The study on the efficacy and safety of budesonide enteric-coated extended-release tablets in cases with insufficient response to oral 5-ASA formulations or in cases of relapse (The study on the efficacy and safety of budesonide enteric-coated extended-release tablets in cases with insufficient response to oral 5-ASA formulations or in cases of relapse(BETA-UC-J))

未提供0 个研究点目标入组 36 人开始时间: 待定最近更新: 2025年5月26日

试验速览

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•Patients for whom written consent was obtained prior to the study by the patient himself or herself
•Patients older than 18 years at the time of informed consent
•Active ulcerative colitis patients with a p-Mayo total score between 2 and 7, inclusive, at baseline (Week 0), and a rectal bleeding subscore of at least 1
•Patients who have been treated with the same oral formulation of 5-ASA for at least 4 weeks at the beginning of the observation period (Week 0)
•Patients who can continue treatment with the dosage and administration before the start of observation period, if they are using the restricted concomitant drugs specified in 5.5.1 at the start of the observation period (Week 0) for at least 4 weeks before the start of the observation period

•Patients with contraindications to budesonide enteric-coated extended-release tablets (see package insert)
•Patients using biological agents, JAK inhibitors, immunosuppressive agents (excluding azathioprine formulations), steroids (excluding budesonide enteric-coated extended-release tablets), budesonide rectal foam, and CAP therapy at the start of the observation period (Week 0)
•Other patients who are judged by researchers and others as inappropriate for the present study

The rates of symptomatic remission at Week 8/Final Assessment

The rates of clinical improvement at Week 4 and 8/final assessment(Week 4 and 8/final assessment)
Change from Week 0 in p-Mayo total score at Week 4 and 8/final assessment(Week 4 and 8/final assessment)
Change from Week 0 in rectal bleeding subscore at Week 4 and 8/Final Assessment(Week 4 and 8/Final Assessment)
Change from Week 0 in stool frequency subscore at Week 4 and 8/final assessment(Week 4 and 8/final assessment)
Change from Week 0 in abdominal pain score at Week 4 and 8/Final Assessment(Week 4 and 8/Final Assessment)
Change from Week 0 in urgency score from Week 0 at Week 4 and 8/Final Assessment(Week 4 and 8/Final Assessment)
Change from Week 0 in IBDQ at Week 8/Final Assessment(Week 8/Final Assessment)
Adherence at Week 4 and Week 8/Final Assessment (number of tablets taken during the observation period divided by days taken)(Week 4 and Week 8/Final Assessment)
Change from Week 0 in Biomarkers (CRPs, LRG, PGEMUM) at Weeks 4 and 8/Final Assessment(Weeks 4 and 8/Final Assessment)
Incidence of adverse events and adverse drug reactions
Multivariate analysis of background factors and evaluation of predictors of efficacy
The rates of symptomatic remission at Week 4(Week 4)
The rates of clinical remission at Week 4 and 8/final assessment(Week 4 and 8/final assessment)

发起方

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