UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025277 |
|---|---|
| Receipt number | R000028987 |
| Scientific Title | Clinical factor for clinicians to choose treatments to refractory ulcerative colitis patients, and the validity of the treatment. |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2021/03/13 01:32:56 |
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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
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
ftake@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university graduate school of Biomedecal Science
Department of Gastroenterology and hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028987
