Unique ID issued by UMIN | UMIN000031983 |
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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 |
Examination of remission period in ulcerative colitis patients led to mucosal remission by induction therapy with budesonide rectal foam (AJG511) .
ESCORT Study
Examination of remission period in ulcerative colitis patients led to mucosal remission by induction therapy with budesonide rectal foam (AJG511) .
ESCORT Study
Japan |
Ulcerative colitis
Hepato-biliary-pancreatic medicine |
Others
NO
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).
Others
Time to relapse in patients receiving standard maintenance therapy who achieved remission with AJG511 therapy will be determined.
Others
Others
Not applicable
Time to relapse after the end of AJG511 therapy
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
Observational
Not applicable |
Not applicable |
Male and Female
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)
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.
84
1st name | Makoto |
Middle name | |
Last name | Naganuma |
School of Medicine, Keio University
Division of Gastroenterology and Hepatology, Department of Internal Medicine
1608582
35 Shinano-machi, Shinjuku-ku , Tokyo
03-3353-1211
nagamakoto@keio.jp
1st name | Makoto |
Middle name | |
Last name | Naganuma |
School of Medicine, Keio University
Division of Gastroenterology and Hepatology, Department of Internal Medicine
1608582
35 Shinano-machi, Shinjuku-ku , Tokyo
03-3353-1211
nagamakoto@keio.jp
EA Pharma Co.,Ltd.
Kissei Pharmaceutical Co.,Ltd.
EA Pharma Co.,Ltd.
Kissei Pharmaceutical Co.,Ltd.
Profit organization
Keio University School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo
0333531211
med-rinri-jimu@adst.keio.ac.jp
NO
慶應義塾大学病院 他約30施設
2018 | Year | 03 | Month | 30 | Day |
Published
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0220413
60
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).
2019 | Year | 09 | Month | 08 | Day |
2019 | Year | 08 | Month | 05 | Day |
Completed
2017 | Year | 11 | Month | 29 | Day |
2018 | Year | 03 | Month | 09 | Day |
2018 | Year | 03 | Month | 30 | Day |
2018 | Year | 11 | Month | 07 | Day |
2018 | Year | 11 | Month | 07 | Day |
2018 | Year | 11 | Month | 08 | Day |
2019 | Year | 01 | Month | 24 | Day |
observational study
2018 | Year | 03 | Month | 29 | Day |
2019 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036511
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