UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024936 |
|---|---|
| Receipt number | R000028636 |
| Scientific Title | Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis |
| Date of disclosure of the study information | 2016/11/22 |
| Last modified on | 2017/11/15 19:59:05 |
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Basic information
Public title
Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis
Acronym
Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis
Scientific Title
Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis
Scientific Title:Acronym
Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was performed to assess efficacy, safety and trough levels change of anti TNF-alfa antibody of additional Calcineurin inhibitors therapy in active Ulcerative Colitis patients with anti TNF-alfa antibody.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
primary outcome is efficacy at 6 months.
Effective is partial Mayo score <3.
Key secondary outcomes
Base
Study type
Interventional
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 |
Interventions/Control_1
patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml.
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
| 16 | years-old | <= |
Age-upper limit
| 150 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patients were diagnosed as Ulcerative colitis.
2 pMayo above 2
3 Patients to obtain consent for this study.
4 Over 16years old.
5 Patients received anti TNF-alfa antibody.
Key exclusion criteria
1 Patients with severe Ulcerative colitis.
2 Patients with colitis except for Ulcerative colitis.
3 Patients with gastrointestinal obstruction.
4 Preoperation patients.
5 Patients with severe infection.
6 Patients with severe heart disease.
7 Patients with serum creatinine above 1.2.
8 Patients with serum total Bilirubin above 2.0, AST above 50, ALT above 50.
9 Patients with malignancy or history of malignancy.
10 Patients with neuropsychiatric disorder.
11 women who are or may be pregnant, nursing women and woman who desire to bear children.
12 Inappropriate patients by doctor's judgement.
13 Patients who received a part of other UC therapies.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Kanai |
Organization
Keio University
Division name
Gastroenterology and Hepatology
Zip code
Address
35 Shinano-machi, Shinjyu-ku , Tokyo
TEL
03-3353-1211
takagast@z2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Naganuma |
Organization
Keio University
Division name
Gastroenterology and Hepatology
Zip code
Address
35 Shinano-machi, Shinjyu-ku , Tokyo
TEL
03-3353-1211
Homepage URL
maknaganuma@gmail.com
Sponsor or person
Institute
Keio University Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Self founding
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
| 2016 | Year | 11 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 30 | 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
| 2016 | Year | 11 | Month | 21 | Day |
Last modified on
| 2017 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028636
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| Registered date | File name |
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| Registered date | File name |
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