UMIN-CTR Clinical Trial

Basic information
Public title	Clinical factor for clinicians to choose treatments to refractory ulcerative colitis patients, and the validity of the treatment.
Acronym	Clinical factor to choose treatments to refractory ulcerative colitis patients, and the validity of it.
Scientific Title	Clinical factor for clinicians to choose treatments to refractory ulcerative colitis patients, and the validity of the treatment.
Scientific Title:Acronym	Clinical factor to choose treatments to refractory ulcerative colitis patients, and the validity of it.
Region	Japan

Condition
Condition	refractory ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze clinical factors for clinicians to choose treatments to refractory ulcerative colitis. To analyze the validity of each treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient's clinical factors which influences choice of their treatments efficacy ratio and non-recurrence rate of each treatment
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	16 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Ulcerative colitis patient with steroid-dependent or steroid-resistant
Key exclusion criteria	1.Patients who became observation impossible within 52 weeks after treatment starting 2. Patients whose treatment deviate from health insurance 3. The patient who are judged unsuitable by the researcher.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Fuminao Middle name Last name Takeshima
Organization	Nagasaki university graduate school of Biomedecal Science
Division name	Department of Gastroenterology and hepatology
Zip code	852-8501
Address	1-7-1 Sakamoto Nagasaki-shi Nagasaki-ken Japan
TEL	095-819-7481
Email	ftake@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Fuminao Middle name Last name Takeshima
Organization	Nagasaki university graduate school of Biomedecal Science
Division name	Department of Gastroenterology and hepatology
Zip code	852-8501
Address	1-7-1 Sakamoto Nagasaki-shi Nagasaki-ken Japa
TEL	095-819-7481
Homepage URL
Email	ftake@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki university graduate school of Biomedecal Science Department of Gastroenterology and hepatology
Institute
Department

Funding Source
Organization	Nagasaki university graduate school of Biomedecal Science Department of Gastroenterology and hepatology
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	Nagasaki university graduate school of Biomedecal Science, Department of Gastroenterology and hepatology
Address	1-7-1 Sakamoto Nagasaki-shi Nagasaki-ken Japan
Tel	095-819-7481
Email	takeshima-ngs@umin.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	2016 Year 12 Month 15 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7385627/
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7385627/
Number of participants that the trial has enrolled	150
Results	The clinical response rates at 8 weeks were 74.0% in total, and 73.2% and 74.7% in the anti-TNF and TAC groups. Among the total cases, male sex was responded to the treatment. In the TAC group, high CRP increased the odds of treatment response. The male sex increased the odds of effectiveness only in the TNF group. TAC rather than anti-TNF therapy was an independent risk factor for relapse. A higher Mayo score at 8 weeks also significantly increased the risk for relapse in all cases.
Results date posted	2021 Year 03 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	A total of 150 cases were analyzed. Seventy-one individuals were treated with anti-TNF agents, and 79 individuals received TAC. The mean age was 46.2 years, 51.3% were men, the mean disease duration was 90.8 months, and 64.7% had total colitis. The proportion of patients with total colitis, rate of hospitalization, cytomegalovirus (CMV) infection, pMS, MES, and baseline CRP level tended to be higher in the TAC group. In the anti-TNF group, 30 and 41 were treated by IFX and ADA. Most of the patients in the IFX group were hospitalized (96.7%), only 61% were hospitalized in the ADA group. The pMS and MES tended to be higher in the IFX than in the ADA group.
Participant flow	This was a multicentre retrospective observational study of steroid-refractory UC patients receiving anti-TNF agents or TAC between March 2010 and March 2017. A total of eight medical sites including Nagasaki University Hospital and its related facilities were involved. Data collected at baseline included gender, age, disease duration, disease extension, concomitant medications, CRP level, partial Mayo score (pMS), and Mayo endoscopic score (MES). The date of and reason for treatment discontinuation, requirement for further rescue therapy, and any adverse events were also recorded. At week 12, TAC was discontinued.
Adverse events	IFX was withdrawn in five patients, including three females with infusion reaction, a male with seroconversion of the interferon-gamma release assay, and another male with pneumocystis pneumonia. ADA was withdrawn in one female patient who experienced skin eruption. TAC was withdrawn in three patients, including two cases with leukocytopenia (one female and one male) and one male with renal dysfunction. No deaths occurred during the study period.
Outcome measures	The primary endpoints of the study were rates of clinical remission and response at 8 weeks. The secondary endpoints were cumulative relapse-free rates. Long-term outcomes were evaluated using data from patients who were followed up for more than 6 months after IFX, ADA, or TAC treatment.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 01 Day
Date of IRB	2016 Year 12 Month 19 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	severity of ulcerative colitis C7HRP remission induction treatment if necessary, next treatment and its efficacy

Management information
Registered date	2016 Year 12 Month 14 Day
Last modified on	2021 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028987