UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy
Title of the study (Brief title)	Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study)
Region	Japan

Condition
Condition	Ulcerative Colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy and safety of maintenance therapy by azathioprine versus adalimumab after induction of tacrolimus
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of non-relapse rates (1 year) between azathioprine group and adalimumab group
Key secondary outcomes	Comparison of side-effect rates (1 year) between azathioprine group and adalimumab group Comparison of clinical remission rates (1 year) between azathioprine group and adalimumab group Comparison of endoscopic remission rates (1 year) between azathioprine group and adalimumab group

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Induce azathioprine and continue maintenance therapy by azathioprine
Interventions/Control_2	Induce adalimumab and continue maintenance therapy by adalimumab
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Moderate to severe ulcerative colitis patients who are refractory to steroid therapy No history of immunomodulator, anti-TNF drug or calcineurin inhibitor within 1 year
Key exclusion criteria	Patients who are contraindicated of tacrolimus, azathioprine or adalimumab Female patients who are in lactation or desire to bear children Patients less than 15 years old Patients who do not consent to the trial Patients who had malignancy Patients who had intestinal resection within 6 months Patients who are short-bowel syndrome Patients who are not appropriate to participate to the trial
Target sample size	53

Research contact person
Name of lead principal investigator	Yasuo Suzuki
Organization	Sakura Medical Center, Toho university
Division name	Inflammatory bowel disease (IBD) center
Address	564-1, Shimoshizu, Sakura, Chica
TEL	043-462-8811
Email	yasuo-suzuki@sakura.med.toho-u.ac.jp

Public contact
Name of contact person	Yasuo Suzuki
Organization	Sakura Medical Center, Toho university
Division name	Inflammatory bowel disease (IBD) center
Address	564-1, Shimoshizu, Sakura, Chica
TEL	043-462-8811
Homepage URL
Email	yasuo-suzuki@sakura.med.toho-u.ac.jp

Sponsor
Institute	Sakura Medical Center, Toho university
Institute
Department

Funding Source
Organization	Sakura Medical Center, Toho university
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 26 Day
Anticipated trial start date	2018 Year 02 Month 01 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	2018 Year 01 Month 25 Day
Last modified on	2018 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035381