UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009664 |
|---|---|
| Receipt number | R000011238 |
| Scientific Title | The Predictive Factors for Refractory Status and Readmission after Tacrolimus Treatment in Patients with Active Ulcerative Colitis |
| Date of disclosure of the study information | 2012/12/29 |
| Last modified on | 2014/07/08 19:48:23 |
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Basic information
Public title
The Predictive Factors for Refractory Status and Readmission after Tacrolimus Treatment in Patients with Active Ulcerative Colitis
Acronym
The Predictive Factors for Refractory Status and Readmission after Tacrolimus Treatment in Patients with Active Ulcerative Colitis
Scientific Title
The Predictive Factors for Refractory Status and Readmission after Tacrolimus Treatment in Patients with Active Ulcerative Colitis
Scientific Title:Acronym
The Predictive Factors for Refractory Status and Readmission after Tacrolimus Treatment in Patients with Active Ulcerative Colitis
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate the predictors for refractory to Tacrolimus and readmission after Tacrolimus therapy in patients with active UC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The predictors for refractory to Tacrolimus
The predictors for readmission after Tacrolimus therapy
*Refractory tacrolimus is defined a patient who underwent surgery or changed to alternative treatment during TAC therapy with high trough level (10-15ng/ml, at least 7 days)
*Relapse is defined as UC-related readmission within 6 months after Tacrolimus therapy
Key secondary outcomes
1.The cumulative colectomy-free survival over 6 months
2.Duration of maintaining as the state of non-relapsing*
*State of non-relapse is defined by Lichtiger's clinical activity index (CAI) score: Total score<=3
3.State of mucosal healing defined by elements of endoscopic findings in Mayo score
4.Ratio of patients who can achieve steroid withdrawal and the duration for steroid withdrawal
5.Decrease of concentration of C-reactive protein as an inflammatory marker
6.Overall safety during maintenance therpy
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria
Patients who meets all criteria 1 and 2.
1. Patients with moderate to severe active disease
Lichtiger's clinical activity index (CAI) >= 9
2.Eligible patients were aged 20 to 65 years old
Key exclusion criteria
Exclusion criteria
1.Patients with serious infectious disease
2.Patients with serious heart disease
3.Patients with serious kidney disease
4.Patients with serious liver disease
5.Patients with diabetes
6.Patients who are pregnant or have the possibility of pregnancy
7.Patients with malignancy
8.Patients who had adverse effect and/or high risk in administration thiopurine
9.Patients who judged as "non-eligible" for this study by responsible doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakamura Shiro |
Organization
Hyogo College of Medicine
Division name
Internal Medicine, Lower Gastroenterology
Zip code
Address
663-8501 1-1 Mukogawa-cho Nishinomiya-city Hyogo
TEL
0798-45-6662
shiro@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Yokoyama |
Organization
Hyogo College of Medicine
Division name
Internal Medicine, Lower Gastroenterology
Zip code
Address
663-8501 1-1 Mukogawa-cho Nishinomiya-city Hyogo
TEL
0798-45-6662
Homepage URL
yoko0502@hyo-med.ac.jp
Sponsor or person
Institute
Internal Medicine, Lower Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine, Internal Medicine, Lower Gastroenterology
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
兵庫医科大学 内科学 下部消化管科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2012 | Year | 12 | Month | 29 | Day |
Last modified on
| 2014 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011238
