ulcerative colitis
Conditions
Interventions
Additional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema
The continuation of concomitant treatment at
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: The patients with ulcerative colitis who were diagnosed according to the diagnostic criteria of the Research Committee on Inflammatory Bowel Disease in Japan 2: The patients with ulcerative colitis who were induced remission by the treatment of budesonide form enema (4 or more than 4 weeks)
Exclusion criteria
Exclusion criteria: 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 However, the patients who were administrated with stable dose more than 6 months or withdrawn more than 4 months before can be enrolled. 6: The patients who were changed the dosage of concomitant immunomodulator within 3 months prior to registration 7: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 However, the patients who were withdrawn for the topical 5-aminosalicylate (enema or suppository) at the registration can be enrolled. 10: The patients who were indicated the lesion (1 or more than 1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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steroid-free endoscopic mucosal healing at week 48 after randomized allocation | — |
Countries
Japan
Contacts
Public ContactKenji Watanabe
Hyogo College of Medicine Department of Intestinal Inflammation Research
Outcome results
None listed