Examination of remission period in ulcerative colitis patients led to mucosal remission by induction therapy with budesonide rectal foam (AJG511) .

Examination of remission period in ulcerative colitis patients led to mucosal remission by induction therapy with budesonide rectal foam (AJG511) . - ESCORT Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031983

Enrollment

Registered

2018-03-30

Start date

2018-03-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Time to relapse after the end of AJG511 therapy	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMakoto Naganuma

School of Medicine, Keio University Division of Gastroenterology and Hepatology, Department of Internal Medicine

nagamakoto@keio.jp03-3353-1211

Outcome results