UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043098 |
|---|---|
| Receipt number | R000049198 |
| Scientific Title | Study on Treatment of ulcerative colitis with infliximab originator and bio- Similar Targeting remission |
| Date of disclosure of the study information | 2021/01/22 |
| Last modified on | 2023/07/26 15:30:54 |
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Basic information
Public title
Study on Treatment of ulcerative colitis with infliximab originator and bio- Similar Targeting remission
Acronym
TRUST study
Scientific Title
Study on Treatment of ulcerative colitis with infliximab originator and bio- Similar Targeting remission
Scientific Title:Acronym
TRUST study
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospectively observe the short-term and long-term efficacy and safety of Infliximab, Biosimilar(BS)1 and BS2 in patients with ulcerative colitis who received each antibody, and analyze factors that influence their effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission rate 30 weeks after the start of administration in the IFX / BS1 / BS2 groups
Key secondary outcomes
1) Remission rate, treatment continuation rate, surgery rate after 2 weeks, 6 weeks, 14 weeks, 22 weeks and 30 weeks
2) Cumulative remission maintenance rate, treatment continuation rate, surgery rate (Kaplanmeier method)
3) Calculation of cross-reactivity of anti-drug antibody against IFX / BS1 / BS2 to other preparations
4) Incidence of adverse events and their contents, presence or absence of abnormal laboratory test values, etc.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age is 16 years or older at the time of obtaining informed consent
2. Partial Mayo (pMayo) score of 3 points or more before IFX / BS1 / BS2 administration
3. After receiving sufficient explanation for participating in this research, the informed consent of the research subject himself / herself has been obtained after sufficient understanding.
Key exclusion criteria
1. Patients for whom a definitive diagnosis of ulcerative colitis has not been obtained
2. Proctitis type patients
3. Patients who have been administered either IFX / BS1 / BS2 in the past
(However, cases in which treatment was discontinued after achieving remission by IFX / BS1 / BS2 treatment are excluded only when the same preparation is restarted due to relapse)
4. Patients who have been treated with adalimumab or golimumab in the past and have been primarily ineffective
5. Patients with a history of colectomy
6. Patients with or have a history of malignant disease
7. Patients with serious infectious diseases
8. Others who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takehiko |
| Middle name | |
| Last name | Katsurada |
Organization
Hokkaido University Hospital
Division name
Division of endoscopy
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Japan
TEL
011-706-7715
tkatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Katsurada |
Organization
Hokkaido University Hospital
Division name
Division of endoscopy
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Japan
TEL
011-706-7715
Homepage URL
tkatsu@med.hokudai.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2021 | Year | 01 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study (no invasive)
Management information
Registered date
| 2021 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049198
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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