The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000034016
- Lead Sponsor
- Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 84
Not provided
1: The patients who are intolerant for mesalazine 2: The patients who were seemed to perform remission maintenance therapy by mesalazine enema at least 2 times per week during 48 weeks with stability 3: The patients who are difficult to perform 2 times total colonoscopy at the achievement of remission induction by budesonide form enema and week 48 4: The patients who are treated with only budesonide form enema at the randomization 5: The patients who had history of treatment with biologics or JAK inhibitor. However, the patients who were administrated with stable dose more than 6 months or withdrawn more than 4 months before can be enrolled. 6: The patients who were changed the dosage of concomitant immunomodulator within 3 months prior to registration 7: The patients who were changed the dosage of concomitant 5-aminosalicylate within 4 weeks prior to registration 8: The patients who were administrated steroid except budesonide form enema within 4 weeks prior to registration 9: The patients who are treated with topical 5-aminosalicylate (enema or suppository) at the registration. However, the patients who were withdrawn for the topical 5-aminosalicylate (enema or suppository) at the registration can be enrolled. 10: The patients who were indicated the lesion (1 or more than 1 of Mayo endoscopic subscore) at the proximal to splenic flexure by total colonoscopy after remission induction by budesonide form enema. 11: The patients who are treated with cytapheresis 12: The patients who were judged as unsuitable participant for registration of this study by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Steroid-free endoscopic mucosal healing at week 48 after randomized allocation
- Secondary Outcome Measures
Name Time Method