UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of biologic therapy (Anti-TNF) discontinuation in remitted ulcerative colitis patients and therapeutic optimization
Acronym	Gari-leo study
Scientific Title	Prospective observational study of biologic therapy (Anti-TNF) discontinuation in remitted ulcerative colitis patients and therapeutic optimization
Scientific Title:Acronym	Gari-leo study
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Medicine in general Gastroenterology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Relapse rates after the cessation of anti-TNF alpha antibody and clinical response rate after re-administration of anti-TNF alpha antibody
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relapse rates after the cessation of anti-TNF alpha antibody (partial Mayo scores(PMS) are 3 and over )
Key secondary outcomes	Clinical response rate after re-administration of anti-TNF alpha antibody (partial Mayo score less than 3 points, and 30% decrease of the baseline) Relapse rates after the cessation of anti-TNF alpha antibody (partial Mayo scores are 3 points and over ) in patieints with adalimumab and infliximab Clinical response rate after re-administration of anti-TNF alpha antibody (partial Mayo score less than 3 points, and 30% decrease of the baseline) in patieints with adalimumab and infliximab Biomarkers predicting the relapse after the cessation of anti-TNF alpha antibody

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	the cessation of anti-TNF alpha antibody
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	15 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients in clinical remission state (partial Mayo scores are 3 points and over ) with anti-TNF alpha antibody without steroid for more than 6 months and over.
Key exclusion criteria	Patients who cannot continue administration of anti-TNF alpha antibody such as; Patients with severe infection, patients with active tuberculosis, patients with hypersensitivity to anti-TNF alpha antibody, patients with demyelination diseases, such as multiple sclerosis, patients with congestive heart failure, patients with pregnancy, patients with lactation, patients without informed consent, patients who has malignancy and had been cured form malignancy, patients who experienced colectomy, and patients who has been determined not to be suitable to this study by doctors
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1981 Kamoda, Kawagoe City
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Shingo Kato
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1981 Kamoda, Kawagoe City
TEL	+81-49-228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical Center, Saitama Medical University
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

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 17 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	25
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	Completed
Date of protocol fixation	2013 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date	2013 Year 09 Month 05 Day
Last follow-up date	2018 Year 11 Month 30 Day
Date of closure to data entry	2018 Year 11 Month 30 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2013 Year 07 Month 16 Day
Last modified on	2019 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013125