UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043753 |
|---|---|
| Receipt number | R000049893 |
| Scientific Title | Symptom improvement of ulcerative colitis after an induction dose of ustekinumab in Japanese clinical practice, measured using patient-reported outcomes |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2023/05/29 10:57:26 |
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Basic information
Public title
Symptom improvement of ulcerative colitis after an induction dose of ustekinumab in Japanese clinical practice, measured using patient-reported outcomes
Acronym
Sirius study
Scientific Title
Symptom improvement of ulcerative colitis after an induction dose of ustekinumab in Japanese clinical practice, measured using patient-reported outcomes
Scientific Title:Acronym
Sirius study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to describe treatment response and treatment pattern in the real-world setting amongst patients with moderate to severe ulcerative colitis who are initiating ustekinumab in Japan.
Basic objectives2
Others
Basic objectives -Others
Description of treatment response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to describe the initial response to ustekinumab induction treatment for UC in Japan
Key secondary outcomes
to investigate the relationship between the treatment response obtained at 8 weeks and earlier indicators of response
to describe the ustekinumab treatment pattern for patients initiating ustekinumab for UC in Japan, in particular the dosing interval for maintenance therapy
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.male or female aged at least 16 years of age
2.must have a confirmed diagnosis of ulcerative colitis in accordance with local practice
3.has a current ulcerative colitis severity that is judged by the treating physician to be moderate to severe (being a partial Mayo score of 5 to 9, inclusive)
4.a decision has been made by the treating physician and the patient within routine clinical practice to commence treatment with ustekinumab, having been deemed to have an inadequate response to, or intolerant to, previous UC therapy
5.must sign an ICF allowing data collection and source data verification in accordance with local requirements. If the subject is 16 to 19, informed consent might be obtained from each study subject according to the regulation of institution/hospital and their legally acceptable representative must sign an ICF.
6.must be able to read, understand, and complete patient-reported outcome instruments, and intend to cooperate with completion of patient-reported outcome instruments using smartphone/tablet.
Key exclusion criteria
1.has ever previously received ustekinumab (including clinical trial use)
2. based on physician judgement has i) severe extensive colitis and is at imminent risk of colectomy OR ii) a stoma or history of a fistula OR iii) previously had extensive colonic resection (e.g., less than 30 cm of colon remaining) OR iv) current fulminant colitis OR v) currently hospitalized for worsening of UC-related symptoms (Not excluded if the reason for hospitalization is first dose of ustekinumab ).
3. are currently receiving, or have received within the past 3 months, systemic treatment with a biologic therapy for any other indication (e.g. Crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
4. received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point
5. currently enrolled in an interventional study or another Janssen-sponsored observational study (including post-marketing surveillance)
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Frances |
| Middle name | |
| Last name | Chang |
Organization
Janssen Pharmaceutical K.K
Division name
Medical Affairs Division
Zip code
101-0065
Address
3-5-2 nishikanda,chiyoda-ku Tokyo,Japan
TEL
03-4411-7700
FChang@ITS.JNJ.com
Public contact
Name of contact person
| 1st name | Katsumasa |
| Middle name | |
| Last name | Nagano |
Organization
Janssen Pharmaceutical K.K
Division name
Medical Affairs Division
Zip code
101-0065
Address
3-5-2 nishikanda,chiyoda-ku Tokyo,Japan
TEL
03-4411-7700
Homepage URL
knagano4@ITS.JNJ.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NPO MINS
Address
1-15-14, Dogenzaka, Shibuya-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2021 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/12/5/e060081
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
136
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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 17 | Day |
Date analysis concluded
Other
Other related information
This is a prospective, observational study in which physicians and patients will follow local clinical practice in Japan.
Management information
Registered date
| 2021 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049893
