UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031983 |
|---|---|
| Receipt number | R000036511 |
| Scientific Title | Examination of remission period in ulcerative colitis patients led to mucosal remission by induction therapy with budesonide rectal foam (AJG511) . |
| Date of disclosure of the study information | 2018/03/30 |
| Last modified on | 2019/09/08 20:21:48 |
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Basic information
Public title
Examination of remission period in ulcerative colitis patients led to mucosal remission by induction therapy with budesonide rectal foam (AJG511) .
Acronym
ESCORT Study
Scientific Title
Examination of remission period in ulcerative colitis patients led to mucosal remission by induction therapy with budesonide rectal foam (AJG511) .
Scientific Title:Acronym
ESCORT Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the remission period in mild to moderate ulcerative colitis patients who achieved clinical remission and mucosal remission with AJG511 therapy in clinical trials of AJG511 (phase II and III).
Basic objectives2
Others
Basic objectives -Others
Time to relapse in patients receiving standard maintenance therapy who achieved remission with AJG511 therapy will be determined.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to relapse after the end of AJG511 therapy
Key secondary outcomes
Time to relapse in patients with an endoscopic
findings score of 0 or 1
Time to relapse in patients receiving study treatment in the QD and BID groups
Time to relapse by disease type
Factors affecting relapse
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study includes ulcerative colitis patients receiving the active drug in clinical trials of AJG511 (phase II and III) and meeting all of the following three criteria at the end of the study treatment:
Rectal bleeding score is 0
Stool frequency score is 0 or has decreased by more than 0 (1 or more) point compared with Week 0
Endoscopic findings score is 0 or 1 (determined by the Colonoscopic Evaluation Central Review Panel)
Key exclusion criteria
The study excludes patients meeting any of the following criteria:
Patients who received the active drug in clinical trials of AJG511 (phase II and III) but have no endoscopic findings score assessed at the end of the study treatment
Any others considered ineligible for study participation by the investigator, etc.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Naganuma |
Organization
School of Medicine, Keio University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinano-machi, Shinjuku-ku , Tokyo
TEL
03-3353-1211
nagamakoto@keio.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Naganuma |
Organization
School of Medicine, Keio University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinano-machi, Shinjuku-ku , Tokyo
TEL
03-3353-1211
Homepage URL
nagamakoto@keio.jp
Sponsor or person
Institute
EA Pharma Co.,Ltd.
Kissei Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd.
Kissei Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院 他約30施設
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0220413
Number of participants that the trial has enrolled
60
Results
Eighteen of the 60 patients (30.0%) experienced no relapse during the 2-year follow-up period. The median relapse-free survival time was 0.82 years (95%CI: 0.51-1.52). Of 37 patients with a Mayo endoscopic subscore of 0 after inducing remission with budesonide foam, 25 (67.6%) relapsed within 2 years. Patients with a disease duration of <1 year experienced a worse clinical outcome than patients with a disease duration of >5 years, and the hazard ratio was 2.38 (95%CI: 1.04-5.45).
Results date posted
| 2019 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 05 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 24 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036511
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