UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013033 |
|---|---|
| Receipt number | R000015211 |
| Scientific Title | Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2014/01/31 14:22:01 |
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Basic information
Public title
Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis.
Acronym
Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis
Scientific Title
Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis.
Scientific Title:Acronym
Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine a change of disease activity, the endoscope evidence in the early stage of the Infliximab administration for the moderate disease (steroid-dependent resistance) of ulcerative colitis, usefulness of marker "fecal calprotectin" for the colonoscope.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mayo score percent improvement 6-14 weeks after the administration.
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks)
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
1. The patients with steroid dependence, resistant ulcerative colitis moderate disease.(Mayo Score 6-10)
2. Being 20 years old or older
3, A document agreement by the free will of the patients person himself being obtained in the thing which understands it enough after having received enough explanation on participating of this study
Key exclusion criteria
1. The patients with serious infection (sepsis)
2. The patients with active tuberculosis
3. The patients with a history of sensitivity to protein(mouse type, a chimeric type, humanized antibody) derived from a mouse or ingredient of the Infliximab
4. The patients with a history of demyelinating diseases (Multiple sclerosis)
5. The patients with congestive heart failure
6. The patients that doctor attending judged an arrangement to this study to be inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Department of Internal Medicine,Juntendo University
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo,Bunkyo ward,Tokyo,Japan
TEL
0338133111
otaro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Department of Internal Medicine,Juntendo University
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo,Bunkyo ward,Tokyo,JapanTokyo Japan
TEL
03-3813-3111
Homepage URL
otaro@juntendo.ac.jp
Sponsor or person
Institute
Department of Internal Medicine,Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2014 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | 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
Management information
Registered date
| 2014 | Year | 01 | Month | 31 | Day |
Last modified on
| 2014 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015211
