UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053952 |
|---|---|
| Receipt number | R000061577 |
| Scientific Title | Persistence and safety of Mirikizumab in patients with active ulcerative colitis |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/09/23 17:19:41 |
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Basic information
Public title
Persistence and safety of Mirikizumab in patients with active ulcerative colitis
Acronym
Miracle C study
Scientific Title
Persistence and safety of Mirikizumab in patients with active ulcerative colitis
Scientific Title:Acronym
Miracle C study
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical effectiveness including persistency and safety of mirikizumab in patinets with active ulcerative colitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Persistence rate of mirikizumab at week 40
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with active ulcerative colitis treated with mirikizumab
Key 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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | SHINGO |
| Middle name | |
| Last name | KATO |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-8550
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | SHINGO |
| Middle name | |
| Last name | KATO |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-8550
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
049-228-3654
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical Center, IRB
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
Tel
049-228-3902
smcrinri@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center prospective cohort study
The aim of this study is to find out the predictors for the persistency of mirikizumab treatment for the patients with ulcerative colitis. Clinical efficacy and safety of mirikizumab treatment are also evaluated.
Management information
Registered date
| 2024 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061577
