Examination of remission period in ulcerative colitis patients led to mucosal remission by induction therapy with budesonide rectal foam (AJG511) .
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000031983
- Lead Sponsor
- EA Pharma Co.,Ltd. Kissei Pharmaceutical Co.,Ltd.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method