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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011200
Receipt No. R000013125
Scientific Title Prospective observational study of biologic therapy (Anti-TNF) discontinuation in remitted ulcerative colitis patients and therapeutic optimization
Date of disclosure of the study information 2013/07/17
Last modified on 2019/03/24

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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
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
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

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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