UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043883 |
|---|---|
| Receipt number | R000050106 |
| Scientific Title | The study of anti-neutrophil cytoplasmic antibody(ANCA) for efficacy of biologics therapy in patients with ulcerative colitis |
| Date of disclosure of the study information | 2021/04/10 |
| Last modified on | 2021/04/18 12:27:17 |
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Basic information
Public title
The study of ANCA for efficacy of biologics therapy in patients with ulcerative colitis
Acronym
The study of ANCA
Scientific Title
The study of anti-neutrophil cytoplasmic antibody(ANCA) for efficacy of biologics therapy in patients with ulcerative colitis
Scientific Title:Acronym
The study of ANCA for efficacy of biologics therapy in patients with 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 this study was to examine whether PR3-ANCA and MPO-ANCA can predict efficacy to biologics in UC patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is proportion of patients with primary non-response to biologics stratified by PR3-ANCA and MPO-ANCA positivity.
Key secondary outcomes
The secondary outcome of this study is proportion of patients with loss of response to biologics stratified by PR3-ANCA and MPO-ANCA positivity.
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
(1) UC patients who plan to receive biologics
(2) Persons who have obtained written consent to participate in the research
(3) Gender does not matter
(4) Persons who are 16 years of age or older at the time of obtaining consent
Key exclusion criteria
(1) Persons who did not obtain consent after the explanation
(2) Those who cannot get an understanding by explaining it verbally
(3) Persons who have already been administered biopharmacy at the time of obtaining consent
(4) Partial Mayo score 2 points or less
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | atsushi |
| Middle name | |
| Last name | yoshida |
Organization
Ofuna Chuo Hospital
Division name
Center for Gastroenterology and Inflammatory Bowel Disease
Zip code
247-0056
Address
Ofuna 6-2-24, Kamakura, Kanagawa, Japan
TEL
0467-45-2111
atushi.y@kza.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | atsushi |
| Middle name | |
| Last name | yoshida |
Organization
Ofuna Chuo Hospital
Division name
Center for Gastroenterology and Inflammatory Bowel Disease
Zip code
247-0056
Address
Ofuna 6-2-24, Kamakura, Kanagawa, Japan
TEL
0467-45-2111
Homepage URL
atushi.y@kza.biglobe.ne.jp
Sponsor or person
Institute
Center for Gastroenterology and Inflammatory Bowel Disease, Ofuna Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants for research on intractable diseases from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ofuna Chuo Hospital
Address
Ofuna 6-2-24, Kamakura, Kanagawa, Japan
Tel
0467-45-2111
kenji-jimbo@ofunachuohp.net
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 | 04 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Mayo score on the biologic introduction date. And the Partial Mayo score on the biologic maintenance are shown at 0, 6-8 weeks, 14-16 weeks, and 48-56 weeks after the start of administration. In addition, PR3-ANCA and MPO-ANCA should be measured before the date of administration.
Management information
Registered date
| 2021 | Year | 04 | Month | 10 | Day |
Last modified on
| 2021 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050106
| 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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| Registered date | File name |
