UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010205 |
|---|---|
| Receipt number | R000011951 |
| Scientific Title | Prediction of therapeutic efficacy of infliximab for refractory ulcerative colitis by analyzing and measuring serum concentration of cytokines and infliximab |
| Date of disclosure of the study information | 2013/03/10 |
| Last modified on | 2018/03/27 14:10:01 |
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Basic information
Public title
Prediction of therapeutic efficacy of infliximab for refractory ulcerative colitis by analyzing and measuring serum concentration of cytokines and infliximab
Acronym
Prediction of therapeutic efficacy of IFX for refractory UC by measuring serum cytokines and IFX
Scientific Title
Prediction of therapeutic efficacy of infliximab for refractory ulcerative colitis by analyzing and measuring serum concentration of cytokines and infliximab
Scientific Title:Acronym
Prediction of therapeutic efficacy of IFX for refractory UC by measuring serum cytokines and IFX
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a biomarker to predict the therapeutic efficacy of infliximab for refractory ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
To search a predicting factor for the efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between the clinical and endoscopic efficacy of infliximab for ulcerative colitis and the serum concentration of IL-6, TNF-alpha and IFX.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with refractory ulcerative colitis who are candidates for infliximab therapy.
Key exclusion criteria
Patients who refuse the induction infliximab therapy or those who don't agree with participating in this study after sufficient written explanation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadakazu Hisamatsu |
Organization
School of Medicine, Keio University
Division name
Division Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-5363-3790
hisamachi@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadakazu Hisamatsu |
Organization
School of Medicine, Keio University
Division name
Division Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-5363-3790
Homepage URL
hisamachi@a7.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Division Gastroenterology and Hepatology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Keio University
Division Gastroenterology and Hepatology, Department of Internal Medicine
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 10 | 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 | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Open public recruiting
Management information
Registered date
| 2013 | Year | 03 | Month | 10 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011951
