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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043753
Receipt No. 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 2021/07/19

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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
Email 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
Email knagano4@ITS.JNJ.com

Sponsor
Institute Janssen Pharmaceutical K.K
Institute
Department

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
Email 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
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
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
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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
2021 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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