Persistence and safety of Mirikizumab in patients with active ulcerative colitis

Persistence and safety of Mirikizumab in patients with active ulcerative colitis - Miracle C study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053952

Enrollment

Registered

2024-06-01

Start date

2024-05-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with active ulcerative colitis treated with mirikizumab

Exclusion criteria

Exclusion criteria: Patients without informed consent Patients inappropriate for this study Patients experienced mirikizumab treatment Patients performed colectomy Patinet who are pregnant or breastfeeding Patients undergoing cancer treatment

Design outcomes

Primary

Measure	Time frame
Persistence rate of mirikizumab at week 40	—

Secondary

Measure	Time frame
1. Clinical response rate at week 4,8,12,16,20,24,32,36,40 2. Clinical remission rate at week 4,8,12,16,20,24,32,36,40 3. Steroid-free clinical remission rate at week 4,8,12,16,20,24,32,36,40 4. Bowel urgency (BU) response rate at week 4,8,12,16,20,24,32,36,40 5. Bowel urgency (BU) remission rate at week 4,8,12,16,20,24,32,36,40 6. Normalization rate of fecal calptotectin (FC) at week 4,8,12,16,20,24,32,36,40 7. Normalization rate of fecal immunochemical test (FIT) at week 4,8,12,16,20,24,32,36,40 8. Time-course changes of CRP, LRG, FIT, BU score at every visits 9. Endoscopic remission rate at week 0, 40 10. Endoscopic Mayo score at week 0, 40 11. Treatment effects of second- and third-line treatments 12. Time-course changes of mirikizumab (MKB), anti-MKB antibody and concentrations of cytokines, chemokines and soluble adhesion molecules 13. Time-course changes of mRNA of cytokines, chemokines, adhesion molecules and their receptors 14. Safety profile of the patients treated with MKB	—

Measure

Time frame

1. Clinical response rate at week 4,8,12,16,20,24,32,36,40 2. Clinical remission rate at week 4,8,12,16,20,24,32,36,40 3. Steroid-free clinical remission rate at week 4,8,12,16,20,24,32,36,40 4. Bowel urgency (BU) response rate at week 4,8,12,16,20,24,32,36,40 5. Bowel urgency (BU) remission rate at week 4,8,12,16,20,24,32,36,40 6. Normalization rate of fecal calptotectin (FC) at week 4,8,12,16,20,24,32,36,40 7. Normalization rate of fecal immunochemical test (FIT) at week 4,8,12,16,20,24,32,36,40 8. Time-course changes of CRP, LRG, FIT, BU score at every visits 9. Endoscopic remission rate at week 0, 40 10. Endoscopic Mayo score at week 0, 40 11. Treatment effects of second- and third-line treatments 12. Time-course changes of mirikizumab (MKB), anti-MKB antibody and concentrations of cytokines, chemokines and soluble adhesion molecules 13. Time-course changes of mRNA of cytokines, chemokines, adhesion molecules and their receptors 14. Safety profile of the patients treated with MKB

—

Countries

Japan

Contacts

Public ContactSHINGO KATO

Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology

skato@saitama-med.ac.jp049-228-3654

Outcome results