UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035842 |
|---|---|
| Receipt number | R000040829 |
| Scientific Title | 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 | 2021/02/15 15:24:23 |
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Basic information
Public title
Patients' and doctors' assessment of adalimumab self injection: a multicenter questionnaire survey- Pearl survey 2
Acronym
Assessment of adalimumab self injection in the patients and doctors
Scientific Title
Patients' and doctors' assessment of adalimumab self injection: a multicenter questionnaire survey- Pearl survey 2
Scientific Title:Acronym
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
| 1st name | Noriko |
| Middle name | |
| Last name | Kamata |
Organization
Osaka City University
Division name
Department of Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
0666453811
nkamata@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Kamata |
Organization
Osaka City University
Division name
Department of Gastroenterology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
0666453811
Homepage URL
nkamata@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Department of Gastroenterology
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
Tel
0666453797
nkamata@med.osaka-cu.ac.jp
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
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
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040829
