UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis
Title of the study (Brief title)	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	Takanori Kanai
Organization	Keio University
Division name	Gastroenterology and Hepatology
Address	35 Shinano-machi, Shinjyu-ku , Tokyo
TEL	03-3353-1211
Email	takagast@z2.keio.jp

Public contact
Name of contact person	Makoto Naganuma
Organization	Keio University
Division name	Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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