UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus
Title of the study (Brief title)	Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical remission rate
Key secondary outcomes	Endoscopic remission rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tacrolimus will be decreased gradually three months after it was administered.
Interventions/Control_2	Adalimumab will be administrated three months after tacrolimus was administered, and tacrolimus will be decreased gradually.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with ulcerative colitis treated with tacrolimus and achieved clinical remission at month 3. Patients who does not achieved mucosal healing by colonoscopy. Mucosal healing is defined as a Mayo endoscopic score of 0. Antibiotics naive patients
Key exclusion criteria	Patients who are applied to the medically contraindicated of adalimumab Patients who are determined to be inappropriate for administration of adalimumab by doctors
Target sample size	50

Research contact person
Name of lead principal investigator	Takuya Inoue
Organization	Osaka Medical College Hospital
Division name	2nd Department of Internal Medicine
Address	2-7, Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL	072-683-1221
Email	ureuretakuwan@yahoo.co.jp

Public contact
Name of contact person	Kazuki Kakimoto
Organization	Osaka Medical College Hospital
Division name	2nd Department of Internal Medicine
Address	2-7, Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	in2098@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	None
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	2014 Year 12 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 15 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	2014 Year 12 Month 10 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018481