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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000038737 |
Receipt No. | R000044167 |
Scientific Title | A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis |
Date of disclosure of the study information | 2019/12/01 |
Last modified on | 2019/11/29 |
Basic information | ||
Public title | A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis | |
Acronym | A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis | |
Scientific Title | A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis | |
Scientific Title:Acronym | A comparison of the effectiveness of medium to long term biologics in moderate to severe ulcerative colitis | |
Region |
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Condition | |||
Condition | ulcerative colitis | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Clarify the positioning of various biologics |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | The rates of remission maintenance rates at 52 weeks, clinical activity index (partial mayo score) 2 or less |
Key secondary outcomes | The rates of induction remission at 14 weeks, , clinical activity index (partial mayo score) 2 or less
The rates of maintenance rates at 104 weeks, , clinical activity index (partial mayo score) 2 or less colectomy-free rate at 52 weeks mucosal healing rate at 52 weeks, endoscopic mayo score 0 or 1 |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | moderate to severe ulcerative colitis receiving biologics | |||
Key exclusion criteria | severe infection
Patients who have undergone or consider abdominal surgery Patients who are considered ineligible |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Sakura medical center, Toho university | ||||||
Division name | interal medicine | ||||||
Zip code | 285-0841 | ||||||
Address | 564-1,Shimoshizu, Sakura, Chiba, Japan | ||||||
TEL | 0434628811 | ||||||
taro-dog@sakura.med.toho-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Sakura medical center, Toho university | ||||||
Division name | internal medicine | ||||||
Zip code | 285-0841 | ||||||
Address | 564-1,Shimoshizu, Sakura, Chiba, Japan | ||||||
TEL | 0434628811 | ||||||
Homepage URL | |||||||
taro-dog@sakura.med.toho-u.ac.jp |
Sponsor | |
Institute | Toho university |
Institute | |
Department |
Funding Source | |
Organization | none |
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 | Sakura medical center, Toho university |
Address | 564-1,Shimoshizu, Sakura, Chiba, Japan |
Tel | 0434628811 |
taro-dog@sakura.med.toho-u.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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Publication of academic societies |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044167 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |