UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036506
Receipt No. R000041592
Scientific Title Optimization of Immunomodulators and Their Withdrawal After Achievement of Mucosal Healing in Long-term Maintenance of Quiescent Ulcerative Colitis
Date of disclosure of the study information 2019/04/14
Last modified on 2019/04/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Optimization of Immunomodulators and Their Withdrawal After Achievement of Mucosal Healing in Long-term Maintenance of Quiescent Ulcerative Colitis
Acronym Optimization of Immunomodulators and Their Withdrawal After Achievement of Mucosal Healing in Long-term Maintenance of Quiescent Ulcerative Colitis
Scientific Title Optimization of Immunomodulators and Their Withdrawal After Achievement of Mucosal Healing in Long-term Maintenance of Quiescent Ulcerative Colitis
Scientific Title:Acronym Optimization of Immunomodulators and Their Withdrawal After Achievement of Mucosal Healing in Long-term Maintenance of Quiescent Ulcerative Colitis
Region
Japan

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

Objectives
Narrative objectives1 The aim of the present study was to examine if mucosal healing, which is currently considered the goal of ulcerative colitis treatment, can be a rationale for immunomodulators withdrawal in ulcerative colitis cases where long-term remission has been achieved.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was the remission maintenance rate following immunomodulators withdrawal indicated by a Mayo endoscopic subscore of 0.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
10 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria To select eligible patients, we retrospectively reviewed the medical records of 283 ulcerative colitis patients aged between 10 and 85 years who were treated at Dokkyo Medical University Hospital and Japanese Red Cross Ashikaga Hospital between April 2010 and March 2018.
Key exclusion criteria Of the 283 cases, a case where remission had not been achieved within 1 year of the oral administration of immunomodulators, a case with a history of anti-TNF alfa antibody agent administration, a case with less than 80% adherence to immunomodulators were excluded.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Mimari
Middle name
Last name Kanazawa
Organization Dokkyo Medical University
Division name Gastroenterology
Zip code 321-0293
Address 880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL 0282-87-2147
Email mimari77@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Mimari
Middle name
Last name Kanazawa
Organization Dokkyo Medical University
Division name Gastroenterology
Zip code 321-0293
Address 880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL 0282-87-2147
Homepage URL
Email mimari77@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University, Department of Gastroenterology.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dokkyo Medical University
Address 880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
Tel 0282-87-2275
Email r-kenkyu@dokkyomed.ac.jp

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
2019 Year 04 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 89
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 No longer recruiting
Date of protocol fixation
2019 Year 04 Month 14 Day
Date of IRB
2019 Year 04 Month 14 Day
Anticipated trial start date
2019 Year 04 Month 14 Day
Last follow-up date
2019 Year 04 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 04 Month 14 Day
Last modified on
2019 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041592

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.