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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024936
Receipt No. 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

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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
Email 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
Email maknaganuma@gmail.com

Sponsor
Institute Keio University Gastroenterology and Hepatology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028636

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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