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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035842
Receipt No. R000040829
Official scientific title of the study Patients' and doctors' assessment of adalimumab self injection: a multicenter questionnaire survey- Pearl survey 2
Date of disclosure of the study information 2019/02/12
Last modified on 2019/02/12

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Basic information
Official scientific title of the study Patients' and doctors' assessment of adalimumab self injection: a multicenter questionnaire survey- Pearl survey 2
Title of the study (Brief title) Assessment of adalimumab self injection in the patients and doctors
Region
Japan

Condition
Condition Crohn's disease, Ulcerative colitis and intestinal Behchet 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 IBD patients by Questionnaire in patients and doctors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Satisfaction rate of adalimumab self injection for pen type
Key secondary outcomes Pain of adalimumab self injection.
Adherence of adalimumab self injection.
Anxiety of adalimumab self injection.
Difference in recognition of adalimumab self-injection among patients - doctors
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 IBD (inflammatory bowel 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 300

Research contact person
Name of lead principal investigator Noriko Kamata
Organization Osaka City University
Division name Department of Gastroenterology
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 0666453811
Email nkamata@med.osaka-cu.ac.jp

Public contact
Name of contact person Noriko Kamata
Organization Osaka City University
Division name Department of Gastroenterology
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 0666453811
Homepage URL
Email nkamata@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
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)

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 大阪市立大学(大阪)、福岡大学筑紫病院(福岡)、兵庫医科大学(兵庫)、岩手医大(岩手)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 12 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 27 Day
Anticipated trial start date
2018 Year 12 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Subject:IBD patients who under treatment of adalimumab self injection
Target sample size:300
Method:Questionaire for patients and doctors
Contents:Assesment of efficacy and problems of adalimumab self injection.
Number of institusion:4 institusions

Management information
Registered date
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040829

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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