohn's disease-Pearl survey
Acronym Assessment of adalimumab self injection
Scientific Title Assessment of adalimumab self injection in Crohn's disease-Pearl survey
Scientific Title:Acronym Assessment of adalimumab self injection
Region
Japan

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

Objectives
Narrative objectives1 To reveal benefit and problems of adalimumab self injection in Crohn's disease by Questionnaire for patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Satisfaction rate of adalimumab self injection.
Key secondary outcomes Pain of adalimumab self injection.
Adherence of adalimumab self injection.
Anxiety of adalimumab self injection.
Problems of adalimumab self injection.
etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Crohn's disease patients who under treatment of adalimumab self injection
Key exclusion criteria Patients who do not give consent to participate in the survey.
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Matsui
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1 Zokumyouin, Chikushino, Fukuoka Pref
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Fumihito Hirai
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email fuhirai@cis.fukuoka-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization None
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 福岡大学筑紫病院(福岡)、大阪市立大学(大阪)、兵庫医科大学(兵庫)、九州大学(福岡)


Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 01 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 Completed
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Subject:Crohn's disease patients who under treatment of adalimumab self injection
Target sample size:100
Method:Questionaire for patients
Contents:Assesment of efficacy and problems of adalimumab self injection.
Number of institusion:4 institusions

Management information
Registered date
2012 Year 02 Month 01 Day
Last modified on
2012 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008475

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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