UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012289 |
|---|---|
| Receipt number | R000014063 |
| Scientific Title | Examination of relation between infliximab blood concentration and the frequency of second failure and effect maintenance after the infliximab secession. |
| Date of disclosure of the study information | 2013/11/13 |
| Last modified on | 2023/05/23 14:42:40 |
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Basic information
Public title
Examination of relation between infliximab blood concentration and the frequency of second failure and effect maintenance after the infliximab secession.
Acronym
Examination of infliximab blood concentration.
Scientific Title
Examination of relation between infliximab blood concentration and the frequency of second failure and effect maintenance after the infliximab secession.
Scientific Title:Acronym
Examination of infliximab blood concentration.
Region
| Japan |
Condition
Condition
psoriasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of relation between infliximab blood concentration and the frequency of second failure and effect maintenance after the infliximab secession.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
achievement rate of PASI75
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Of this study after having received enough explanation on participating, a document agreement by the free will of the patient person is provided after enough understanding.
Key exclusion criteria
It is a patient with the infliximab treatment experience in the past.
The patient who judged that a study person in charge or an enforcement partaker was inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuruta |
Organization
Osaka city university medical school
Division name
department of dermatology
Zip code
545-8585
Address
Asahi-machi Abeno-ku 1-4-3
TEL
06-6645-3826
dtsuruta@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuruta |
Organization
Osaka city university medical school
Division name
department of dermatology
Zip code
545-8585
Address
Asahi-machi Abeno-ku 1-4-3
TEL
06-6645-3826
Homepage URL
dtsuruta@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka city university medical school
department of dermatology
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
Address
1-2-7 Asahimachi Abeno-ku Osaka
Tel
0666453457
ethics@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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 13 | 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
| 2013 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
measurement of the infliximab blood concentration.
Management information
Registered date
| 2013 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014063
