UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006169 |
|---|---|
| Receipt number | R000007291 |
| Scientific Title | Analysis of the correlation between the blood concentration of infliximab and therapeutic effect for refractory ulcerative colitis |
| Date of disclosure of the study information | 2011/08/13 |
| Last modified on | 2015/08/19 00:16:08 |
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Basic information
Public title
Analysis of the correlation between the blood concentration of infliximab and therapeutic effect for refractory ulcerative colitis
Acronym
Analysis of the correlation between the blood concentration of IFX and therapeutic effect for refractory UC
Scientific Title
Analysis of the correlation between the blood concentration of infliximab and therapeutic effect for refractory ulcerative colitis
Scientific Title:Acronym
Analysis of the correlation between the blood concentration of IFX and therapeutic effect for refractory UC
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Finding factors for prediction of therapeutic effect of anti-TNF alpha antibody for refratory ulcerative colitis by analysing the correlation between the blood concentration of infliximab and clinical improvement
Basic objectives2
Others
Basic objectives -Others
Prediction of therapeutic effect
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between the blood concentration of infliximab and clinical improvement assesed by endoscopic findings and clinical symptoms
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
The objects are patients diagnosed with ulcerative colitis by the diagnostic criteria of Japanese Health, Labour and Welfare Ministry. The purpose and nature of this study are explained to each subject, and written informed comsent must be obtained.
Key exclusion criteria
Those patients who do not consent to this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadakazu Hisamatsu |
Organization
Keio University, School of Medicine
Department of Internal Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University, School of Medicine, Department of Internal Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Keio University, School of Medicine
Department of Internal Medicine
Division of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Keio University, School of Medicine
Department of Internal Medicine
Division of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | 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
| 2011 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
The blood is collected when the coloscopy is performed or infliximab is infused.
Management information
Registered date
| 2011 | Year | 08 | Month | 13 | Day |
Last modified on
| 2015 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007291
