Ulcerative Colitis
Conditions
Interventions
None listed
Sponsors
Kobayashi Taku
Mochida Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participant who have given their written consent to participate in this study. 2) Participant must be 18 years or older. 3) Confirmed by investigator to have a diagnosis of moderately to severely active UC. 4) Participant who were previously untreated or failed treatment with biologics.* 5) Initiating or planning to initiate mirikizumab for UC in the next 60 days of treatment decision *Biologic failure is in the opinion of the investigator. If a participant failed a biologic and its biosimilar, it is counted as 1 biologic failure.
Exclusion criteria
Exclusion criteria: 1) Have a current diagnosis of Crohn's disease. 2) Current or planned participation in an interventional clinical trial for UC. 3) Cognitive incapacity and language barriers precluding adequate understanding or cooperation. 4) Employees of the institution to which the investigator and co-investigator belong and their family members. Family members are defined as the spouse, biological parents, relatives, siblings, and children of the investigator or co-investigator's institutional affiliate. 5) Any other conditions that the investigator deems inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who meet criteria for symptomatic remission after 52 weeks of therapy with mirikizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Baseline demographic characteristics. - Baseline clinical characteristics, including prior UC medications and baseline concomitant medications for UC - Proportion of participants remaining on mirikizumab at Weeks 12, 24, 36, 52, 64, 76, 88 and 104 after baseline - Proportion of participants remaining on mirikizumab at Week 52 without steroids in prior 12 weeks - Proportion of participants who meet symptomatic remission at Week 52 without steroids in prior 12 weeks - Proportion of participants who meet symptomatic remission at the end of induction therapy, including extended induction with miliquizumab - Proportion of participants who meet symptomatic remission at Week 52 and maintain it through Week 104 - Proportion of participants who meet symptomatic response at Week 52 - Proportion of participants who meet symptomatic response at Week 52, who then achieve symptomatic remission at Week 104 - Proportion of participants who achieve remission of rectal bleeding at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104 - Mean change of rectal bleeding from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104 - Proportion of participants who achieve remission of stool frequency at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104 - Mean change of stool frequency from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104 - Mean change of UNRS from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104 - Mean change of bowel urgency frequency from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104 - Mean change of nocturnal stool frequency from baseline at Weeks 4, 8, 12, 16, 20, 24, 52, 76, and 104 - Mean change of SIBDQ score from baseline at Weeks 12, 24, 52, 76, and 104 - Mean change of WPAI:UC score from baseline at Weeks 12, 24, 52, 76, and 104 - Proportion of participants who have symptomatic remission at Week 52 with prior treatment history of ustekinumab - Proportion of participants who meet criteria for drug adherence at Weeks 12, 24, 36, 52, 64, 76, 88 and 104 aft | — |
Contacts
Public ContactKeisuke Makihara
Mebix, Inc.
Outcome results
None listed