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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031983
Receipt No. 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

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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
Email 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
Email nagamakoto@keio.jp

Sponsor
Institute EA Pharma Co.,Ltd.
Kissei Pharmaceutical Co.,Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036511

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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