UMIN-CTR Clinical Trial

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

refractory ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Patient's clinical factors which influences choice of their treatments
efficacy ratio and non-recurrence rate of each treatment

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

15

Day

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7385627/

Publication of results

Published

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

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 related information

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

Registered date

2016

Year

12

Month

14

Day

Last modified on

2021

Year

03

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028987