UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036506 |
|---|---|
| Receipt number | 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 | 2022/10/21 21:21:33 |
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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
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
mimari77@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University, Department of Gastroenterology.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041592
