UMIN-CTR Clinical Trial

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	https://www.nature.com/articles/s41598-019-54369-7
Publication of results	Published

Result
URL related to results and publications	https://www.nature.com/articles/s41598-019-54369-7
Number of participants that the trial has enrolled	89
Results	A significantly higher remission maintenance rate was observed in the IM continuation group (p < 0.01). No significant difference was observed between the IM continuation group with a WBC of less than 3000 or a MCV of 100 or greater and the IM continuation group with a WBC of 3000 or greater and a MCV of 99 or lower (p = 0.08). Higher remission maintenance rates were observed in the IM continuation group of patients for whom MH had been achieved (p = 0.03).
Results date posted	2022 Year 10 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Subjects were 89 UC patients who were using IMs and for whom clinical remission had been maintained. Those with a Rachmilewitz Clinical Activity Index score of 4 or lower and those with a Mayo endoscopic subscore (MES) of 0 or 1 were defined as MH.
Participant flow	To select eligible patients, we retrospectively reviewed the medical records of 283 UC patients aged between 14 and 81 years who were treated at Dokkyo Medical University Hospital and Japanese Red Cross Ashikaga Hospital between April 2010 and March 2018. Of the 283 cases, a case where remission had not been achieved within 1 year of the oral administration of IMs and a case with a history of anti-TNF antibody agent administration were excluded.
Adverse events	None.
Outcome measures	The primary endpoint was the remission maintenance rate following IM withdrawal indicated by a MES of 0. Secondary endpoints were remission maintenance rates through continued IM administration, remission maintenance rates in an IM continuation group where MH had been achieved, and remission maintenance rates in an IM continuation group where adjustments were made.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 Year 10 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041592